‫وقعت Tuya شراكة استراتيجية مع شركة China Mobile International لتعزيز نموذج الأعمال الجديد للذكاء الرقمي

دبي، الإمارات العربية المتحدة، 12 أكتوبر 2022 / PRNewswire / — شركة Tuya Smart (“Tuya ” أو “الشركة”) (المدرجة في بورصة نيويورك تحت الرمز: TUYA, HKEX: 2391) المزود العالمي لخدمات منصة تطوير إنترنت الأشياء، وشركة China Mobile International بالشرق الأوسط ( (CMI ، وقعا شراكة استراتيجية في GITEX Global 2022 لتعزيز نشر وتنفيذ حلول ومشاريع إنترنت الأشياء في جميع أنحاء الشرق الأوسط وأفريقيا. كما قرروا أنهم سيقدمون معًا المزيد من الدعم الفني للمشاهد الذكية، مثل الأعمال الذكية والمدن الذكية والمزيد.

“تعد شركة China Mobile International شريكًا مهمًا لشركة Tuya ويعمل الطرفان باستمرار معًا على دفع عجلة تطوير إنترنت الأشياء. وبمساعدة China Mobile وشركاء القنوات الآخرين، يمكن للأجهزة الذكية التي تدعم Tuya أن تدخل بسرعة إلى آلاف الأسر في جميع أنحاء العالم. ومن خلال التعاون الاستراتيجي اليوم مع CMI ، ستواصل Tuya اختيار المنتجات عالية الجودة التي تدعم Tuya وحلول الأعمال الكاملة ل CMI ، والعمل معًا لتسريع التنفيذ الناضج للأعمال الذكية في الشرق الأوسط وأفريقيا”. هذا ما قاله جوني لو، المدير العام لمنطقة LATEM في Tuya Smart .

“تلتزم CMI بتوفير بيئة معلومات أكثر ملاءمة لشركاء شركات الاتصالات والعملاء من المؤسسات ومستخدمي الهواتف المحمولة، والمساعدة في تمكين التحول الرقمي لمختلف الصناعات. ومن خلال الاستفادة من بنيتنا التحتية الرقمية العالمية والنظام البيئي لإنترنت الأشياء في Tuya ، نتطلع إلى إنشاء نظام بيئي معًا من خلال هذا التعاون، وتوفير خدمات استخبارات رقمية كاملة للشركات داخل منطقة الشرق الأوسط وأفريقيا وخارجها”. هذا ما قاله كولين وانغ، العضو المنتدب لشركة CMI لمنطقة الشرق الأوسط وأفريقيا.

CMI تستكشف سوق إنترنت الأشياء في منطقة الشرق الأوسط وأفريقيا من خلال منصة إنترنت الأشياء الذكية الشاملة RINGA

تأسست CMI ، وهي شركة تابعة لشركة China Mobile ، رسميًا في هونغ كونغ، الصين في ديسمبر 2010 لتقديم خدمات أفضل لتلبية الطلب المتزايد في سوق الاتصالات الدولية. وبالاستفادة من الدعم القوي من قبل China Mobile ، توفر CMI خدمات وحلول اتصالات دولية شاملة للشركات الدولية وشركات الاتصالات ومستخدمي الهواتف المحمولة. توفر CMI iSolutions 5 ركائز للخدمات للعملاء العالميين من المؤسسات، بما في ذلك تكامل الشبكة السحابية والاتصال ومركز البيانات وتكنولوجيا المعلومات والاتصالات وإنترنت الأشياء. تغطي محفظة خدماتها أكثر من 50 حلًا صناعيًا عبر الخدمات اللوجستية والمالية والتصنيع والبيع بالتجزئة بالإضافة إلى حلول لتكامل الشبكات السحابية والشركات متعددة الجنسيات وقطاعات إنترنت الأشياء وما إلى ذلك، مع الالتزام بمساعدة الشركات على توسيع أعمالها العالمية بشكل أكثر كفاءة.

مع التوسع المستمر في نطاق تطبيقات إنترنت الأشياء العالمي، أطلقت CMI RINGA ، وهي منصة IoT PaaS ، تدمج خدمات إنترنت الأشياء الشاملة في الأجهزة والأنظمة الأساسية والتطبيقات. تربط RINGA بين مزودي خدمات إنترنت الأشياء العالميين ومصنعي الأجهزة الذكية وتجار التجزئة لأجهزة إنترنت الأشياء لمساعدة الشركات والمشغلين العالميين على بناء تطبيقات إنترنت الأشياء الشاملة بسرعة.

من خلال التعاون المتعمق بين الطرفين، طورت CMI تطبيق RINGA + APP الذي يربط مختلف فئات وعلامات تجارية للأجهزة المنزلية الذكية بالمنصة. في المستقبل، سيتم توسيع منصة RINGA + لتشمل الشقق الذكية والفنادق الذكية والمكاتب الذكية والمصانع الذكية وغيرها من سيناريوهات التطبيقات الذكية المتنوعة لزيادة تلبية احتياجات تطبيق إنترنت الأشياء لجميع مناحي الحياة.

قدمت Tuya حل Cube Solution في GITEX لدعم العملاء العالميين من خلال مساعدتهم على إنشاء منصات إنترنت الأشياء الخاصة بهم

وبصفتها مزودًا عالميًا لخدمات منصة تطوير إنترنت الأشياء، تلتزم Tuya بتزويد شركائها بدعم النظام الإيكولوجي المفتوح والمحايد لإنترنت الأشياء والتقنيات المتقدمة والقيمة. اعتبارًا من 30 يونيو 2022، كان لدى Tuya أكثر من 629,000 مطور في أكثر من 200 دولة ومنطقة، مع أكثر من 2,200 فئة منتجات ممكنة. كما عرضت Tuya حلها Cube Solution في GITEX Global 2022 .

حل Cube Solution هو حل خاص لنشر خدمة إنترنت الأشياء تم إطلاقه في وقت سابق من العام. ضمن حل Cube Solution ، يمكن للمطورين إنشاء منصة إنترنت الأشياء الخاصة القابلة للتطوير للتعامل مع إدارة الأجهزة والاتصال وتطوير التطبيقات وتحليلات البيانات. يسمح حل Cube Solution للشركات بتوصيل أجهزة إنترنت الأشياء وإدارتها، وتطوير التطبيقات بسرعة، وتوفير خدمات أمن البيانات، والتوسع التلقائي للنظام، وكل ذلك مدعوم ب IoT PaaS المثبتة من Tuya . يساعد حل Cube Solution المؤسسات على مواكبة الطلب المتغير باستمرار على تقنيات إنترنت الأشياء في الأعمال التجارية وإنشاء عمليات منصة إنترنت الأشياء المخصصة لكل قطاع صناعي وكل سيناريو بسرعة.

ويوضح التعاون بين Tuya و CMI أن كلا الطرفين سيجمعان بين المزايا التقنية والبيئية لتعزيز حلول إنترنت الأشياء في منطقتي الشرق الأوسط وأفريقيا وتحسين القدرة على تقديم الحلول في جميع أنحاء العالم. بالإضافة إلى ذلك، ستأخذ Tuya هذه الفرصة كفرصة لتنمية أسواق الشرق الأوسط وأفريقيا باستمرار، وتعزيز تنفيذ المشاهد الذكية باستمرار، وتوفير المزيد من حالات التطبيق وموارد السوق لشركاء النظام البيئي.

نُبذة عن شركة Tuya Smart

شركة Tuya Smart (بورصة نيويورك: TUYA, HKEX: 2391) هي شركة تكنولوجيا رائدة تركز على جعل حياتنا أكثر ذكاء. تقوم Tuya بذلك من خلال تقديم منصة سحابية تربط مجموعة من الأجهزة عبر إنترنت الأشياء. من خلال بناء معايير الترابط، تجسر Tuya الاحتياجات الذكية للعلامات التجارية ومصنعي المعدات الأصلية والمطورين وسلاسل البيع بالتجزئة عبر مجموعة واسعة من الأجهزة والصناعات الذكية. تعمل حلول Tuya على تمكين الشركاء والعملاء من خلال تحسين قيمة منتجاتهم مع جعل حياة المستهلكين أكثر ملاءمة من خلال تطبيق التكنولوجيا. من خلال أعمالها التجارية المتنامية SaaS ، تقدم Tuya حلول أعمال ذكية لمجموعة واسعة من القطاعات. منصة الشركة مدعومة بتكنولوجيا رائدة في الصناعة كاملة مع حماية البيانات وأمنها الصارمين. تتعاون Tuya مع الشركات الرائدة المدرجة في قائمة Fortune 500 من جميع أنحاء العالم لجعل الأمور أكثر ذكاء، بما في ذلك Philips ، و Schneider Electric ، و Lenovo وغيرها الكثير.

GWM New Energy Vehicles See Up to 14% YoY, More New Models for Global Market

BAODING, China, Oct. 12, 2022 /PRNewswire/ — On October 10, the latest sales data released by GWM showed that the accumulative number of new energy vehicles sold from January to September reached 96,916, increased by 14.31% year-on-year, marking the brand’s improvement of competitiveness in the new energy market.

GWM New Energy Vehicles See Up to 14% YoY, More New Models for Global Market

GWM has launched a number of new energy products, covering HEV, PHEV, and EV power forms, and achieved sales breakthroughs in the global market.

As a single brand, HAVAL has released various hybrid vehicles, among which the H6 PHEV and H6 HEV have outstanding sales performance.

The HAVAL H6 PHEV was officially launched in China and Thailand recently. At the launch in Thailand, the number of orders for this model reached 1,000 within 40 minutes.

The HAVAL H6 PHEV, equipped with a 1.5GDIT engine and an internationally leading 2-Speed Dedicated Hybrid Transmission (DHT), can automatically switch to the most suitable driving mode for a specific driving scenario, such as the electric or hybrid ones while maintaining a balance between power and fuel consumption.

After a test drive, Autohome, a well-known automotive website in China, commented, “The gear shift operation of HAVAL H6 PHEV is very smooth, and there is no feeling of pause or jerk at all. When the vehicle reaches the high-speed range, with the support of the turbocharged engine, there is still a powerful and sustainable acceleration.”

The hybrid edition of HAVAL H6 has been launched in various markets, such as Thailand, Australia, and South Africa, and has achieved excellent market performance.

ORA, a pure electric car brand of GWM, has also achieved excellent sales performance. According to the sales data released by the company, the number of ORA sold globally from January to September this year is 84,721. In Thailand, statistics from Autolife Thailand show that from January to August this year, ORA GOOD CAT (also known as the FUNKY CAT in some overseas markets) ranked first in local EV sales, with a high market share of 42.4%.

WEY COFFEE 01, another new energy vehicle of GWM, was included in the “List of Eligible Electric Vehicles” of the German Federal Office for Economic Affairs and Export Control (BAFA) on October 10. The two versions of the vehicle are priced at 55,900 EUR and 59,900 EUR respectively.

GWM attaches importance to the network security management of vehicles. The ORA FUNKY CAT and WEY COFFEE 01 are in line with UN Regulation No. 155. These two vehicles will soon be available in Europe.

Currently, GWM’s new energy transformation is revving up. The company plans to launch more new energy models with different features in the global market and maintain momentum in sales growth.

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DXC Technology Rolls Out Global Initiative to Support Neurodiversity in the Workplace

Award-winning DXC Dandelion Program expanded across Europe and APAC

LONDON, Oct. 12, 2022 /PRNewswire/ — DXC Technology (NYSE: DXC) a leading Fortune 500 global technology services provider, is expanding the DXC Dandelion Program which helps neurodivergent individuals with autism, ADHD, dyslexia and other neurological conditions to build careers in the IT industry.

DXC Dandelion Program Co-ordinator, Felicia Vozza working with Daniel, a DXC Dandelion participant (Credit: DXC)

Following the success of the program in Australia and New Zealand, DXC is now launching the initiative across European and Asia Pacific countries. The United Kingdom will be first to launch, building on a 12-month pilot, with Bulgaria, Poland and the Philippines to follow.

Recruitment is now open across the new locations with employment opportunities in various fields including data analytics, software automation, user experience and cybersecurity.

The DXC Dandelion Program was launched in 2014 in Australia with a focus on creating employment pathways and careers for neurodivergent individuals within the IT industry. With no prior professional experience required to participate, DXC has made the program available to individuals of all abilities with the motivation to work in technology. In addition to offering employment, DXC provides participants with technical and vocational training plus professional support by specialised consultants.

Michael Fieldhouse, Social Impact Practice Leader at DXC Technology APAC, who is responsible for the DXC Dandelion Program, emphasizes that “neurodivergent individuals often have an extraordinary ability to think visually and to care for details. These are valuable skills, especially in areas of IT such as cybersecurity and data analytics. By creating an equitable and positive working environment, and by providing the right support framework, we are giving participants of DXC Dandelion the best chance to succeed.”

DXC Dandelion Program in Numbers:

  • Employment opportunities created for more than 200 individuals to date
  • 92% employment retention rate
  • 30-40% increase in the overall productivity of teams which participate in the program
  • Recognized by industry organizations globally, winning 17 international awards for its contribution to the development of socially beneficial initiatives
  • Recognized in the Top-Scoring Companies list by the Global Disability Equality Index, achieving a score of 100% for the company’s disability and inclusion achievements in the last three years
  • A pilot of the program began in UK in 2021, providing 15 neurodivergent individuals with employment opportunities
  • Participants have the opportunity to work on customer projects. For example, the UK’s Department of Health and Social Care (DHSC), where 4 individuals are working on software testing and User Experience (UX) as part of DXC’s contract to support the Information Management Services 4 (IMS4) program.

Chris Halbard, President of DXC Technology, EMEA, added “As we continue to grow, it’s important that we invest in the communities where we do business and recognize the positive impact of diversity in the workplace. That’s why we are extending DXC Dandelion across Europe and worldwide, helping neurodivergent individuals unlock their unique talents and bring success to themselves, DXC and our customers.”

Cooperation with NGOs

DXC Technology cooperates with non-governmental organizations, foundations and educational institutions which help to expand the reach and impact of the DXC Dandelion Program and supports identifying and selecting participants who could benefit.

“Disparities in employment participation rates for neurodivergent individuals is a global issue that merits our concerted attention,” said Professor of Disability Studies, Academic Director, Susanne Bruyere, Yang-Tan Institute on Employment and Disability, Cornell University ILR School. “Cornell University is pleased to partner with DXC Technology as it further moves the DXC Dandelion Program globally to make information about these targeted neurodiversity hiring initiatives more broadly available through a partnership for an online portal that shares related program information.”

To find out more and watch a video about the DXC Dandelion program including the views of participants, please visit:

https://dxc.com/uk/en/about-us/social-values/dxc-dandelion-program

About the DXC Dandelion Program

The DXC Dandelion Program provides an environment that supports and celebrates the talents and skills of neurodivergent individuals— such as those with Autism, ADHD or Dyslexia — and helps them build valuable skills to pursue a career in information technology. Learn more about how we are supporting neurodiversity in the workforce at DXC.com

About DXC Technology

DXC Technology (NYSE: DXC) helps global companies run their mission-critical systems and operations while modernizing IT, optimizing data architectures, and ensuring security and scalability across public, private and hybrid clouds. The world’s largest companies and public sector organizations trust DXC to deploy services to drive new levels of performance, competitiveness, and customer experience across their IT estates. Learn more about how we deliver excellence for our customers and colleagues at DXC.com

Aleksandra Andreasik-Binkowska, DXC EMEA, a.andreasikbinkowska@dxc.com

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Merck and Moderna Announce Exercise of Option by Merck for Joint Development and Commercialization of Investigational Personalized Cancer Vaccine

Companies on track to report data from the ongoing Phase 2 trial of mRNA-4157/V940 in combination with KEYTRUDA® as adjuvant therapy in high-risk melanoma in 4Q 2022

CAMBRIDGE, MA and RAHWAY, NJ / ACCESSWIRE / October 12, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that Merck has exercised its option to jointly develop and commercialize personalized cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing Collaboration and License Agreement. mRNA-4157/V940 is currently being evaluated in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma in a Phase 2 clinical trial being conducted by Moderna.

“We have been collaborating with Merck on PCVs since 2016, and together we have made significant progress in advancing mRNA-4157 as an investigational personalized cancer treatment used in combination with KEYTRUDA,” said Stephen Hoge, M.D., President of Moderna. “With data expected this quarter on PCV, we continue to be excited about the future and the impact mRNA can have as a new treatment paradigm in the management of cancer. Continuing our strategic alliance with Merck is an important milestone as we continue to grow our mRNA platform with promising clinical programs in multiple therapeutic areas.”

Under the agreement, originally established in 2016 and amended in 2018, Merck will pay Moderna $250 million to exercise its option for personalized cancer vaccines including mRNA-4157/V940 and will collaborate on development and commercialization. The payment will be expensed by Merck in the third quarter of 2022 and included in its non-GAAP results. Merck and Moderna will share costs and any profits equally under this worldwide collaboration.

“This long-term collaboration combining Merck’s expertise in immuno-oncology with Moderna’s pioneering mRNA technology has yielded a novel tailored vaccine approach,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to working with our colleagues at Moderna to advance mRNA-4157/V940 in combination with KEYTRUDA as it aligns with our strategy to impact early-stage disease.”

About mRNA-4157/V940

Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response to their tumor mutation signature to treat their cancer. mRNA-4157/V940 is designed to stimulate an immune response by generating T cell responses based on the mutational signature of a patient’s tumor.

About KEYNOTE-942 (NCT03897881)

KEYNOTE-942 is an ongoing randomized, open-label Phase 2 trial that enrolled 157 patients with high-risk melanoma. Following complete surgical resection, patients were randomized to mRNA-4157/V940 (9 doses every three weeks) and KEYTRUDA (200 mg every three weeks) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity. KEYTRUDA was selected as the comparator in the trial because it is considered a standard of care for high-risk melanoma patients. The primary endpoint is recurrence-free survival, and secondary endpoints include distant metastasis-free survival and overall survival. The Phase 2 trial is fully enrolled and primary data are expected in the fourth quarter of 2022.

About KEYTRUDA® (pembrolizumab) Injection 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

  • stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
  • metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):

  • who are not eligible for any platinum-containing chemotherapy, or
  • who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Non-muscle Invasive Bladder Cancer

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test.

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

  • in combination with platinum- and fluoropyrimidine-based chemotherapy, or
  • as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Cervical Cancer

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Endometrial Carcinoma

KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti-PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti-PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti-PD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after anti-PD-1/PD-L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between anti-PD-1/PD-L1 treatment and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using anti-PD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an anti-PD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (≥20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, when KEYTRUDA was administered as a single agent to patients with stage III melanoma, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (≥1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (≥20%) with KEYTRUDA was diarrhea (28%). In KEYNOTE-716, when KEYTRUDA was administered as a single agent to patients with stage IIB or IIC melanoma, adverse reactions occurring in patients with stage IIB or IIC melanoma were similar to those occurring in 1011 patients with stage III melanoma from KEYNOTE-054.

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (≥20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (≥20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (≥20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (≥20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-204, KEYTRUDA was discontinued due to adverse reactions in 14% of 148 patients with cHL. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA; those ≥1% were pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Three patients died from causes other than disease progression: 2 from complications after allogeneic HSCT and 1 from unknown cause. The most common adverse reactions (≥20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, rash, and cough (20% each).

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those ≥1% were pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression: 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (≥20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (≥20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or mUC. Serious adverse reactions occurred in 42% of patients; those ≥2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (≥20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or mUC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those ≥2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (≥20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those ≥2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (≥20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with MSI-H or dMMR CRC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-811, when KEYTRUDA was administered in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 6% of 217 patients with locally advanced unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma. The most common adverse reaction resulting in permanent discontinuation was pneumonitis (1.4%). In the KEYTRUDA arm versus placebo, there was a difference of ≥5% incidence between patients treated with KEYTRUDA versus standard of care for diarrhea (53% vs 44%) and nausea (49% vs 44%).

The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, and insomnia.

In KEYNOTE-590, when KEYTRUDA was administered with cisplatin and fluorouracil to patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation, KEYTRUDA was discontinued due to adverse reactions in 15% of 370 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were pneumonitis (1.6%), acute kidney injury (1.1%), and pneumonia (1.1%). The most common adverse reactions (≥20%) with KEYTRUDA in combination with chemotherapy were nausea (67%), fatigue (57%), decreased appetite (44%), constipation (40%), diarrhea (36%), vomiting (34%), stomatitis (27%), and weight loss (24%).

Adverse reactions occurring in patients with esophageal cancer who received KEYTRUDA as a monotherapy were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-826, when KEYTRUDA was administered in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab (n=307), to patients with persistent, recurrent, or first-line metastatic cervical cancer regardless of tumor PD-L1 expression who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent, fatal adverse reactions occurred in 4.6% of patients, including 3 cases of hemorrhage, 2 cases each of sepsis and due to unknown causes, and 1 case each of acute myocardial infarction, autoimmune encephalitis, cardiac arrest, cerebrovascular accident, femur fracture with perioperative pulmonary embolus, intestinal perforation, and pelvic infection. Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with chemotherapy with or without bevacizumab; those ≥3% were febrile neutropenia (6.8%), urinary tract infection (5.2%), anemia (4.6%), and acute kidney injury and sepsis (3.3% each).

KEYTRUDA was discontinued in 15% of patients due to adverse reactions. The most common adverse reaction resulting in permanent discontinuation (≥1%) was colitis (1%).

For patients treated with KEYTRUDA, chemotherapy, and bevacizumab (n=196), the most common adverse reactions (≥20%) were peripheral neuropathy (62%), alopecia (58%), anemia (55%), fatigue/asthenia (53%), nausea and neutropenia (41% each), diarrhea (39%), hypertension and thrombocytopenia (35% each), constipation and arthralgia (31% each), vomiting (30%), urinary tract infection (27%), rash (26%), leukopenia (24%), hypothyroidism (22%), and decreased appetite (21%).

For patients treated with KEYTRUDA in combination with chemotherapy with or without bevacizumab, the most common adverse reactions (≥20%) were peripheral neuropathy (58%), alopecia (56%), fatigue (47%), nausea (40%), diarrhea (36%), constipation (28%), arthralgia (27%), vomiting (26%), hypertension and urinary tract infection (24% each), and rash (22%).

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with previously treated recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with HCC were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 3-4) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (≥20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

In KEYNOTE-581, when KEYTRUDA was administered in combination with LENVIMA to patients with advanced renal carcinoma (n=352), fatal adverse reactions occurred in 4.3% of patients. Serious adverse reactions occurred in 51% of patients, the most common (≥2%) were hemorrhagic events (5%), diarrhea (4%), hypertension (3%), myocardial infarction, pneumonitis, and vomiting (3% each), acute kidney injury, adrenal insufficiency, dyspnea, and pneumonia (2% each).

Permanent discontinuation of either of KEYTRUDA, LENVIMA, or both due to an adverse reaction occurred in 37% of patients; 29% KEYTRUDA only, 26% lenvatinib only, and 13% both. The most common adverse reactions (≥2%) resulting in permanent discontinuation of KEYTRUDA, LENVIMA, or the combination were pneumonitis (3%), myocardial infarction, hepatotoxicity, acute kidney injury, and rash (3% each), and diarrhea (2%).

The most common adverse reactions (≥20%) observed with KEYTRUDA in combination with LENVIMA were fatigue (63%), diarrhea (62%), musculoskeletal disorders (58%), hypothyroidism (57%), hypertension (56%), stomatitis (43%), decreased appetite (41%), rash (37%), nausea (36%), weight loss, dysphonia and proteinuria (30% each), palmar-plantar erythrodysesthesia syndrome (29%), abdominal pain and hemorrhagic events (27% each), vomiting (26%), constipation and hepatotoxicity (25% each), headache (23%), and acute kidney injury (21%).

In KEYNOTE-564, when KEYTRUDA was administered as a single agent for the adjuvant treatment of renal cell carcinoma, serious adverse reactions occurred in 20% of patients receiving KEYTRUDA; the serious adverse reactions (≥1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% including 1 case of pneumonia. Discontinuation of KEYTRUDA due to adverse reactions occurred in 21% of 488 patients; the most common (≥1%) were increased ALT (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions (≥20%) were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%).

In KEYNOTE-775, when KEYTRUDA was administered in combination with LENVIMA to patients with advanced endometrial carcinoma that were not MSI-H or dMMR (n=342), fatal adverse reactions occurred in 4.7% of patients. Serious adverse reactions occurred in 50% of these patients; the most common (≥3%) were hypertension (4.4%) and urinary tract infections (3.2%).

Discontinuation of KEYTRUDA, due to an adverse reaction occurred in 15% of these patients. The most common adverse reaction leading to discontinuation of KEYTRUDA (≥1%) was increased ALT (1.2%).

The most common adverse reactions for KEYTRUDA in combination with LENVIMA (reported in ≥20% patients) were hypothyroidism and hypertension (67% each), fatigue (58%), diarrhea (55%), musculoskeletal disorders (53%), nausea (49%), decreased appetite (44%), vomiting (37%), stomatitis (35%), abdominal pain and weight loss (34% each), urinary tract infections (31%), proteinuria (29%), constipation (27%), headache (26%), hemorrhagic events (25%), palmar-plantar erythrodysesthesia (23%), dysphonia (22%), and rash (20%).

Adverse reactions occurring in patients with MSI-H or dMMR endometrial carcinoma who received KEYTRUDA as a single agent were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.

Adverse reactions occurring in patients with TMB-H cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-522, when KEYTRUDA was administered with neoadjuvant chemotherapy (carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide) followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent (n=778) to patients with newly diagnosed, previously untreated, high-risk early-stage TNBC, fatal adverse reactions occurred in 0.9% of patients, including 1 each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those ≥2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). KEYTRUDA was discontinued in 20% of patients due to adverse reactions. The most common reactions (≥1%) resulting in permanent discontinuation were increased ALT (2.7%), increased AST (1.5%), and rash (1%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%).

In KEYNOTE-355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued in 11% of patients due to adverse reactions. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%).

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the final dose.

Pediatric Use

In KEYNOTE-051, 161 pediatric patients (62 pediatric patients aged 6 months to younger than 12 years and 99 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. The median duration of exposure was 2.1 months (range: 1 day to 24 months).

Adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults were pyrexia (33%), vomiting (30%), leukopenia (30%), upper respiratory tract infection (29%), neutropenia (26%), headache (25%), and Grade 3 anemia (17%).

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.

Merck’s focus on cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on TwitterFacebookInstagramYouTube and LinkedIn.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2021 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the development of personalized cancer vaccines pursuant to the collaboration agreement between Moderna and Merck and the terms of that agreement; the potential advancement of personalized cancer vaccines through clincal trials and the receipt of regulatory approvals; the payment of $250 million by Merck to Moderna; and the timing for the release of data from the Phase 2 study of mRNA-4157. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Merck Contacts

Media:
Justine Moore
(908) 740-6449

Julie Cunningham
(617) 519-6264

Investors:
Peter Dannenbaum
(908) 740-1037
Damini Chokshi
(908) 740-1807

Moderna Contacts

Media:
Mary Beth Woodin
Senior Director, R&D Communications
617-899-3991
MaryBeth.Woodin@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President& Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

 

Human Rights Council Concludes General Debate on Human Rights Bodies and Mechanisms, Holds General Debate on the Universal Periodic Review

The Human Rights Council this morning concluded its general debate on human rights bodies and mechanisms, and held a general debate on the Universal Periodic Review.

Among the issues raised by speakers in the continuing general debate on human rights bodies and mechanisms was that all States should abide by their commitments made to the Human Rights Council and its mechanisms, and respond to communications made by the mandate holders and treaty bodies. The situation of indigenous peoples across the world was also an issue of concern for many speakers, who expressed concern at their loss of traditional lands and having to leave their traditional homes. The failure to investigate by the United Nations was a main cause of the increase in human rights violations, according to some speakers, and the Special Procedures should be strengthened in order to produce stronger relief on the ground and where there was a dire need. A number of speakers said attacks on human rights defenders were becoming common across the world, with many Governments targeting them with arbitrary arrests, disappearances, and other forms of harassment, with women human rights defenders in particular suffering from a wide range of sexual-based threats.

In the general debate on the Universal Periodic Review, some speakers commended the Universal Periodic Review process, describing it as the crown jewel of the Human Rights Council, and one of its greatest successes. The ground-breaking peer review mechanism provided a platform for meaningful dialogue where States could highlight national efforts and achievements, share best practices, and offer constructive feedback to better address human rights challenges. Some speakers said the Universal Periodic Review process needed to be conducted objectively, based on reliable information. It should not be used as a tool to interfere with the sovereignty of States and question their political systems, cultures, or religious particularities. A number of speakers highlighted specific recommendations from the Universal Periodic Review process which had not been upheld by certain States.

Speaking in the general debate on human rights bodies and mechanisms were International Muslim Women’s Union, Society for Development and Community Empowerment, Union of Northwest Human Rights Organization, World Barua Organization, Global Welfare Association, American Association of Jurists, World Muslim Congress, World Alliance for Citizen Participation, International Humanist and Ethnical Unions, Promotion du Développement Economique et Social, iuventum e.V., Platform for Youth Integration and Volunteerism, Alliance Creative Community Project, Shaanxi Patriotic Volunteer Association, Réseau Unité pour le Développement de Mauritanie, Global Appreciation and Skills Training Network, Alsalam Foundation, Partners for Transparency, Al Baraem Association for Charitable Work, Fitilla, Community Human Rights and Advocacy Centre, Al-Hakim Foundation, Indigenous People of Africa Coordinating Committee, Association pour l’Intégration et le Développement Durable au Burundi, Commission africaine des promoteurs de la santé et des droits de l’homme, Association Burkinabé pour la Survie de l’Enfance, and Jeunesse Etudiante Tamoule.

Speaking in the general debate on the Universal Periodic Review were Malaysia on behalf of the Association of Southeast Asian Nations, Czech Republic on behalf of the European Union and a group of other countries, Pakistan on behalf of the Organization for Islamic Cooperation, Azerbaijan on behalf of the Non-Aligned Movement, Palestine on behalf of the Arab Group, Belgium on behalf of the Group of French-Speaking Countries, India, Bhutan on behalf of a group of countries, Finland, Cuba, Venezuela, Libya, China, Armenia, Indonesia, Malaysia, Malawi, Mauritania, Tunisia, Iraq, Samoa, Slovenia, Morocco, Bahrain, Ethiopia, South Africa, Algeria, United Nations Population Fund, Georgia, Suriname, Saint Vincent and the Grenadines, South Sudan, Iran, Dominican Republic, and Cambodia.

Also speaking were Centre catholique international de Genève, Maat for Peace, Development and Human Rights Association, Syrian Center for Media and Freedom of Expression, Action Canada for Population and Development, Global Life Savers Inc., Partners For Transparency, Global Appreciation and Skills Training Network, Association Burkinabé pour la Survie de l’Enfance, Tamil Uzhagam, United Towns Agency for North-South Cooperation, Right Livelihood Award Foundation, International Council Supporting Fair Trial and Human Rights, Americans for Democracy & Human Rights in Bahrain Inc., Amnesty International, Association des étudiants tamouls de France, Association pour la Défense des Droits de Développement Durable et du Bien-être Familial, World Alliance for Citizen Participation, Society for Development and Community Empowerment, Fitilla, International Yazidis Foundation for the Prevention of Genocide, Platform for Youth Integration and Volunteerism, Lawyers’ Rights Watch Canada, Association Bharathi Centre Culturel Franco-Tamoul, Association Culturelle des Tamouls en France, Jeunesse Etudiante Tamoule, and Association pour l’Intégration et le Développement Durable au Burundi.

Speaking in right of reply were China, Indonesia, and Venezuela.

The webcast of the Human Rights Council meetings can be found here. All meeting summaries can be found here. Documents and reports related to the Human Rights Council’s fifty-first regular session can be found here.

The Council will resume its work at 3 p.m. this afternoon to hold a general debate under agenda item seven on the human rights situation in Palestine and other occupied Arab territories, followed by a general debate under agenda item eight on follow-up to and implementation of the Vienna Declaration and Programme of Action.

General Debate on Agenda Item Five on Human Rights Bodies and Mechanisms

The general debate on agenda item five on human rights bodies and mechanisms started in the previous meeting and a summary can be found here.

General Debate on Human Rights Bodies and Mechanisms

Among issues raised by speakers in the continuing general debate was the fact that international human rights law laid down obligations which States were obligated to respect. The democratic space for civil society was shrinking worldwide, with the space for freedom of speech also shrinking, both of which were essential for a free and democratic society. Some speakers said all States should abide by their commitments made to the Human Rights Council and its mechanisms, and respond to communications made by the mandate holders and treaty bodies. All States should extend standing invitations to all Special Procedure mandate holders.

The situation of indigenous peoples across the world was also an issue of concern for many speakers, who expressed concern at their loss of traditional lands and having to leave their traditional homes. There were many cases of violence perpetrated against indigenous peoples by companies, violating their rights, causing the death of their children. This also resulted in a grievous loss of biodiversity. The issue of religious persecution was also raised by a speaker, who noted that in some areas of the world, the practice of certain religions was becoming ever more difficult.

The failure to investigate by the United Nations was a main cause of the increase in human rights violations, according to some speakers, and the Special Procedures should be strengthened in order to produce stronger relief on the ground and where there was a dire need. Human rights should be promoted in accordance with human rights mechanisms, and technical cooperation should be promoted across the board, including with civil society.

A number of speakers said attacks on human rights defenders were becoming common across the world, with many Governments targeting them with arbitrary arrests, disappearances, and other forms of harassment, with women human rights defenders in particular suffering from a wide range of sexual-based threats. United Nations Member States should bring those who were guilty of committing gross human rights violations before the International Criminal Court. The Human Rights Council should appoint country-specific mandates to monitor the situation in countries where such violations occurred.

One speaker also raised the issue of the length of statements by non-governmental organizations to the Human Rights Council, saying that 90 seconds was too short.

General Debate on the Universal Periodic Review

Speakers in the general debate commended the Universal Periodic Review process, describing it as the crown jewel of the Human Rights Council, and one of its greatest successes. The ground-breaking peer review mechanism provided a platform for meaningful dialogue where States could highlight national efforts and achievements, share best practices, and offer constructive feedback to better address human rights challenges. It had strengthened cooperation and engagements between States and a wide range of stakeholders, including civil society and national human rights institutions, among others. Through positive and constructive interactions, States were able to demonstrate tangible progress in the promotion and protection of human rights, including through voluntary policy and institutional reforms.

At the commencement of the fourth Universal Periodic Review cycle, speakers had reiterated their full support to the process. Speakers remained strongly committed to the Universal Periodic Review mechanism, which had the overarching goal of improving human rights worldwide. The Office of the High Commissioner for Human Rights was commended for its smooth running of the Universal Periodic Review process.

Some speakers said the Universal Periodic Review process needed to be conducted objectively, based on reliable information. It should not be used as a tool to interfere with the sovereignty of States and question their political systems, cultures, or religious particularities. The process needed to remain an intergovernmental process, driven by United Nation members on an equal footing, and oriented towards cooperation, in an objective, transparent, and non-politicised manner. Speakers stressed that it was essential to ensure that the Universal Periodic Review process was carried out by the Human Rights Council, with full participation of the country under review, with capacity building needs taken into account.

A number of speakers said they were not willing to negotiate the basic principles and functioning of the Universal Periodic Review, which should be preserved. They expressed concern about the sending and publication of letters to countries, privileging some recommendations and ignoring others, calling on the Office of the High Commissioner to eliminate this practice. During the process of country-specific human rights deliberations, countries were urged to carry out sincere dialogue and to avoid smearing and exerting pressure in the name of comments and suggestions. Some speakers rejected the fact that the Council be used to impose selective and politicised initiatives, through costly resolutions against specific countries, which were ineffective. A number of speakers highlighted specific recommendations from the Universal Periodic Review process which had not been upheld by certain States. Others said that in some cases, the mechanism had failed to protect cultural groups from genocide, proposing that the Council hold a special session dedicated to the victims, and to recommend that the States involved appear before the International Criminal Court.

Some speakers underlined the importance of providing capacity building and technical cooperation to States, to facilitate the meaningful implementation of accepted Universal Periodic Review recommendations. The Universal Periodic Review process required the meaningful and unhindered participation of all stakeholders, which included States, government officials, and civil society organizations. States were urged to take the necessary measures to ensure and enhance civil society cooperation in their work without fear of reprisals or intimidation, either at home or abroad.

A number of speakers believed that national parliaments, as well as civil society, should be involved in national consultation processes prior to the Universal Periodic Review process. These groups were essential in ensuring the process had a tangible impact on the ground, ensuring that actual changes were brought about in human rights. States under review were strongly encouraged to follow up on recommendations received during the Universal Periodic Review cycle, as a means of making progress in their human rights situations.

Source: UN Human Rights Council

Le Burundi sur la voie d’une infrastructure routière résiliente au changement climatique

Ce 6 octobre, la Banque mondiale a approuvé un financement pour le Burundi afin qu’il soit doté d’une infrastructure routière résiliente au changement climatique. Le projet va renforcer la capacité institutionnelle à planifier et à préserver durablement des actifs routiers résilients au climat.

Le groupe de la Banque mondiale a accordé un financement de 120 millions de dollars pour le projet de résilience des transports au Burundi. Ce financement vise à fournir une connectivité routière, efficace, sûre et résiliente au changement climatique sur le long de la route nationale n°3 qui relie le Burundi à la Tanzanie.

Pour la banque mondiale, ce projet comprend des composantes qui se renforcent mutuellement et qui permettent d’améliorer et d’accroître la résilience des infrastructures routières. Ces composantes s’attaquent à certaines causes de la dégradation des routes. Elles fournissent aussi une infrastructure sociale adaptée à la communauté et protègent les usagers vulnérables.

Grâce à un accès routier résilient, sûr et ouvert tout au long de l’année, la Banque mondiale indique que le projet va contribuer à relier la population aux marchés, à accroître les échanges commerciaux et à améliorer l’accès aux opportunités. Elle confie que les principaux bénéficiaires sont les transporteurs et les voyageurs, les habitants de la ville de Bujumbura, de la commune de Kabezi de la province de Bujumbura et de la commune de Muhuta de la province de Rumonge.

Le projet répondra aux besoins identifiés du secteur, tels que le renforcement de la capacité de gestion routière et la formation de spécialistes des transports, avec un accent particulier sur l’intégration des femmes.

En plus des investissements, « le renforcement des capacités institutionnelles et les activités de développement des ressources humaines financées au titre de ce projet sont indispensables pour aider le pays à réaliser ses objectifs de développement sectoriel ainsi que pour jeter les bases d’un secteur des transports efficaces et durable » a déclaré Hawa Cissé Wagué, représentante résidente de la banque mondiale au Burundi.

Ce projet de résilience des transports au Burundi est financé par l’Association internationale de développement (Ida) et sera mis en œuvre sur cinq ans.

Source: IWACU Burundi