RAHWAY, N.J.--(BUSINESS WIRE)---- $MRK #MRK--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the final analysis of the pivotal Phase 3 KEYNOTE- B96 trial, also known as ENGOT-ov65, showing that KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab significantly improved overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer re ...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced KEYTRUDA® (pembrolizumab) plus Padcev ® (enfortumab vedotin-ejfv) reduced the risk of event-free survival (EFS) events by 47% and reduced the risk of death by 35% when given before and after surgery versus neoadjuvant chemotherapy and surgery in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. These late-breaking data will. ...

Core Insights - Merck and Mayo Clinic have announced a strategic collaboration to leverage AI and advanced analytics for drug discovery and precision medicine, integrating Mayo Clinic's clinical insights and genomic data with Merck's AI capabilities [1] Collaboration Details - The partnership will utilize Mayo Clinic's Platform architecture and multimodal clinical data to enhance disease understanding and improve target identification for drug development [1] - This collaboration marks Mayo Clinic's first strategic partnership of this scale with a global biopharmaceutical company [1] Focus Areas - The initial focus will be on three therapeutic areas: - Neurology: Multiple sclerosis - Dermatology: Atopic dermatitis - Gastroenterology: Inflammatory bowel disease (IBD) [1] Technology Integration - Merck will access Mayo Clinic's de-identified clinical data, including laboratory results, medical imaging, clinical notes, and molecular data, to validate AI models and translate research insights into actionable strategies [1] - The collaboration aims to speed up the development of innovative therapies by combining clinical expertise with advanced AI tools [1] Company Background - Merck, known as MSD outside the U.S. and Canada, has a long history of developing important medicines and vaccines, aspiring to be a premier research-intensive biopharmaceutical company [1] - Mayo Clinic is a nonprofit organization focused on innovation in clinical practice, education, and research, committed to providing compassionate care [1]

Core Viewpoint - Merck has received FDA approval for KEYTRUDA® and KEYTRUDA QLEX™ for treating adults with PD-L1+ platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [1] Group 1: Product Approval - The FDA approved KEYTRUDA® (pembrolizumab) for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] 1) [1] - KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, is also approved for the same indication [1]

Core Viewpoint - Agilent Technologies Inc. has received FDA approval for PD-L1 IHC 22C3 pharmDx as the only FDA-approved companion diagnostic for identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 and may be eligible for treatment with KEYTRUDA® [1] Group 1 - The FDA has approved PD-L1 IHC 22C3 pharmDx as a companion diagnostic [1] - This diagnostic is specifically indicated for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma [1] - The approval aids in identifying patients whose tumors express PD-L1 and who may be eligible for KEYTRUDA® treatment [1]

Core Insights - Merck announced positive topline results from the Phase 3 KEYNOTE-B15 trial for patients with muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy [1] - The trial evaluated the combination of KEYTRUDA® (pembrolizumab) and Padcev® (enfortumab vedotin-ejfv) as neoadjuvant and adjuvant treatment, showing statistically significant results [1] Company Summary - Merck, known as MSD outside the United States and Canada, is focusing on innovative cancer treatments [1] - The positive results from the KEYNOTE-B15 trial may enhance Merck's position in the oncology market [1] Industry Summary - The trial results contribute to the growing body of evidence supporting immunotherapy and targeted therapy combinations in treating bladder cancer [1] - The findings may influence treatment protocols and patient outcomes in the field of oncology [1]

Core Insights - The FDA has granted Fast Track Designation to Adagene's muzastotug in combination with Merck's KEYTRUDA® for treating adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) without active liver metastases, highlighting the potential of this therapy to meet an unmet medical need [1][2][3] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence to create innovative therapies [4][7] - The company employs its proprietary SAFEbody technology to enhance the safety and efficacy of antibody therapies by targeting the tumor microenvironment while minimizing systemic toxicity [6][7] Clinical Development - Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody designed to overcome Treg resistance in tumors, showing promising efficacy and safety in heavily pretreated patient populations [2][3] - The ongoing Phase 2 trial will evaluate muzastotug in combination with pembrolizumab, with a focus on late-line patients with MSS CRC without liver metastases [5][7] - The primary endpoint for the Phase 2 trial is overall response rate (ORR), while the Phase 3 trial will focus on overall survival (OS) as the primary endpoint [5] Future Plans - Adagene plans to share updated topline Phase 1b/2 clinical data in the coming months and is preparing for a registration trial set to begin in 2027 [3][5]

Company Presentation & KOL Webinar MDNA11 Clinical Data Update 10 December 2025 ESMO-IO Congress 2025 Disclaimer Certain statements in this presentation may constitute "forward-looking statements" under applicable securities laws. These forward-looking statements include, but are not limited to, information about possible or assumed future results of the Medicenna Therapeutics Corp's (the "Company" or "Medicenna") business, clinical trials, drug development, financial condition, results of operations, liqui ...

Core Points - Merck will participate in the 8th Annual Evercore ISI HealthCONx Conference on December 2, 2025, featuring Chirfi Guindo and Dr. Eliav Barr [1] - A live audio webcast of the presentation will be available for investors, analysts, and the public [2] - Merck aims to be a leading research-intensive biopharmaceutical company, focusing on innovative health solutions and a diverse workforce [3] Company Overview - Merck, known as MSD outside the U.S. and Canada, has over 130 years of experience in developing important medicines and vaccines [3] - The company is committed to advancing clinical research in hematology and has an expanding pipeline of investigational candidates [7]

Core Viewpoint - Merck has received FDA approval for KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for the treatment of muscle-invasive bladder cancer in adult patients [1] Group 1 - The FDA approved KEYTRUDA (pembrolizumab) as a neoadjuvant treatment and continued as adjuvant treatment after cystectomy for muscle-invasive bladder cancer [1] - KEYTRUDA QLEX, a combination of pembrolizumab and berahyaluronidase alfa-pmph, has also been approved for the same indication [1] - The treatment is specifically for adult patients diagnosed with muscle-invasive bladder cancer (MIBC) [1]