Merck Expands Keytruda Approvals and Announces AI Collaboration with Mayo Clinic
Merck secures regulatory approvals for Keytruda in ovarian cancer and subcutaneous formulation in Canada, while launching AI-driven drug discovery partnership with Mayo Clinic targeting high-need therapeutic areas.
The US FDA has approved Merck's Keytruda (pembrolizumab) for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, marking a significant expansion of the drug's application in oncology. Keytruda will be administered in conjunction with paclitaxel and optionally with Avastin (bevacizumab), aiming to enhance patient survival rates and progression-free survival in these cancer types.
The approval is based on the progression-free and overall survival results from the KEYNOTE-B96 trial, demonstrating Keytruda's efficacy in specific cancer patients. Additionally, the FDA approved Agilent Technologies' PD-L1 IHC 22C3 pharmDx companion diagnostic to identify patients who may benefit from Keytruda therapy, enhancing the precision and personalization of treatment options.
In a separate regulatory development, Health Canada has approved Keytruda SC, a new subcutaneous formulation of Merck's anti-PD-1 therapy pembrolizumab, offering an alternative to the current intravenous infusion. The decision to approve the new version is based on results from pivotal trial 3475A-D77, where the subcutaneous formulation was shown to deliver similar drug levels and effectiveness as the IV version when used with chemotherapy in certain lung-cancer patients.
The approval allows Merck to market the under-the-skin version of Keytruda in Canada, though the company said its rollout will depend on provincial and territorial reimbursement decisions.
Beyond regulatory approvals, Merck has signed a research and development agreement with Mayo Clinic to leverage artificial intelligence and multimodal clinical data to accelerate drug discovery and development, marking Mayo Clinic's first strategic collaboration of this scale with a global biopharmaceutical company.
By integrating Mayo Clinic's clinical and genomic datasets, Merck aims to enhance disease understanding and target identification using AI technologies, thereby improving the success rate of early development decisions and driving more effective personalized treatment options. The collaboration will initially target high-need therapeutic areas across three specialties, utilizing advanced analytics and multimodal approaches to advance the development of more effective therapies.
The CEO stated that by collaborating with Mayo Clinic, both parties will combine high-quality clinical data and AI insights to enhance the probability of success in drug development, ultimately accelerating the delivery of innovative therapies to patients.