Merck announces topline results from KEYNOTE-905 trial

Merck (MRK) announced topline results from the Phase 3 KEYNOTE-905 trial in patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. In this study, Keytruda plus Padcev, given before and after surgery, demonstrated a statistically significant and clinically meaningful improvement in event-free survival, the study’s primary endpoint, as well as overall survival and pathologic complete response rate, key secondary endpoints, compared to surgery alone. The trial, evaluating Merck’s Keytruda, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate, was conducted in collaboration with Pfizer (PFE) and Astellas (ALPMY) and builds on the clinical success of this combination in locally advanced or metastatic urothelial cancer. The trial is continuing to evaluate the secondary EFS, OS, and pCR rate endpoints for neoadjuvant and adjuvant Keytruda versus surgery alone as they continue to mature. The safety profile of Keytruda plus Padcev in this study was consistent with the known safety profiles of each agent. No new safety signals were identified with the combination. The companies plan to share these results with regulatory authorities worldwide and will present the data at an upcoming medical meeting. Keytruda plus Padcev is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer in the U.S., the European Union, Japan and several other countries around the world.