Trial Results
Merck announced positive topline results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, for patients with muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy. The trial demonstrated that KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv), used as neoadjuvant and adjuvant treatments, significantly improved event-free survival, overall survival, and pathologic complete response rates compared to neoadjuvant chemotherapy and surgery alone.
Study Collaboration
The trial was conducted in collaboration with Pfizer and Astellas, building on the clinical success of this combination in locally advanced or metastatic urothelial cancer and cisplatin-ineligible MIBC. The safety profile of the combination was consistent with known profiles, with no new safety signals identified.
Regulatory Plans
Merck plans to share these results with regulatory authorities worldwide for potential filings and will present the data at an upcoming medical meeting. KEYTRUDA plus Padcev is already approved for certain bladder cancer treatments in the U.S., EU, Japan, and other countries.
Ongoing Research
Three additional Phase 3 studies are evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive, and metastatic. These studies include KEYNOTE-866 and KEYNOTE-992 for MIBC, and KEYNOTE-676 for non-muscle-invasive bladder cancer in combination with Bacillus Calmette-Guerin (BCG).
