Pembrolizumab

The KEYNOTE-B96 Phase 3 trial demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) with KEYTRUDA plus chemotherapy with or without bevacizumab in platinum-resistant recurrent ovarian cancer. The study showed PFS benefits in the overall population and OS benefits in patients with PD-L1 expressing tumors. The FDA has granted priority review to Merck’s sBLA for this combination, with a PDUFA date of Feb. 20, 2026, potentially changing treatment for this challenging disease.

Merck’s KEYNOTE-905 (EV-303) trial showed positive results for muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin-based chemotherapy. The study combined KEYTRUDA (pembrolizumab) and Padcev (enfortumab vedotin-ejfv) before and after surgery, demonstrating statistically significant and clinically meaningful improvement in event-free survival (EFS), overall survival (OS), and pathologic complete response (pCR) compared to surgery alone. This represents the first systemic therapy to improve survival in this population, potentially establishing a new standard of care. The treatment’s safety profile was consistent with existing data.