MSD and Astellas announced positive Phase III results for Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin) in muscle-invasive bladder cancer (MIBC), showing statistically significant improvements in event-free survival versus surgery alone. The KEYNOTE-905 trial evaluated the Nectin-4 ADC plus PD-1 inhibitor as perioperative therapy in cisplatin-ineligible patients, with the combination arm also demonstrating meaningful overall survival and pathological complete response benefits. Safety profiles aligned with each drug's known effects.

The regimen builds on the partners' existing global approvals in metastatic urothelial cancer. MIBC accounts for 30% of bladder cancer cases globally, with limited options for cisplatin-ineligible patients. MSD and Astellas plan regulatory submissions based on these results, which could establish the first immunotherapy-ADC combination in this surgical setting. Detailed data will be presented at an upcoming medical conference.

PharmCube's NextBiopharm® database shows that MSD's Keytruda has entered over 2,000 trials in combination with other drugs globally. Click here to request a free trial for NextBiopharm®.