RAHWAY, N.J. — Merck has announced that its immunotherapy KEYTRUDA® (pembrolizumab) combined with Padcev® (enfortumab vedotin-ejfv) significantly improved event-free survival (EFS), overall survival (OS), and pathologic complete response (pCR) rates in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy, when used both before and after surgery.
The results, from the Phase 3 KEYNOTE-905 (EV-303) trial, mark the first time a systemic therapy has extended survival in this patient group when given in the perioperative setting, representing what researchers call a major advancement for MIBC care.
“Patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy have not seen any treatment advance beyond surgery,” said Dr. Christof Vulsteke, principal investigator of KEYNOTE-905. “This combination significantly extended survival over standard-of-care surgery, addressing a critical unmet need.”
KEYNOTE-905 compared surgery alone to surgery combined with KEYTRUDA and Padcev in cisplatin-ineligible patients. In the main comparison, the combination therapy was given before surgery (three cycles) and after surgery (six cycles with both drugs, followed by eight cycles of KEYTRUDA alone). Patients receiving the combination showed statistically significant and clinically meaningful gains in survival and response compared to surgery alone.
The safety profile of the combination was consistent with known side effects for each drug, and no new safety signals emerged. Merck said it will share the findings with global regulatory authorities and present full data at an upcoming medical meeting.
“There is a pressing need for more effective options for bladder cancer patients who can’t receive cisplatin,” said Dr. Marjorie Green, senior vice president at Merck Research Laboratories. “These results reinforce the potential of pairing an anti-PD-1 therapy with an antibody-drug conjugate to improve outcomes.”
KEYTRUDA and Padcev are already approved together for certain patients with locally advanced or metastatic urothelial cancer. The combination is also being evaluated in multiple other Phase 3 bladder cancer trials, including in earlier stages of disease.
