The U.S. Food and Drug Administration has approved pembrolizumab (Keytruda) and its subcutaneous formulation, pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), in combination with enfortumab vedotin-ejfv (Padcev) as perioperative treatment for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
The approval is based on findings from the phase 3 KEYNOTE-905 (EV-303) trial conducted by Merck, Pfizer, and Astellas. The decision marks the first FDA authorization of a PD-1 inhibitor combined with an antibody-drug conjugate for this patient group.
Under the new indication, patients receive pembrolizumab or pembrolizumab Qlex plus enfortumab vedotin before surgery, followed by continued therapy after radical cystectomy.
After a median follow-up of 25.6 months, the regimen reduced the risk of event-free survival events by 60% compared with surgery alone. Overall survival improved by 50%. Pathologic complete response rates were 57.1% for the combination versus 8.6% for surgery alone.
Keytruda Qlex carries a contraindication for patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase, or any excipients.
Dr. Matthew Galsky of the Mount Sinai Tisch Cancer Center, an investigator on KEYNOTE-905, noted that many patients with MIBC face recurrence even after bladder removal, and a significant portion cannot receive cisplatin. “Pembrolizumab plus enfortumab vedotin is poised to address a critical unmet need,” he said.
Dr. Marjorie Green, senior vice president of oncology global clinical development at Merck Research Laboratories, said the approval offers patients an important choice. “These patients previously had only one option—surgery. Now they can receive immunotherapy intravenously or subcutaneously,” she said.
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