The US Food and Drug Administration has approved a new treatment option for adults with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin-based chemotherapy.
Merck announced that KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab plus berahyaluronidase alfa-pmph), used together with Padcev (enfortumab vedotin-ejfv), are now cleared for use before and after surgery. This marks the first approved combination of a PD-1 inhibitor with an antibody-drug conjugate for this patient group.
The approval addresses a major gap in care. Many people with MIBC are unable to take cisplatin, leaving them with limited treatment options. Merck, known as MSD outside North America, said this decision offers an important new path for these patients.
The FDA’s move is based on results from the Phase 3 KEYNOTE-905 (EV-303) trial, run in partnership with Pfizer and Astellas. In the study, patients who received the KEYTRUDA–Padcev combination had a 60% lower risk of event-free survival events compared with surgery alone. They also lived longer, with a 50% improvement in overall survival. In addition, 57% of treated patients achieved a complete pathologic response, compared with only 9% of those treated with surgery alone.
“These approvals could change daily practice for many patients,” said Dr. Matthew Galsky of the Mount Sinai Tisch Cancer Center, a principal investigator for the trial. “Half of people with MIBC experience cancer returning even after bladder removal. Many cannot receive cisplatin. This therapy gives new hope.”
Merck noted that patients can receive immunotherapy either intravenously or subcutaneously, giving doctors more flexibility. “Our goal is to bring meaningful innovations to patients,” said Dr. Marjorie Green, senior vice president at Merck Research Laboratories. “We are proud to introduce new options that may save lives.”
However, both KEYTRUDA and KEYTRUDA QLEX can cause serious immune-related side effects that may involve several organs. Severe or fatal infusion reactions may also occur. The drugs may harm a fetus if used during pregnancy. Patients must be monitored closely, and corticosteroids should be used when needed.
The Phase 3 trial enrolled 344 cisplatin-ineligible patients with MIBC. It compared perioperative KEYTRUDA, with or without Padcev, to surgery alone. Participants received three cycles of treatment before surgery, followed by up to 14 cycles of KEYTRUDA and six cycles of Padcev after surgery.
With this approval, the combination of KEYTRUDA and Padcev is expected to become a new standard of care for cisplatin-ineligible MIBC patients. It offers improved survival and a long-awaited treatment advance for a group that has seen little innovation for decades.
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