The U.S. Food and Drug Administration (FDA) has granted priority review to the supplemental Biologics License Applications for pembrolizumab (Keytruda) and pembrolizumab plus berahyaluronidase alfa (Keytruda Qlex), both in combination with enfortumab vedotin (Padcev), in patients with cisplatin-eligible muscle-invasive bladder cancer (MIBC). Merck shared news of the priority review in a recent press release.
If granted approval, these would represent the first and only perioperative treatment options combining an immunotherapy with an antibody-drug conjugate in MIBC, irrespective of eligibility for cisplatin.
Pembrolizumab is an immunotherapy that inhibits anti-programmed death receptor-1 (PD-1), helping the immune system to target and destroy cancer cells. Individuals may receive the drug on its own intravenously or with berahyaluronidase alfa as a subcutaneous injection. Enfortumab vedotin is an antibody-drug conjugate that binds to specific proteins on tumor cells, releasing cancer-killing drugs into the cells.
Priority review was based on findings from the Phase 3 KEYNOTE-B15 clinical trial, which Merck carried out in collaboration with Pfizer and Astellas. The study randomized 405 patients to receive enfortumab vedotin plus pembrolizumab and 403 to receive cisplatin plus gemcitabine. Participants taking enfortumab vedotin plus pembrolizumab experienced superior event-free survival, overall survival and pathological complete response rate.
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“Even with curative-intent surgery and chemotherapy, patients still experience disease progression or limited survival,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck. “Results from KEYNOTE-B15 challenge long-held expectations for patients with muscle-invasive bladder cancer.”
This combination therapy is currently approved in the United States for adults with MIBC who are not eligible for cisplatin-based treatment. The FDA has set a target deadline of August 17, 2026, to make a decision regarding approval for cisplatin-eligible populations.
Merck, Pfizer and Atellas also intend to submit findings from KEYNOTE-B15 to regulatory agencies globally.
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