Wedoany.com Report-Nov. 28, The US Food and Drug Administration has approved two regimens combining Merck’s Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) with Astellas/Pfizer’s Padcev (enfortumab vedotin-ejfv) as perioperative treatment for adults with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin-based chemotherapy.

The approvals mark the first PD-1 inhibitor plus antibody-drug conjugate combinations for this indication. Patients receive the combination before and after radical cystectomy.

Approval is based on the Phase III Keynote-905/EV-303 trial. After median follow-up of 25.6 months, the regimen reduced the risk of event-free survival events by 60 percent and overall survival risk by 50 percent compared with surgery alone. Pathologic complete response rates reached 57.1 percent versus 8.6 percent with surgery only.

Keytruda Qlex is contraindicated in patients with hypersensitivity to berahyaluronidase alfa, hyaluronidase, or related excipients.

Dr Matthew Galsky, Lillian and Howard Stratton Professor of Medicine at Mount Sinai Tisch Cancer Center and Keynote-905 investigator, said: “Pembrolizumab plus enfortumab vedotin is poised to address a critical unmet need. Half of patients with MIBC may experience cancer recurrence even after having their bladder removed, and many of these patients are ineligible to receive cisplatin.”

Dr Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said: “We are honoured to provide these patients who previously had only one option – surgery – with a choice to receive their immunotherapy either intravenously or subcutaneously.”

The approvals offer a new standard-of-care option for cisplatin-ineligible MIBC patients, providing both intravenous and subcutaneous administration routes for the PD-1 inhibitor component.