Pfizer Inc. and Astellas Pharma Inc. have announced the FDA’s approval of PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) combined with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This approval marks the first combination treatment option to offer an alternative to the standard platinum-containing chemotherapy for first-line la/mUC.

The approval by the FDA was based on the groundbreaking results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39), which showed that the combination of PADCEV and pembrolizumab nearly doubled the median overall survival (OS) and median progression-free survival (PFS) in comparison to platinum-containing chemotherapy.

The trial’s findings, presented at the ESMO Congress 2023, also confirm the accelerated approval granted in April 2023 for using this combination in patients with la/mUC who are ineligible for cisplatin-containing chemotherapy. The label has now been expanded to include those eligible for cisplatin chemotherapy based on the results from EV-302.

Roger Dansey, M.D., Chief Development Officer, Oncology at Pfizer, noted the significant potential for the combination to transform the standard of care and extend the lives of patients with advanced bladder cancer. Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development at Astellas, emphasized the pivotal change this approval represents, offering new hope to patients and marking the first regimen to surpass the efficacy of platinum chemotherapy, which has been the gold standard for decades.

The EV-302 study achieved its dual primary endpoints of OS and PFS when comparing the combination treatment with chemotherapy. The combination treatment led to a median OS of 31.5 months versus 16.1 months for chemotherapy alone, a 53% reduction in the risk of death, and a median PFS of 12.5 months compared to 6.3 months with chemotherapy, a 55% reduction in the risk of cancer progression or death. Consistency in OS and PFS results across patient subgroups reinforces the robustness of these findings.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.