FDA Approval Insights: Enfortumab Vedotin Plus Pembrolizumab in Locally Advanced/Metastatic Urothelial Carcinoma

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Seagen, we had the pleasure of speaking with Matthew Galsky, MD, about the FDA approval of enfortumab vedotin-ejvf (Padcev) plus pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer. Dr Galsky is a professor of medicine (Hematology and Medical Oncology) and director of Genitourinary Medical Oncology at the Icahn School of Medicine at Mount Sinai, as well codirector of the Center of Excellence for Bladder Cancer and associate director for Translational Research at The Tisch Cancer Institute in New York, New York.

On December 15, 2023, the FDA approved the combination of enfortumab vedotin and pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer. This regulatory decision was supported by findings from the phase 3 EV-302/KEYNOTE-A39 trial (NCT04223856) and follows the April 2023 FDA accelerated approval of the combination for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. In EV-302, enfortumab vedotin plus pembrolizumab produced a median overall survival of 31.5 months (95% CI, 25.4-not estimable) vs 16.1 months (95% CI, 13.9-18.3) with platinum-based chemotherapy (HR, 0.47; 95% CI, 0.38-0.58; P < .0001).

In our exclusive interview, Dr Galsky discussed the significance of this approval, key efficacy and safety data from the EV-302 trial, and future directions in urothelial cancer research.

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