Seagen Inc. and Astellas Pharma Inc. have announced encouraging results from the Phase 3 EV-302 clinical trial, presenting PADCEV in combination with KEYTRUDA versus chemotherapy. This potent combination significantly improved overall survival (OS) and progression-free survival (PFS) for patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

Highlighted Findings from the EV-302 Study

The comprehensive data from the Phase 3 EV-302 clinical trial met its dual primary endpoints when contrasted with platinum and gemcitabine chemotherapy. Specifically:

• A remarkable median OS of 31.5 months for those treated with enfortumab vedotin and pembrolizumab. This is a stark contrast to the 16.1 months observed in the chemotherapy arm.
• A significant 53% reduced risk of death when compared to chemotherapy treatment.
• Median PFS saw an improvement to 12.5 months compared to 6.3 months in chemotherapy.

Furthermore, the most commonly observed Grade 3 or higher adverse events in the Phase 3 EV-302 clinical trial were found to be consistent with previous reports. No new safety concerns arose during the study.

Expert Opinions on the Breakthrough

Roger Dansey, President, Research and Development at Seagen, emphasized the potential shift in treating metastatic urothelial cancer, stating, “The combination of enfortumab vedotin and pembrolizumab, if approved, represents a potential paradigm shift in the treatment of metastatic urothelial cancer. The results of this historic trial presented today show improvements in overall survival and progression free survival not previously achieved in a broad population of patients.”

Concurring with this sentiment, Ahsan Arozullah, Senior Vice President, Head of Oncology Development at Astellas, highlighted the potential of longer survival and minimized disease progression for patients.

Additional Insights from the Phase 3 EV-302 clinical trial

The secondary endpoints also showcased a promising 68% confirmed objective response rate in patients under the combined treatment of enfortumab vedotin and pembrolizumab. When compared to the 44% found in chemotherapy-treated patients, this demonstrates substantial progress.

The Phase 3 EV-302 clinical trial, an open-label, randomized, controlled study, focused on evaluating the combination in patients with previously untreated la/mUC. The results aim to form the basis for global submissions and the confirmatory trial for U.S. accelerated approval of this potent combination.

  Ahsan Arozullah, Astellas, Keytruda, PADCEV, Roger Dansey, Seagen, urothelial cancer, USA