Seagen and Astellas Report P-III Trial (EV-302) Results of Padcev (enfortumab vedotin-ejfv) and Keytruda for Advanced Bladder Cancer
Shots:
- The P-III trial (EV-302/KEYNOTE-A39) evaluating enfortumab vedotin + pembrolizumab vs CT in patients with previously untreated LA/mUC who were eligible for cisplatin- or carboplatin-containing CT regardless of PD-L1 status
- The study met its dual 1EPs of OS and PFS while an IDMC determined that OS crossed the pre-specified efficacy boundary at interim analysis. The safety results were consistent with those of enfortumab vedotin + pembrolizumab
- Padcev + Keytruda received accelerated approval from the US FDA in April 2023 for adult patients with la/mUC who are not eligible to receive cisplatin-containing CT, based on the (EV-103) trial results
Ref: Businesswire | Image: Seagen
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