Seagen Inc SGEN and Astellas Pharma Inc ALPMF ALPMY released topline results from the KEYNOTE-A39 Phase 3 EV-302 trial for Padcev (enfortumab vedotin-ejfv) combined with Merck & Co Inc MRK Keytruda (pembrolizumab) versus chemotherapy in bladder cancer.
The trial included patients with previously untreated locally advanced or metastatic urothelial cancer, a form of bladder cancer that has spread to surrounding organs, muscles, or other body parts.
The EV-302 trial enrolled patients with previously untreated patients eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.
The EV-302 study met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy.
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An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis.
The safety results of the combination are consistent with those of enfortumab vedotin in combination with pembrolizumab previously reported in cisplatin-ineligible patients.
The Phase 3 KEYNOTE-A39 trial is intended to serve as the confirmatory trial for the current U.S. accelerated approval of Keytruda in combination with enfortumab vedotin as first-line treatment for urothelial carcinoma who are not eligible to receive cisplatin-containing chemotherapy.
Price Action: SGEN shares are up 3.54% at $213.69 on the last check Friday.
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