Merck confirms Phase 3 KEYNOTE-A39/EV-302 trial met dual primary endpoints

Merck (MRK) announced positive topline results from the Phase 3 KEYNOTE-A39 trial, which was conducted in collaboration with Seagen (SGEN) and Astellas (ALPMY), evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma. The trial enrolled patients who may or may not be eligible for treatment with cisplatin-based chemotherapy, regardless of PD-L1 status. In the trial, KEYTRUDA in combination with enfortumab vedotin met its dual primary endpoints of overall survival and progression-free survival, demonstrating a statistically significant and clinically meaningful improvement versus chemotherapy in patients with previously untreated la/mUC. The combination also showed a statistically significant improvement in overall response rate, a key secondary endpoint, versus chemotherapy. The safety profile of KEYTRUDA and enfortumab vedotin in this study was consistent with previously reported studies of this combination.