Enfortumab Vedotin Plus Pembrolizumab in Untreated Locally Advanced or Metastatic Urothelial Carcinoma: 2.5-Year Median Follow-Up of the Phase III EV-302/KEYNOTE-A39 Trial.

Background: At the primary analysis of the EV-302 trial, enfortumab vedotin plus pembrolizumab (EV+P) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared with chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).

Methods: Here, we report an updated analysis of efficacy and safety in the overall population, with a median follow-up of 2.5 years, providing an additional year of follow-up since the primary analysis.

Results: Median PFS by blinded independent central review was 12.5 months (95% CI, 10.4-16.6) for the EV+P arm and 6.3 months (95% CI, 6.2- 6.5) for the chemotherapy arm (HR, 0.48 [95% CI, 0.41-0.57]). Median OS was 33.8 months (95% CI, 26.1-39.3) for the EV+P arm and 15.9 months (95% CI, 13.6-18.3) for the chemotherapy arm (HR, 0.51 [95% CI, 0.43-0.61]). Safety data with an additional year of follow-up were consistent with those of the primary analysis.

Conclusions: The continued survival benefit with EV+P compared with chemotherapy at this updated analysis reinforce EV+P as the standard of care for the first-line treatment of patients with la/mUC.