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

Abstract

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).

Patients and methods: We present 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: The median PFS by blinded independent central review was 12.5 months [95% confidence interval (CI) 10.4-16.6 months] for the EV+P arm and 6.3 months (95% CI 6.2-6.5 months) for the chemotherapy arm [hazard ratio (HR) 0.48, 95% CI 0.41-0.57]. The median OS was 33.8 months (95% CI 26.1-39.3 months) for the EV+P arm and 15.9 months (95% CI 13.6-18.3 months) 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.

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

Keywords: EV-302; antibody-drug conjugate; enfortumab vedotin; overall survival; pembrolizumab; progression-free survival.