Enfortumab Vedotin Plus Pembrolizumab Beats Chemotherapy for Survival Outcomes Among Patients With Untreated Advanced Urothelial Carcinoma
Results From the Phase 3 EV-302 Trial
Results From the Phase 3 EV-302 Trial
According to results from the EV-302 study, enfortumab vedotin plus pembrolizumab significantly improved progression-free survival (PFS) and overall survival (OS) among patients with untreated locally advanced or metastatic urothelial carcinoma, compared with the standard-of-care chemotherapy.
Thomas Powles, MD, Barts Cancer Institute Biomedical Research Center, London, UK, and coauthors wrote, “No treatment as surpassed platinum-based chemotherapy in improving overall survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma.
In this global, open-label, phase 3 trial, 886 patients were randomly assigned on a 1-to-1 basis to receive either enfortumab vedotin and pembrolizumab (experimental arm; n = 442), or gemcitabine plus either cisplatin or carboplatin (chemotherapy arm; n = 444). The primary end points of this study were PFS as assessed by a blinded independent central review, and OS.
With a median duration of follow-up of 17.2 months, the PFS was 12.5 months in the experimental arm vs 6.3 months in the chemotherapy arm (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.38 to 0.54; P < .001). The overall survival was 31.5 months vs 16.1 months respectively (HR, 0.47; 95% CI, 0.38 to 0.58; P < .001). Grade ≥3 treatment-related adverse events occurred in 55.9% of patients in the experimental arm and 69.5% in the chemotherapy arm.
Dr Powles et al concluded, “Treatment with enfortumab vedotin and pembrolizumab resulted in significantly better outcomes than chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma, with a safety profile consistent with that in previous reports.”
Source:
Powles T, Valderrama BP, Gupta S, et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med. Published online March 7, 2024. doi:10.1056/NEJMoa2312117
