Adjusted EV-302 analysis reinforces survival advantage of EV/pembrolizumab

A simulated analysis of the EV-302 trial (NCT04223856) showed that the combination of enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) continued to demonstrate improved survival vs platinum-based chemotherapy in patients with locally advanced or metastatic urothelial carcinoma (la/mUC), even after adjusting for maintenance avelumab (Bavencio) utilization in the control arm.¹

The data were presented at the 2025 Society of Urology Oncology Annual Meeting in Phoenix, Arizona.

In a recent interview with Urology Times®, presenting author Fed Ghali, MD, discussed the background and implications from the analysis. Ghali is an assistant professor of urology at the Yale School of Medicine and a urologic oncologist at Yale Cancer Center in New Haven, Connecticut.

According to Ghali, this analysis addressed a common critique of the EV-302 trial, which established the combination as the first-line standard of care for patients with la/mUC. The combination received FDA approval in December 2023.

“Maintenance avelumab is a different immunotherapy which had previously been shown in another study called JAVALIN to improve survival,” Ghali explained. “The concern is that if the [control] arm is not given maintenance avelumab, then they don't perform as well as maybe they could have, and it can exaggerate the benefit that we see when you compare EV/P to that control arm. So, it's a fair critique.”

Overall, after accounting for maintenance avelumab use, the Kaplan-Meier curve showed an adjusted hazard ratio of 0.56 (CI, 0.46 to 0.70; P < .001).

“Hopefully [this will] provide reassurance to those who bring up this very fair critique,” Ghali concluded. “It tells us that even regardless of that [critique], EV/P is still a superior regimen and belongs where it rightfully is, which is in the front line.”

REFERENCE

1. Ghali F, Kandala K, Rahman SN, Jalfon M, James SL. Simulating outcomes of EV302 with use of maintenance avelumab in control arm patients. Presented at: Society of Urologic Oncology Annual Meeting; December 2-5, 2025; Phoenix, Arizona. Poster 36