Dr. Gupta on 4-year data for enfortumab vedotin/pembrolizumab in urothelial carcinoma


Shilpa Gupta, MD, discusses long-term outcomes of the EV-103 trial, which explored the first-line combination of enfortumab vedotin and pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.

Shilpa Gupta, MD, director of genitourinary medical oncology at Taussig Cancer Institute and co-leader of the Genitourinary Oncology Program at Cleveland Clinic, discusses the abstract, “Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up,” which she presented at the 2023 ASCO Annual Meeting (4505).


This is the dose-escalation and cohort A populations of the EV-103 phase 1b study evaluating enfortumab vedotin and pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. Also, this for treatment-naive patients. Patients received enfortumab vedotin on days 1 and 8 and pembrolizumab every 21 days. The primary end point was safety and secondary end points included overall response rate, overall survival, and progression-free survival.

Previous results from this study have already led to the FDA approval of the combination in the setting. And now we are reporting 4-year follow-up data showing an objective response rate of around 73.3% by BICR which is highly concurrent with the investigator-assessed responses which were reported earlier. The median overall survival is exceeding two years at 26.1 months and the tail of the curve is still holding strong. The median progression-free survival is 12.7 months. Complete responses were 16%.

We did not see any new safety signals of the combination and I think these findings really show the durability of this combination and how effective it is. The ongoing phase 3 EV-302 study has completed accrual and is looking at the combination against chemotherapy will further lead to our understanding of whether it can surpass the chemotherapy.

Transcript has been edited for clarity.

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