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ASCO 2023: Long-Term Update on Use of Enfortumab Vedotin Plus Pembrolizumab in Advanced Urothelial Carcinoma

By: Jenna Carter, PhD
Posted: Wednesday, June 7, 2023

Updated safety, efficacy, and survival data from the dose-escalation/cohort A of Study EV-103, which assessed the combination of the monoclonal antibody enfortumab vedotin-ejfv and the PD-1 inhibitor pembrolizumab in the first-line treatment of cisplatin-ineligible, locally advanced or metastatic urothelial carcinoma, were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4505).With nearly 4 years of follow-up, Shilpa Gupta, MD, of the Cleveland Clinic, said the combination therapy continued to show “promising survival trends with rapid and durable responses.”

“These the evaluation of enfortumab vedotin and pembrolizumab in ongoing phase III studies in urothelial carcinoma,” stated the investigators.

Overall findings revealed a median progression-free survival of 12.7 months and a 12-month progression-free survival rate of 55.0%. The median overall survival was 26.1 months, and the 12-month overall survival rate was 83.4%. After a median of nine cycles, the confirmed overall response rate by blinded independent central review was 73.3% (confidence interval [CI] = 58.1%–85.4%); the disease control rate was 84.4% (95% CI = 70.5%–93.5%), and the complete response rate was 15.6%. As for the median duration of response, it was 22.1 months, with a 12-month duration of response rate of 63.9%.

Safety analyses revealed that the most common treatment-related adverse events with enfortumab vedotin were skin reactions (66.7%), peripheral neuropathy (62.2%), and ocular disorders (40.0%). The most common adverse events reported with pembrolizumab were severe skin reactions (24.4%), pneumonitis (8.9%), colitis (6.7%), and hypothyroidism (6.7%).

A total of 45 patients with locally advanced or metastatic urothelial cancer were included in this ongoing phase Ib/II study. Patients received 3-week cycles of 1.25 mg/kg (days 1–8) of enfortumab vedotin in combination with pembrolizumab (day 1).

Disclosure: For full disclosures of the study authors visit

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