Bladder Cancer Coverage from Every Angle

Update From EV-103: Enfortumab Vedotin-ejfv Plus Pembrolizumab for Advanced Urothelial Carcinoma

By: Julia Fiederlein
Posted: Thursday, July 29, 2021

After the presentation of preliminary data from the multicohort EV-103 trial, in February 2020, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to enfortumab vedotin-ejfv plus pembrolizumab for the first-line treatment of patients with cisplatin-ineligible locally advanced or metastatic urothelial carcinoma. The updated long-term follow-up data, which were presented by Terence W. Friedlander, MD, of the University of California San Francisco Medical Center, and colleagues during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4528), further highlighted the activity, durable response profile, and manageable safety profile of this platinum-free regimen.

“Enfortumab vedotin is an antibody-drug conjugate delivering the microtubule-disrupting agent monomethyl auristatin E to targeted tumor cells expressing Nectin-4,” the investigators commented. “Clinical data suggest the combination of enfortumab vedotin plus pembrolizumab may have the potential to induce greater antitumor activity compared with either agent alone.”

This report focused on 45 patients who were treated with 3-week cycles of enfortumab vedotin plus pembrolizumab. Follow-up data were provided for a median of 24.9 months. Peripheral sensory neuropathy (56%), fatigue (51%), and alopecia (49%) were among the most frequently reported treatment-related adverse events. Per investigator assessment, one death was reported as possibly related to the study treatment. The longer follow-up did not reveal any new safety signals.  

The confirmed objective response rate was 73.3%; this included 17.8% of patients with a complete response. In patients with liver metastasis, the objective response rate was 57.1%. The median duration of response was 25.6 months. Of the responders, 53% had a duration of response of 24 months. The disease control rate and median duration of progression-free survival were 93.3% and 12.3 months, respectively. The median duration of overall survival was not reached. At 24 months, the overall survival rate was 56.3%.

Disclosure: For full disclosures of the study authors, visit

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