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Enfortumab Vedotin-ejfv Under Study in Cisplatin-Ineligible Urothelial Carcinoma

By: Vanessa A. Carter, BS
Posted: Tuesday, September 7, 2021

Arjun V. Balar, MD, of the Perlmutter Cancer Center, NYU Langone Health, New York, and colleagues investigated the safety and efficacy of enfortumab vedotin-ejfv—an antibody-drug conjugate targeting Nectin-4, a protein highly expressed in urothelial carcinoma—in patients with urothelial carcinoma who previously received immunotherapy. Published in The Lancet Oncology, these researchers suggested this treatment may be a “promising new therapy,” as they observed a confirmed response in 52% of individuals who were ineligible for cisplatin.

The phase II EV-201 focused on 89 patients with locally advanced or metastatic urothelial carcinoma. The dose was 1.25 mg/kg of enfortumab vedotin on days 1, 8, and 15 of each 28-day cycle, with no cycle limit. Participants had a cisplatin-ineligible disease and were required to have been previously treated with a PD-L1 or PD-1 inhibitor.

The median follow-up was 13.4 months, with a median duration of response of 1.8 months. A complete response was observed in 18 patients; 28 achieved a partial response, and 27 reached stable disease. By data cutoff, 56 events of disease progression or death were reported, yielding a progression-free survival of 5.8 months; the 6- and 12-month estimated progression-free survival rates were 50% and 33%, respectively. The median overall survival was 14.7 months.

More than half of patients experienced treatment-related adverse events of grade 3 or higher, with the most common being neutropenia, maculopapular rash, and fatigue; 15 patients experienced serious treatment-related adverse events. Dose reductions in 41 patients were attributed to adverse events, mostly due to peripheral sensory neuropathy. Within 30 days of the first dose, three patients died of metabolic acidosis, multiple organ dysfunction, and acute kidney injury, respectively; one death from pneumonitis was recorded 30 days after the patient’s final dose. 

Disclosure: For full disclosures of the study authors, visit thelancet.com.



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