Enfortumab vedotin-ejfv (Padcev) elicited durable responses in patients with locally advanced or metastatic urothelial cancer who received previous treatment with a PD-1/PD-L1 inhibitor, have not been given a platinum-containing chemotherapy, and are not eligible for cisplatin, according to topline results from the second cohort of patients in the phase 2 EV-201 trial (NCT03219333).1

Results from the trial showed that the antibody-drug conjugate (ADC) resulted in an objective response rate (ORR) of 52% (95% CI, 40.8-62.4) via blinded independent central review (BICR), with a median duration of response (DOR) of 10.9 months. With regard to safety, the most commonly experienced adverse effects (AEs) that occurred in 5% of patients and were grade 3 or higher included neutropenia, rash, fatigue, increased lipase, diarrhea, decreased appetite, anemia, and hyperglycemia. Seagen, Inc and Astellas Pharma, Inc announced that the results from cohort 2 of EV-201 will be submitted for presentation at an upcoming medical meeting; the data will also be discussed with regulatory authorities.

“This is the first trial to report objective responses in patients with advanced urothelial cancer who had previously received immunotherapy but were ineligible for cisplatin in this setting due to inadequate kidney function or other conditions,” said Roger Dansey, MD, chief medical officer at Seagen, Inc.1 “These promising new data from EV-201 may support a regulatory application to extend use of [enfortumab vedotin] in US patients whose cancer has progressed after immunotherapy and who are ineligible for cisplatin.”

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