Enfortumab Vedotin-ejfv Shows Durable Responses in Locally Advanced or Metastatic Urothelial Cancer

Article

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.

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.”

Click to continue reading on OncLive.

Related Videos
Team of care workers with women at the center -- Image credit: Delmaine Donson/peopleimages.com | stock.adobe.com
Image Credit: SciePro - stock.adobe.com
Pharmacist selling medications in the pharmacy | Image Credit: rh2010 - stock.adobe.com
Atopic dermatitis on a patient's hand -- Image credit: Ольга Тернавская | stock.adobe.com
biosimilar word or concept represented by wooden letter tiles on a wooden table with glasses and a book | Image Credit: lexiconimages - stock.adobe.com
Image credit: alicja neumiler | stock.adobe.com
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.