FDA Grants Priority Review to Enfortumab Vedotin for Metastatic Urothelial Cancer

The FDA accepted the biologics license application (BLA) filing for the investigational agent enfortumab vedotin and granted a priority review for the agent to treat patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Enfortumab vedotin is a novel investigational antibody-drug conjugate that targets Nectin-4, a protein highly expressed in patients with urothelial cancers¹, and was originally granted a breakthrough therapy designation in March 2018 for this patient population.

Andrew Krivoshik, MD, PhD, senior vice president and oncology therapeutic area head at Astellas, one of the manufacturers of the agent, commented on the BLA filing saying, “If approved, enfortumab vedotin will likely play an important role in the treatment of advanced urothelial cancer, and we look forward to working with the FDA as the review process advances.”

The agency’s acceptance of the BLA filing is based on findings from the EV-201 pivotal phase II clinical trial of enfortumab vedotin presented at the 2019 American Society of Clinical Oncology (ASCO) annual meeting.

At the 2019 ASCO annual meeting OncLive^®, a sister publication of Oncology Nursing News^®, was able to discuss with Daniel P. Petrylak, MD, professor of medicine and urology at Yale Cancer Center, the findings derived from 128 patients in the first cohort of this study, which was used as the basis for the BLA finding. “What we found was a 44% [overall response rate (ORR)] with a 38% response in the liver, and 12% of patients had a complete response,” he said, adding that only 12% of patients involved in the study discontinued due to adverse events, which included fatigue, diabetes, peripheral neuropathy, and rash. The safety and efficacy of enfortumab vedotin still remain under investigation.

For patients diagnosed with bladder cancer, urothelial cancer is the most common type of the disease and, according to Petrylak, 18,000 patients will die from it this year alone. This is why Roger Dansey, MD., chief medical officer at Seattle Genetics, called the FDA’s acceptance of their BLA filing “a significant milestone toward offering a new treatment to patients with advanced urothelial cancer who have a clear unmet need.”

Cohort 2 of the EV-201 study continues to actively recruit patients for the study while a phase 3 trial looking at enfortumab vedotin versus platinum-based chemotherapy in patients with metastatic urothelial cancer is ongoing.

Reference

• A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4. BladderCancerJournal.com. https://bladdercancerjournal.com/study-escalating-doses-asg-22ce-given-monotherapy-subjects-metastatic-urothelial-cancer-and-other. Published 2019. Accessed September 16, 2019.