Dr. Chatzkel on the Emergence of Novel Therapies in Metastatic Urothelial Cancer

Jonathan A. Chatzkel, MD, assistant professor of medicine, Division of Hematology and Oncology, University of Florida College of Medicine, University of Florida Health, discusses the emergence of novel therapies in relapsed/refractory locally advanced or metastatic urothelial cancer.

Novel therapies, including the antibody-drug conjugate (ADC) enfortumab vedotin-ejfv (Padcev), the ADC sacituzumab govitecan-hziy (Trodelvy), and the FGFR inhibitor erdafitinib (Balversa), have been welcome additions to the treatment of patients with metastatic urothelial carcinoma.

Enfortumab vedotin was initially granted accelerated approval by the FDA for use in patients with locally advanced or metastatic urothelial cancer who progressed on a PD-1/PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant, adjuvant, locally advanced, or metastatic settings. The accelerated approval was based on data from the phase 2 EV-201 trial (NCT03219333), which showed a 44% overall response rate with the agent. On July 9, 2021, the FDA granted a regular approval to the ADC based on confirmatory data from the phase 3 EV-301 trial (NCT03474107) and expanded the agent’s indication to include adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and who have received 1 or more prior lines of therapy.

Historically, treatment options were limited for patients with locally advanced or metastatic urothelial cancer who progressed on chemotherapy and immunotherapy, so the integration of these agents into the armamentarium has generated excitement in the field, Chatzkel concludes.