Guru P. Sonpavde, MD, discusses the importance of utilizing precision medicine in bladder cancer, and highlights the rationales and designs of the ongoing phase 3 EV-302 and AMBASSADOR trials.
Guru P. Sonpavde, MD, medical director, Genitourinary (GU) Oncology, assistant director, the Clinical Research Unit, the Christopher K. Glanz Chair, Bladder Cancer Research, AdventHealth Cancer Institute, discusses the importance of utilizing precision medicine in bladder cancer, and highlights the rationales and designs of theongoing phase 3 EV-302 (NCT04223856) and AMBASSADOR (NCT03244384) trials.
The urothelial cancer treatment landscape lacks clarification about the biology of the disease, Sonpavde begins. Therefore, precision medicine will become more important in the treatment of bladder cancer, he adds. Several agents are now available to treat this patient population, increasing the importance of selecting the optimaltreatment for each patient, Sonpavde explains. This evolving landscape continues to bring precision medicine to the forefront of treating oncologists’ minds, he says. Additionally, evaluating novel, tolerable treatmentcombinations for patients with bladder cancer is an important area of investigation, he adds.
The combination of enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) is now FDA approved in the United States as a first-line therapy for cisplatin-ineligible disease, Sonpavde expands. This April 2023 FDA approval is based on data from the combined dose-escalation/cohort A and cohort K of the phase 1/2 EV-103/KEYNOTE-869 study (NCT03288545). Notably, updated data from the dose-escalation cohort and cohort A were presented at the 2023 ASCO Annual Meeting. Now, clinicians await the results of the phase 3 EV-302 trial, which is comparing the use of enfortumab vedotin with pembrolizumab vs gemcitabine plus platinum chemotherapy in all comers with previously untreated locally advanced or metastatic urothelial cancer, Sonpavde emphasizes. These trials are likely to expand the bladder cancer treatment landscape, Sonpavde adds.
Moreover, the results of adjuvant and neoadjuvant trials are continually awaited, he continues. Specifically, adjuvant nivolumab (Opdivo) is FDA approved for patients with high-risk urothelial carcinoma, and findings from the phase 3 AMBASSADOR trial, which is investigating adjuvant pembrolizumab in high-risk, muscle-invasive urothelial carcinoma, are eagerly awaited, Sonpavde concludes.