Dr Bilusic on Key Trials That Inform the Treatment of Patients With Urothelial Carcinoma

Marijo Bilusic, MD, PhD, medical oncologist, Genitourinary Medical Oncology, University of Miami Health System, Sylvester Comprehensive Cancer Center, discusses key trials in the treatment armamentarium for patients with urothelial carcinoma, as presented at the 2023 Sylvester Annual Oncology Updates Meeting.

Bilusic presented on the topic of the phase 1/2 EV-103/KEYNOTE-869 study (NCT03288545),which evaluated enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) in cisplatin-ineligable patients with locally advanced or metastatic urothelial carcinoma. Based on the findings from this study, in April 2023, the FDA granted approval to this treatment for use in the frontline setting in this patient population. Notably, this approval marks a significant shift in how oncologists approach the treatment of patients with metastatic urothelial cancer, particularly in the frontline setting, Bilusic emphasizes. 

Another topic addressed at the meeting was the SWOG S1011 study (NCT01224665), which delved into surgical considerations, evaluating standard or extended pelvic lymphadenectomyin the treatment of patients undergoing surgery for invasive bladder cancer. This topic is significant for patients, who often inquire about the necessity of lymph node removal, Bilusic emphasizes. One crucial takeaway from this trial, findings from which were presented in 2023, is that extensive lymphadenectomies are not imperative, he states. Adhering to the standard node removal procedure yields survival outcomes equivalent to those achieved with extensive pelvic lymphadenectomies and is less morbid, Bilusic explains. This study offers valuable insights into optimizing surgical procedures for patients who have undergone chemotherapy, he notes.

Bilusic continues that the final aspect of the discussion centered on the treatment sequence for managing urothelial carcinoma. Although enfortumab vedotin plus pembrolizumab is not yet FDA approved for cisplatin-eligible patients, data to support the use of this combination in this population may be presented at upcoming medical meetings, he explains. Bilusic anticipates that this potential approval will reconfigure treatment approaches in urothelial cancer and may position the combination as the most frequently prescribed frontline therapy for patients with urothelial cancer, he concludes.