Dr Sonpavde on an Exploratory Analysis of CheckMate 901 in Metastatic Urothelial Cancer

Guru P. Sonpavde, MD, medical director, Genitourinary (GU) Oncology, assistant director, Clinical Research Unit, Christopher K. Glanz Chair for Bladder Cancer Research, AdventHealth Cancer Institute, discusses topline data from an exploratory analysis of quality of life (QOL) outcomes in the phase 3 CheckMate 901 trial (NCT03036098) inpatients with metastatic urothelial cancer.

The CheckMate 901 trial provided significant insights into the efficacy of combining cisplatin/gemcitabine with nivolumab (Opdivo) for the first-line treatment of patients with urothelial cancer, Sonpavde begins. This randomized trial evaluated cisplatin/gemcitabine alone vs the combination of cisplatin/gemcitabine and nivolumab in patients who were eligible for cisplatin-based therapy, he explains. The trial yielded positive results with the addition of nivolumab to chemotherapy, showing a notable improvement in overall survival (HR, 0.78, 95% CI, 0.63-0.96; P = .02) and a progression-free survival improvement (HR, 0.72; 95% CI, 0.59- 0.88; P = .001), he reports. A key finding was the significant increase in the complete response (CR) rate, which nearly doubled from 11.8% in the chemotherapy-only arm to 21.7% in the group receiving nivolumab plus chemotherapy, according to Sonpavde. Importantly, the median duration of CR with the combination therapy was a remarkable 37.1 months (95% CI, 18.1-not evaluable), underscoring the durability of this response, Sonpavde states.

Further data revealed that patients with lymph node–only disease, representing 18% of patients in the nivolumab treatment arm, experienced even more pronounced benefits with the nivolumab combination, he continues. In the nivolumab arm, the CR rate in this subgroup was an impressive 63.0%, indicating that cisplatin/gemcitabine plus nivolumab holds significant promise for these patients, Sonpavde notes. He adds that this high CR rate indicates that the combination therapy should be strongly considered for those with lymph node–only disease.

These findings are particularly relevant in the context of other FDA-approved first-line treatments for patients with bladder cancer, such as enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda), which is approved for all-comers, he expands. The durability of response and the enriched CR rate in specific patient populations make cisplatin/gemcitabine plus nivolumab a compelling treatment consideration for urothelial cancer, Sonpavde concludes.