CheckMate 901: Nivolumab Plus Gemcitabine, Cisplatin Versus Gemcitabine, Cisplatin Alone for mUC

A recent analysis of the CheckMate 901 trial from Guru P. Sonpavde, MD, and colleagues sought to determine the effects of nivolumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone for patients with previously untreated unresectable or metastatic urothelial carcinoma (mUC), including data from patients who responded to treatment.

The study was presented at the 2024 American Urological Association Annual Meeting.

In the phase 3, randomized CheckMate 901 trial, patients either underwent treatment every 3 weeks with nivolumab 360 mg plus gemcitabine and cisplatin for a maximum of 6 cycles followed by nivolumab 480 mg for 4 weeks until disease progression or unacceptable toxicity for up to 2 years, or they received gemcitabine and cisplatin every 3 weeks for up to 6 weeks.

The study’s primary end points included overall survival (OS) and progression-free survival (PFS) through blinded independent central review (BICR). Objective response rate (ORR) through BICR was a secondary end point.

After a median follow-up period of 33.6 months, researchers found that OS (hazard ratio [HR], 0.78; 95% CI, 0.63-0.96; P=.0171) and PFS (HR, 0.72; 95% CI, 0.59-0.88; P=.0012) showed increased benefits with nivolumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone.

In the combination treatment group, ORR was 57.6% and complete response (CR) was 21.7% versus 43.1% and 11.8%, respectively, in the gemcitabine and cisplatin alone group. The median duration of CR was 37.1 months in the combination cohort versus 13.2 months in the monotherapy cohort.

A total of 61.8% of patients reported grade 3 or higher treatment-related adverse events in the nivolumab group versus 51.7% of those in the monotherapy group.

“Nivolumab plus gemcitabine and cisplatin is the first frontline concurrent checkpoint inhibitor and chemotherapy combination to improve OS in this setting,” the researchers wrote. “These results support nivolumab plus cisplatin-based chemotherapy as a new standard of care for patients with mUC.”