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Nivolumab Plus Gemcitabine-Cisplatin Improved Survival Outcomes Among Patients With Advanced Urothelial Carcinoma
Results from the CheckMate901 Trial
Results from the CheckMate901 Trial
In a phase 3, multinational, open-label trial, nivolumab plus gemcitabine-cisplatin resulted in statistically significant prolonged overall survival (OS) and progression-free survival (PFS) among patients with previously untreated advanced urothelial carcinoma, compared with gemcitabine-cisplatin alone.
The CheckMate901 trial enrolled 608 patients with previously untreated unresectable or metastatic urothelial carcinoma. Patients were randomized on a 1-to-1 basis to receive either 360 mg nivolumab plus gemcitabine-cisplatin every 3 weeks for up to 6 cycles, followed by 480 mg nivolumab every 4 weeks for up to 2 years (n = 304, nivolumab combination arm) or gemcitabine-cisplatin alone (n = 304). The primary outcomes were overall survival and progression-free survival. Exploratory outcomes included objective response rate and safety.
At a median follow-up duration of 33.6 months, the median OS in the nivolumab combination arm was 21.7 months vs 18.9 months in the gemcitabine-cisplatin arm (hazard ratio [HR] for death, 0.78; 95% confidence interval [CI], 0.63 to 0.96; P = .02). The median PFS in the nivolumab combination arm 7.9 months vs 7.6 months in the gemcitabine-cisplatin arm (HR for death, 0.72; 95% CI, 0.59 to 0.88; P = .001. The 12-month PFS rate was 34.2% in the nivolumab combination arm vs 21.8% in the gemcitabine-cisplatin arm. The overall response rate was 57.6% and 43.1%, respectively. The incidence of grade ≥3 adverse events was 61.8% in the nivolumab combination arm and 51.7% in the gemcitabine-cisplatin arm.
According to Michiel S van der Heijden, MD, PhD, Netherlands Cancer Institute, Amsterdam, Netherlands, and coauthors, “Combination therapy with nivolumab plus gemcitabine-cisplatin resulted in significantly better outcomes in patients with previously untreated advanced urothelial carcinoma than gemcitabine-cisplatin alone.”
Source:
Van der Heijden MS, Sonpavde G, Powles T, et al. Nivolumab plus gemcitabine-cisplatin in advanced urothelial carcinoma. N Eng J Med. Published online November 9, 2023. doi:10.1056/NEJMoa2309863
