FDA Approves First-line Nivolumab Combo for Urothelial Carcinoma

Findings from the CHECKMATE-901 trial (NCT03036098) support the FDA approval of nivolumab plus cisplatin and gemcitabine for patients with unresectable or metastatic urothelial carcinoma.

The FDA has approved nivolumab (Opdivo) plus cisplatin and gemcitabine as first-line treatment for patients with unresectable or metastatic urothelial carcinoma, according to a press release from the FDA.¹

The approval is based on results from the phase 3 CHECKMATE-901 trial (NCT03036098), which assessed 608 patients with previously untreated unresectable or metastatic urothelial carcinoma.² Patients were randomly assigned 1:1 to the combination arm for up to 6 cycles followed by nivolumab alone for up to 2 years or the chemotherapy arm for up to 6 cycles.

The median overall survival was 21.7 months (95% CI, 18.6-26.4) in the combination arm vs 18.9 months (95% CI, 14.7-22.4) in the chemotherapy alone arm (HR, 0.78; 95% CI, 0.63-0.96; P = .0171). The median progression-free survival was 7.9 months (95% CI, 7.6-9.5) vs 7.6 months (95% CI, 6.0-7.8) between both arms, respectively. (HR, 0.72; 95% CI, 0.59-0.88; P = .0012).

The recommended dose of nivolumab in this indication is 360 mg every 3 weeks plus cisplatin and gemcitabine every 3 weeks for 6 weeks followed by nivolumab at 240 mg every 2 weeks or 480 mg every 4 weeks as monotherapy until progressive disease, unacceptable toxicity, or a maximum treatment duration of 2 years from the first dose.

The most common adverse effects that occurred in 15% or more of patients in the combination arm included nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, and vomiting.

References

1. FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma. News release. FDA. March 6, 2024. Accessed March 7, 2024. https://shorturl.at/jtwL9
2. van der Heijden MS, Sonpavde G, Powles T, et al. Nivolumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin alone for previously untreated unresectable or metastatic urothelial carcinoma: Results from the phase III CheckMate 901 trial. Presented at: ESMO Congress 2023; October 20-24, 2023; Madrid, Spain. Abstract LBA7.