Dr Sonpavde on Nivolumab Plus Ipilimumab in Untreated Unresectable/Metastatic Urothelial Carcinoma

“[Although] the [OS data] did not meet the statistical bar for superiority, there were some very interesting signals for efficacy [with nivolumab plus ipilimumab].”

Guru P. Sonpavde, MD, medical director of Genitourinary (GU) Oncology, assistant director of the Clinical Research Unit, and Christopher K. Glanz Chair for Bladder Cancer Research at AdventHealth Cancer Institute, discussed efficacy data from the phase 3 CheckMate 901 trial (NCT03036098) of nivolumab (Opdivo) plus ipilimumab (Yervoy) vs chemotherapy in patients with treatment-naive unresectable or metastatic urothelial carcinoma.

Prior data from CheckMate 901 supported the March 2024 FDA approval of nivolumab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. During the 2025 ASCO Annual Meeting, investigators presented data from the final analysis of CheckMate 901 which demonstrated that the nivolumab plus ipilimumab arm failed to meet the primary end point of overall survival (OS) in cisplatin-ineligible patients, Sonpavde said.

The median OS among patients who received nivolumab plus ipilimumab (n = 221) was 19.1 months (95% CI, 13.5-22.6) compared with 13.2 months (95% CI, 11.6-15.2) in the gemcitabine plus carboplatin arm (n = 224; HR, 0.79; 98.27% CI, 0.61-1.01; P = .0245), Sonpavde explained. The 60-month OS rates were 23.0% and 14.4%, respectively.

Although the primary end point was not met in this population, the combination of nivolumab plus ipilimumab did display other interesting efficacy signals, Sonpavde said. The objective response rate in the nivolumab plus ipilimumab arm was 35.3% (95% CI, 29.0%-42.0%) vs 38.8% (95% CI, 32.4%-45.6%) in the chemotherapy arm. The combination produced a median duration of response of 25.0 months (95% CI, 14.8-61.8) vs 7.4 months (95% CI, 5.8-8.5) in the chemotherapy arm, Sonpavde noted.

Nivolumab plus ipilimumab also displayed a complete response (CR) rate of 14.9%, with a duration of complete response that was not reached (95% CI, 33.4-not evaluable), Sonpavde highlighted. These respective values in the control arm were 8.9% and 20.3 months (95% CI, 8.5-28.9).

Nivolumab plus ipilimumab did not produce a benefit vs gemcitabine plus carboplatin in terms of progression-free survival (PFS), Sonpavde said. The median PFS was 5.3 months (95% CI, 3.8-6.0) vs 5.9 months (95% CI, 5.6-7.6), respectively (HR, 0.90; 95% CI, 0.72-1.12).