Bristol Myers Squibb’s Check Mate -901 Fails to Meet Primary Endpoint of Overall Survival


Independent committee recommends the phase 3 clinical trial continues to assess other primary and secondary endpoints for the treatment of unresectable or metastatic urothelial carcinoma.

Bristol Myers Squibb announced that the phase 3 CheckMate -901 trial did not meet the primary endpoint of overall survival (OS) in individuals whose tumor cells express PD-L1 ≥1%, comparing nivolumab (Opdivo) plus ipilimumab (Yervoy) to the standard-of-care chemotherapy as a first-line treatment for individuals with untreated unresectable or metastatic urothelial carcinoma.

The company is blind to the data, and an independent data monitoring committee recommended that the trial continue to assess other primary and secondary endpoints. At the time of the analysis, there were no new safety signals observed.

“Nivolumab plus ipilimumab has demonstrated durable, long-term survival improvements in several challenging-to-treat advanced cancers, and we are disappointed that the final analysis of CheckMate -901 did not show this same benefit in urothelial carcinoma patients whose tumor cells express PD-L1 ≥1%,” Dana Walker, MD, MSCE, vice president and development program lead of genitourinary cancers at Bristol Myers Squibb, said in a statement. “We remain committed to advancing research in urothelial carcinoma, we look forward to seeing data from other parts of the CheckMate -901 trial, and we thank all of the patients, investigators and site personnel involved.”

The trial also assessed nivolumab plus ipilimumab in individuals with unresectable or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy.

Additionally, a sub-study of CheckMate -901 with pivotal intent is evaluating nivolumab in combination with chemotherapy versus chemotherapy alone in individuals who are eligible for cisplatin-based chemotherapy.

The primary and sub-study are both ongoing, and the company will report results for the additional components when they are available.

Nivolumab plus ipilimumab-based combinations have shown significant improvements in OS in 6 phase 3 clinical trials in 5 tumors, which included advanced renal cell carcinoma, esophageal squamous cell carcinoma, malignant pleural mesothelioma, metastatic melanoma, and non–small cell lung cancer, .

Furthermore, nivolumab has shown clinical benefit in second-line metastatic urothelial carcinoma and adjuvant muscle-invasive urothelial carcinoma.

In the primary study, a total of 707 individuals were randomized to receive either combination therapy for 3 weeks for 4 cycles, followed by nivolumab every 4 weeks for a maximum of 2 years or gemcitabine-cisplatin or gemcitabine-carboplatin every 3 weeks for 6 cycles.

The key secondary endpoints include OS in all randomized individuals, progression-free survival (PFS), and safety outcomes.

The OS outcomes for individuals whose tumor cells express PD-L1 ≥1% of the overall study are based on the final efficacy analysis for this endpoint of the CheckMate -901 primary study.

The other parts of the study are ongoing.

Nivolumab is a programmed death-1 immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.

The drug has been approved in more than 65 countries, including China, the European Union, Japan, and the United States.


Bristol Myers Squibb provides update on CheckMate -901 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line treatment for patients with unresectable or metastatic urothelial carcinoma. Bristol Myers Squibb. News release. May 16, 2022. Accessed May 16, 2022.

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