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Nivolumab/ipilimumab falls short as frontline treatment in advanced urothelial carcinoma


The combination of nivolumab (Opdivo) and ipilimumab (Yervoy) did not improve overall survival (OS) versus standard chemotherapy in the front-line setting for patients with unresectable or metastatic urothelial carcinoma whose tumor cells express PD-L1 ≥1%, according to findings from the CheckMate-901 trial announced by Bristol Myers Squibb, the manufacturer of both immune checkpoint inhibitors.1

Based on the recommendation of an independent Data Monitoring Committee, the trial is continuing in order to evaluate the other primary and secondary endpoints. Bristol Myers Squibb noted in a news release that no new safety signals had emerged with the PD-1 inhibitors as of the time of the overall survival assessment.

Additionally, the company explained in the news release that CheckMate-901 is also evaluating nivolumab/ipilimumab in patients with unresectable or metastatic urothelial carcinoma who are cisplatin ineligible. Further, the study also included a sub-analysis exploring combination treatment with nivolumab and chemotherapy in patients who are eligible to receive cisplatin.

Dana Walker, MD, MSCE

Dana Walker, MD, MSCE

“Despite some progress in recent years, metastatic urothelial carcinoma remains a difficult disease to address, with a limited number of treatment options that can extend patients’ lives,” Dana Walker, MD, MSCE, vice president, development program lead, Genitourinary Cancers, Bristol Myers Squibb. “Opdivo plus Yervoy 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%. 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.”

Overall, the primary part of the open-label phase 3 CheckMate-901 trial randomized 707 patients with advanced urothelial carcinoma to the treatment arm of nivolumab at 1 mg/kg and ipilimumab at 3 mg/kg every 3 weeks for 4 cycles, followed by nivolumab at 480 mg every 4 weeks for up to 2 years, or the comparator arm of standard chemotherapy consisting of either gemcitabine/cisplatin or gemcitabine/carboplatin every 3 weeks for 6 cycles.

The primary end points of this primary part of the study are OS in cisplatin-ineligible patients and OS in patients with a tumor PD-L1 expression level of at least 1%. The main secondary end points are OS across all randomized patients, progression-free survival, and safety.


1. 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. Published online May 16, 2022. Accessed May 18, 2022. https://bit.ly/38v7Mzn

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