Combination fails to extend OS in urothelial carcinoma
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Nivolumab plus ipilimumab failed to extend OS compared with standard first-line chemotherapy for patients with unresctable or metastatic urothelial carcinoma whose tumor cells expressed PD-L1 at 1% or greater.
An independent data monitoring committee recommended the randomized phase 3 CheckMate -901 trial continue to allow for assessment of other primary and secondary endpoints.
Nivolumab (Opdivo, Bristol Myers Squibb) is an anti-PD-1 antibody. Ipilimumab (Yervoy, Bristol Myers Squibb) is an anti-CTLA-4 antibody.
The combination is approved in the United States for treatment of certain patients with melanoma, lung cancer, mesothelioma, renal cell carcinoma, colorectal cancer and hepatocellular carcinoma.
The open-label CheckMate -901 trial included 707 patients with untreated unresectable or metastatic urothelial cancer.
Patients assigned the experimental regimen received 1 mg/kg nivolumab plus 3 mg/kg ipilimumab every 3 weeks for four cycles, followed by 480 mg nivolumab every 4 weeks for a maximum of 2 years. Patients assigned chemotherapy received gemcitabine-cisplatin or gemcitabine-carboplatin every 3 weeks for six cycles.
OS among patients ineligible for cisplatin-based chemotherapy or among those with tumor cell PD-L1 expression of 1% or greater served as primary endpoints. Key secondary endpoints included OS among all randomly assigned patients, as well as PFS and safety outcomes.
The lack of OS benefit among patients whose tumor cells expressed PD-L1 at 1% or greater emerged from the final efficacy analysis for this endpoint, according to a Bristol Myers Squibb-issued press release.
Researchers observed no new safety signals with the nivolumab-ipilimumab combination.
“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 and development program lead for genitourinary cancers at Bristol Myers Squibb, said in the release. “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 [at 1% or greater].”
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