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news.Bristol-Myers Squibb announced that a randomized Phase 3 study evaluating Opdivo (nivolumab) versus investigator’s choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck (SCCHN) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving Opdivo compared to the control arm.
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The company looks forward to sharing these data with health authorities soon.
Bristol-Myers Squibb senior vice president, head of oncology development Michael Giordano said: "With the results of CheckMate -141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with a high unmet need and limited treatment options.
"We look forward to continuing to advance the Opdivo clinical development program in hard-to-treat cancers, such as head and neck cancer."
CheckMate -141 investigators have been informed of the decision to stop the trial early and Bristol-Myers Squibb is working to ensure that eligible patients be provided the opportunity to continue or start treatment with Opdivo as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival.
The company will complete a full evaluation of the final CheckMate -141 data, and work with investigators on the future presentation and publication of the results.
About CheckMate -141
CheckMate -141 is a Phase 3, open-label, randomized study of Opdivo versus investigator’s choice of therapy in previously treated patients with SCCHN who have tumor progression on or within 6 months of platinum therapy in the primary, recurrent, or metastatic setting.
The trial randomized 361 patients 2:1 to receive either Opdivo 3 mg/kg intravenously every two weeks or investigator’s choice (cetuximab/methotrexate/docetaxel) until documented disease progression or unacceptable toxicity.
The primary endpoint is OS. Secondary endpoints include objective response rate and progression free survival.