Successful Phase III Checkmate 041 trial for Opdivo (nivolumab) for metastatic squamous cell carcinoma of the head and neck- BMS

Bristol-Myers Squibb Company announced the first presentation of data from CheckMate-141, a Phase III open-label, randomized trial, evaluating Opdivo (nivolumab) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab).

In the trial, which evaluated overall survival (OS) as the primary endpoint, patients treated with nivolumab experienced a 30% reduction in the risk of death, with a median OS of 7.5 months (95% CI: 5.5–9.1) compared to 5.1 months (95% CI: 4.0–6.0) for investigator’s choice (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101). The one-year survival rate for nivolumab was 36% compared to 16.6% for investigator’s choice. The safety profile of nivolumab in CheckMate-141 was consistent with prior studies, with no new safety signals identified. These data were featured during the 2016 Annual Meeting of the American Association for Cancer Research (AACR) .