FDA approves first immuno-oncology treatment based on overall survival in head and neck cancer

The US Food and Drug Administration has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

Opdivo, from US pharma major Bristol-Myers Squibb (NYSE: BMY), is the first and only immuno-oncology treatment proven in a Phase III trial to significantly extend overall survival (OS) for these patients. In oncology clinical trials, OS is considered the gold standard primary endpoint to evaluate the outcome of any therapy, the company notes.

The approval was based on results from the Phase III, CheckMate -141 trial in which Opdivo demonstrated statistically significant and clinically meaningful superior OS versus the comparator arm (investigator’s choice of methotrexate, docetaxel or cetuximab), with a 30% reduction in the risk of death (HR=0.70 [95% CI: 0.53-0.92; p=0.0101]). The median OS was 7.5 months (95% CI: 5.5-9.1) for Opdivo compared to 5.1 months (95% CI: 4.0-6.0) for investigator’s choice. Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; and embryo-fetal toxicity. Please see the Important Safety Information section below.