Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) 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 is the first and only Immuno-Oncology treatment proven in a Phase 3 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 approval was based on results from the Phase 3, CheckMate -141 trial in which Opdivo demonstrated statistically significant and clinically meaningful superior OS vs 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.
“With this approval in head and neck cancer, we continue to lead the field in bringing our Immuno-Oncology science and the potential for increasing survival to more people with cancer,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb. “We take tremendous pride in the unprecedented speed and rigor with which we have brought Opdivo to market to address unmet needs across more tumor types than any other Immuno-Oncology treatment.”
Squamous cell carcinoma of the head and neck (SCCHN) accounts for more than 90% of all head and neck cancers, and more than 50% of SCCHN patients present with Stage III or higher disease (locally advanced or metastatic), which has higher potential for progression and recurrence.The relative five-year survival rate for metastatic head and neck cancers is <38%, and can be as low as 4% for recurrent or metastatic Stage IV disease.
Based on a pre-planned interim analysis, CheckMate -141 was stopped early in January 2016 because an assessment conducted by the independent Data Monitoring Committee concluded the study met its primary endpoint of OS. In April 2016, the FDA granted Breakthrough Therapy Designation to Opdivo for recurrent or metastatic SCCHN after platinum-based therapy, underscoring the need for new treatment approaches for this disease. In October, the U.S. National Comprehensive Cancer Network (NCCN) updated its clinical practice guidelines to recommend treatment with Opdivo as the only category 1 single-agent therapy for patients with recurrent or metastatic head and neck cancer with disease progression on or after platinum-containing chemotherapy. Opdivo has now been approved in five tumor types in under two years.
