BMS's Opdivo is the first immuno-oncology treatment to receive FDA approval

Treatment proven in a Phase III trial to significantly extend overall survival for patients with recurrent or metastatic squamous cell head and neck cancer.

The approval was based on results from the Phase III, 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. The median OS was 7.5 months for Opdivo compared to 5.1 months for investigator’s choice.

“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 US Commercial, BMS. “We take tremendous pride in the unprecedented speed and rigour with which we have brought Opdivo to market to address unmet needs across more tumour types than any other immuno-oncology treatment.”

“SCCHN that progresses on or after platinum-based therapy is a debilitating and hard-to-treat disease associated with a very poor prognosis,” said Maura Gillison, lead investigator, Jeg Coughlin Chair of Cancer Research, The Ohio State University Wexner Medical Center. “This latest approval for Opdivo reinforces the potential to provide patients with improved overall survival, considered the gold standard in cancer care.”

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 US National Comprehensive Cancer Network 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 tumour types in under 2 years.