Bristol-Myers Squibb's Opdivo has become the first immuno-oncology therapy to win US Food and Drug Administration approval for head and neck cancer.
The regulator has cleared the drug's 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.
The submission was based on data from the Phase III CheckMate -141 trial, that evaluated the overall survival (OS) of Opdivo (nivolumab) in patients with SCCHN after platinum therapy compared to investigator's choice of therapy (methotrexate, docetaxel, or cetuximab).
A first look at the data from study, stopped early in January 2016 after meeting its primary endpoint of overall survival, showed that patients treated with Opdivo experienced a 30 percent reduction in the risk of death compared to the investigator's choice of therapy, with a median overall survival of 7.5 months versus to 5.1 months.
Safety signals were also looking good, with treatment-related adverse events (TRAEs) of any grade occurring in 58.9 percent of patients on Opdivo versus 77.5 percent of patients on investigator's choice. Grade 3-4 TRAEs were reported in 13.1 percent of patients on Opdivo compared to 35.1 percent taking the investigator's choice, while two drug-related deaths were reported as related to Opdivo (pneumonitis and hypercalcaemia), and one Grade 5 event of lung infection in the comparator arm.
"Squamous cell carcinoma of the head and neck 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."
Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five-year survival rate is reported as less than 4 percent for metastatic Stage IV disease.
European regulators are also currently reviewing Opdivo in this setting.