Regulators on both sides of the Atlantic have agreed to review Bristol-Myers Squibb's immunotherapy Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
In the US, where the drug already carries breakthrough status for the proposed indication, the Food and Drug Administration said it will undertake a priority review of the application, with an action date of November 11.
Both submissions were 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 after platinum therapy is a devastating disease with a poor prognosis and has had very few treatment advancements in nearly a decade. Based on findings from CheckMate -141, Opdivo is the first and only PD-1 inhibitor to show an overall survival benefit in a Phase III trial in these patients," noted Jean Viallet, global clinical research lead, Oncology, at BMS.
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.