US regulators have awarded Bristol-Myers Squibb’s immunotherapy Opdivo a breakthrough designation for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
The move, which should help expedite the drug’s development and review, comes after preliminary clinical evidence indicated it could offer a substantial survival benefit to patients with the condition who have already received platinum-based therapy.
A first look at the data from the Phase III CheckMate-141 trial, stopped early in January 2016 after meeting its primary endpoint of overall survival, showed that patients treated with Opdivo (nivolumab) experienced a 30 percent reduction in the risk of death compared to the investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab), 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.
The findings are particularly pertinent given the particularly bleak outlook for patients whose disease has progressed after platinum therapy and lack of systemic therapies to improve survival, and thus significant unmet medical need for new options.
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% for metastatic Stage IV disease.
Opdivo is already available in the US to treat certain forms of melanoma, non-small cell lung cancer and renal cell carcinoma. This marks its fifth breakthrough designation from the FDA, and follows that for classical Hodgkin lymphoma issued just days ago.