Bristol-Myers Squibb’s immunotherapy Opdivo has shown a significant survival benefit in a late-stage trial assessing its potential in patients with metastatic squamous cell carcinoma of the head and neck.
A first look at the data from the Phase III CheckMate-141 trial, which compared the drug against the investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab), patients treated with Opdivo (nivolumab) experienced a 30 percent reduction in the risk of death, with a median overall survival of 7.5 months versus to 5.1 months).
Also, the drug’s safety profile was consistent with prior studies with no new safety signals identified. Treatment-related adverse events (TRAEs) of any grade occurred 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.
“We are encouraged by the overall survival results seen with this investigational use of Opdivo versus three standard of care options for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, who often face poor survival rates,” said Jean Viallet, global clinical research lead of Oncology at BMS.
The findings are particularly pertinent given the particularly bleak outlook for patients whose disease has progressed after platinum therapy and lack of system therapies to improve survival, and thus significant unmet medical need for new options.
Opdivo is already available in the US to treat certain forms of melanoma, non-small cell lung cancer and renal cell carcinoma. Just days ago the US Food and Drug Administration issued the drug with a breakthrough badge in the classical Hodgkin lymphoma indication.