Bristol-Myers Squibb has stopped a Phase III study assessing its immunotherapy nivolumab in melanoma after independent regulators found that it showed a superior survival benefit over the chemotherapy dacarbazine.
The drugmaker said that all patients with previously-untreated BRAF wild-type advanced melanoma taking part in the trial will now be given the opportunity to receive its drug in an open-label extension.
“The outcome of CheckMate-066 is an important milestone in the field of immuno-oncology as it represents the first well-controlled, randomised Phase III trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit,” noted Michael Giordano, Head of Oncology Development.
A full evaluation of data will now be undertaken, and the firm said it will work with investigators on the future presentation and publication of the results.
There is already much hype over the potential of nivolumab, which is being studied in multiple tumour types in 35 different trials. According to recent forecasts, the drug is expected to dominate the non-small cell lung cancer market by 2022.