Bristol-Myers Squibb (BMS) has stopped its open-label, randomised Phase III trial (CheckMate -017) evaluating Opdivo versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer (NSCLC).
CheckMate -017 was stopped early due to an evaluation conducted by the independent Data Monitoring Committee (DMC), which concluded that the trial met its endpoint, showing superior overall survival in patients receiving Opdivo compared to the control arm.
The company said that CheckMate -017 investigators are being informed of the decision to stop the comparative portion of the trial.
Currently, the company is working to inform eligible patients about the opportunity to continue or start treatment with Opdivo in an open-label extension as part of its commitment to providing patient access to Opdivo, and characterising long-term survival.
A total of 272 patients were enrolled in the trial and were given either nivolumab 3mg/kg intravenously every two weeks or docetaxel 75mg/m2 intravenously every three weeks.
The trial’s primary endpoint is overall survival, while secondary endpoints include objective response rate and progression free survival.
The company now intends to complete full evaluation of the final trial data and work with investigators on the future presentation and publication of the results.
According to the World Health Organization (WHO), lung cancer results in over 1.5 million deaths each year across the world and NSCLC is one of the most common types of the disease and accounts for about 85% of cases.
The company has a broad, global development programme to study Opdivo in multiple tumour types consisting of over 50 trials in which more than 7,000 patients have been enrolled across the world.
In the US, Opdivo is used to treat patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.