Bristol-Myers Squibb watched its stock climb 9% as investors rubbed their hands together on news that its key PD-1 checkpoint inhibitor Opdivo (nivolumab) turned in an impressive performance in patients with advanced squamous cell lung cancer.
The company assessed the drug as a single agent in a Phase II trial involving patients with the disease who progressed after at least two prior systemic treatments.
The data showed an objective response rate of 15%, while estimated one-year survival rate was 41% and median overall survival was 8.2 months, both significantly above what is normally seen in this patient population.
Furthermore, median duration of response had not been reached by 12 months, raising hopes for the drug’s performance in second-line survival trials.
The findings “are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies,” noted Suresh Ramalingam, Professor and Director of Medical Oncology, Winship Cancer Institute of Emory University. “
B-MS said it has initiated a rolling submission with FDA in April based on data from the trial, which it is expecting to complete by the end of the year.