Bristol-Myers Squibb has announced long-term efficacy and safety results from its Phase III CheckMate -017 and CheckMate -057 studies, involving patients with previously treated advanced non-small cell lung cancer (NSCLC).
The pooled five-year survival data showed that patients treated with Opdivo (nivolumab) continued to experience long-term overall survival benefits compared to docetaxel. Specifically, overall survival rates at five years were 13.4% for Opdivo and just 2.6% for docetaxel, a result that was observed across all subgroups.
The company also revealed that the safety profile for patients treated with Opdivo was consistent with previously reported findings in second-line NSCLC, and that no new safety signals were seen with extended follow-up.
Among patients with an objective response to Opdivo, 32.2% continued to see a response at five years, whereas 0% of patients with an objective response to docetaxel continued to see a response at five years.
Sabine Maier, MD, development lead, Thoracic Cancers, Bristol-Myers Squibb, said: “Since the US Food and Drug Administration approval in second-line non-small cell lung cancer in 2015, Opdivo has become an important treatment option for this population of patients, who historically faced five-year survival rates of less than 5% when treated with standard chemotherapy.
“The long-term survival outcomes from these two studies in a large patient population add to the body of evidence supporting the durability of Opdivo-based regimens, which has now been demonstrated across multiple tumour types and lines of therapy.”