As stated by a press release from the Bristol-Myers Squibb Company, the Biologics License Application has been given the FDA priority review for nivolumab together with ipilimumab to treat patients, first-line, with metastatic or persistent non-small cell lung cancer with zero EGFR/ALK genomic tumor anomalies.
The BLA was issued following the data from phase III CheckMate-227 trial’s part 1, which gauged the combination relative to chemotherapy in patients whose non-small cell lung cancer was not treated previously.
According to the data, which was showcased at the Society for Immunotherapy of Cancer Annual Meeting, ipilimumab and nivolumab lead to a median overall survival of 17.2 months relative to 14.9 months in patients who had tumor PD-L1 expression greater than or equal to 1% who were given chemotherapy.
Through the nivolumab/ipilimumab a 40% overall survival was seen, relative to 33% overall survival in patients given chemotherapy.
The overall survival was also promising in the immunotherapy combination arm relative to when patients were only given nivolumab and when patients were given chemotherapy, for patients having a greater than or equal to 50% PD-L1 expression.
For the nivolumab/ipilimumab group, the median overall survival was 21.2 months, whereas, for the patients who were only given nivolumab, the overall survival was 18.1 months. For patients who were given chemotherapy, the median overall survival was 14.0 months. The median duration of response for the nivolumab/ipilimumab arm was 31.8 months, for the nivolumab-only arm it was 17.5 months, and for the chemotherapy arm, the median duration of response was 5.8 months.
For the nivolumab/ipilimumab group, the overall response rate was 35.0%, which consisted of a complete response in 5.8% of patients and partial response on 30.1% of the partakers. On the other hand, for the patients who were only given nivolumab, the overall response rate was 27.5%, which consisted of complete response in 3% of patients and partial response on 24.5% of the partakers. It was also more favorable relative to the chemotherapy arm.