Results from the pooled analysis of the CheckMate -017 and -057 studies of five-year overall survival in patients with previously-treated advanced non-small cell lung cancer have been announced.
Among patients with an objective response to nivolumab, 32.2% continued to see a response at five years compared to 0% on docetaxel. The median duration of response was 19.9 months for nivolumab-treated patients versus 5.6 months for docetaxel.
At five years, patients who were treated with nivolumab experienced a five-fold increase in long-term overall survival (OS) benefit versus docetaxel, with OS rates of 13.4% versus 2.6%, respectively. The primary endpoint of OS benefit (CheckMate 017 mOS 9.2 vs 6.0 months, HR 0.59, 95% CI 0.4, 0.79; p<0.001; CheckMate 057 mOS 12.2 vs 9.4 months, HR 0.73, 96% CI 0.59, 0.89; p=0.002) for nivolumab-treated patients was observed across all subgroups.
The safety profile for patients treated with nivolumab was consistent with previously reported findings in second-line NSCLC and no new safety signals were seen with extended follow-up. Of patients still on study, only two of 70 (1.4%) experienced a new treatment-related select adverse event (AE) between years three and four and there were no new treatment-related select AEs reported between years four and five among the 55 patients still on the study.
“We are delighted with the results of the pooled analysis, which demonstrate the long-term survival outcomes, in a large patient population, and provides evidence of the five year durability of nivolumab,” said Faisal Mehmud, UK Country Medical Director, Bristol-Myers Squibb. “IO has become an important treatment option for patients living with NSCLC and these data help to reinforce the place of nivolumab in the treatment pathway.”