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At five years, patients who were treated with nivolumab experienced a five-fold increase in long-term 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.
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.
“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.”