CheckMate 8HW

ResultAcross all treatment lines, median OS was not reached with nivolumab plus ipilimumab (n = 296) or with nivolumab (n = 286): HR 0.61 (95% CI 0.46-0.82; P = 0.0009). In first line, median OS was not reached with nivolumab plus ipilimumab (n = 171) vs 50.1 months (95% CI 31.7-NE) with chemotherapy (n = 84): HR 0.37 (95% CI 0.24-0.57; P < 0.0001). In first line vs nivolumab (n = 170), median OS was not reached in either arm: HR 0.66 (95% CI 0.44-0.99; P = 0.0432), which was not statistically significant against a significance boundary of P = 0.0058. Median PFS across all lines was not reached (71.7-NE) vs 39.3 months (23.0-58.7) with nivolumab, HR 0.60 (95% CI 0.47-0.77). In first line it was not reached (64.3-NE) vs 5.9 months (4.4-7.8) with chemotherapy, HR 0.21 (95% CI 0.14-0.32), and not reached (64.3-NE) vs 60.8 months (32.8-NE) with nivolumab, HR 0.68 (95% CI 0.48-0.96). ORR (descriptive) was 72% vs 58% across all lines, 74% vs 27% vs chemotherapy in first line, and 74% vs 61% vs nivolumab in first line. Median duration of response was 8.2 months (5.9-17.6) with chemotherapy and was not reached in the immunotherapy arms. There were no new safety signals and no additional treatment-related deaths. Median follow-up was 68.1 months (range 37.6-81.4).