932MO Nivolumab (NIVO) plus platinum-doublet chemotherapy (chemo) versus chemo as neoadjuvant treatment for resectable non-small cell lung cancer (NSCLC): Health-related quality of life (HRQoL) outcomes from CheckMate 816

CheckMate 816 (NCT02998528), a phase 3 study, met its primary endpoints of statistically significant and clinically meaningful improvements in event-free survival and pathological complete response with neoadjuvant NIVO + chemo vs chemo for resectable NSCLC. We present HRQoL results from the neoadjuvant treatment period. Adults with stage IB-IIIA resectable NSCLC were randomized 1:1 to neoadjuvant NIVO 360 mg + chemo Q3W or chemo Q3W for 3 cycles. HRQoL (exploratory endpoint) was evaluated using the 3-level version of the EQ-5D (EQ-5D-3L). A mixed-effects model repeated measures analysis evaluated longitudinal changes from baseline in EQ-5D visual analogue scale (VAS; range 0 to 100) and utility index (UI; range −0.594 to 1) scores during the neoadjuvant period (week 4, week 7, and post-neoadjuvant visit 1); higher scores reflect better HRQoL. EQ-5D-3L completion rates were > 80% in both treatment arms at baseline and during the neoadjuvant period. Baseline EQ-5D-3L VAS and UI scores were consistent with UK population norms. Scores during the neoadjuvant period were generally similar to baseline for both treatment arms; there were no clinically meaningful differences between NIVO + chemo vs chemo (Table). In both treatment arms, most patients reported "no problems" for individual EQ-5D-3L dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) at baseline and during treatment. Analyses from the postsurgical period will be presented.Table: 932MOEQ-5D-3L in the neoadjuvant periodLSM change from baseline95% CILSM difference95% CINIVO + chemoChemoNIVO + chemo vs chemoVAS; MID = 7Overall−0.9−2.4, 0.7−1.5−3.1, 0.10.6−1.5, 2.7Wk 4−0.4−2.1, 1.4−1.7−3.5, 0.11.3−1.0, 3.7Wk 7−1.3−3.2, 0.6−0.8−2.7, 1.2−0.6−3.2, 2.0Post-neoadjuvant visit 1−0.8−2.9, 1.2−2.0−4.1, 0.21.1−1.7, 3.9UI; MID = 0.08Overall−0.003−0.024, 0.019−0.011−0.033, 0.0110.008−0.020, 0.036Wk 40.012−0.011, 0.0360.001−0.023, 0.0250.011−0.021, 0.043Wk 7−0.006−0.033, 0.021−0.004−0.031, 0.023−0.002−0.038, 0.034Post-neoadjuvant visit 1−0.014−0.043, 0.015−0.029−0.059, 0.0010.015−0.025, 0.056LSM, least squares mean; MID, minimal important difference. Open table in a new tab LSM, least squares mean; MID, minimal important difference. In CheckMate 816, the addition of NIVO to neoadjuvant chemo for resectable NSCLC had no detrimental impact on HRQoL during the neoadjuvant period. These quality of life findings, along with previously reported efficacy and safety results, support the use of NIVO + chemo as neoadjuvant treatment for resectable NSCLC.