121P Health-related quality of life (HRQoL) outcomes from CheckMate 77T: Neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) followed by adjuvant NIVO in resectable NSCLC

CheckMate 77T (NCT04025879) demonstrated statistically significant and clinically meaningful improvement in event-free survival for perioperative NIVO added to neoadjuvant (neoadj) chemo (NIVO+chemo/NIVO) vs perioperative placebo added to neoadj chemo (chemo/PBO) in patients (pts) with resectable NSCLC. Here we report HRQoL results. Adults with untreated, resectable stage IIA-IIIB NSCLC were randomized 1:1 to NIVO 360 mg Q3W + chemo (4 cycles) followed by surgery and adjuvant (adj) NIVO 480 mg Q4W (1 y), or PBO Q3W + chemo (4 cycles) followed by surgery and adj PBO Q4W (1 y). Pt-reported outcome (PRO) measures included NSCLC-SAQ, FACT-L, EQ-5D-3L, and PROMIS Physical Function Short-Form 8c. The assessment schedule was the same in both treatment (tx) arms. Changes from baseline (BL) were analyzed using a mixed model for repeated measures. Time to definitive deterioration (TTDD) was defined as time from randomization to worsening from BL with no subsequent improvement. Completion rates for all PRO measures were mostly > 90%, except at pre- and postsurgical visits. BL scores indicated good HRQoL for pts in both tx arms. Pts generally maintained their HRQoL during tx, except at the postsurgical visit. Least squares mean change (95% CI) from BL over the on-tx period for NSCLC-SAQ was 0.26 (−0.06 to 0.58) in the NIVO+chemo/NIVO arm and 0.33 (0.02 to 0.65) in the chemo/PBO arm and ranged from −0.51 to 1.71 and −0.76 to 1.43, respectively. Pts treated with NIVO+chemo/NIVO had delayed median TTDD vs those treated with chemo/PBO (NSCLC-SAQ HR 0.66 95% CI 0.45–0.98; results in table). Table: 121PTTDD in all randomized ptsScaleMedian TTDDa, mo (95% CI)HR (95% CI)NIVO+chemo/NIVO n = 229Chemo/PBO n = 232NSCLC-SAQb40.0 (33.6–NR)31.1 (25.0–NR)0.66 (0.45–0.98)FACT-L LCSc32.7 (27.2–NR)27.5 (20.2–NR)0.69 (0.49–0.97)EQ-5D-3L UId31.3 (25.8–NR)26.6 (20.9–NR)0.82 (0.60–1.12)EQ-5D-3L VASeNR (36.6–NR)NR (22.8–NR)0.67 (0.47–0.96)aTTDD was assessed during tx and follow-up. RD of ≥ b+3, c−3, d−0.08, and e−7 point changes from BL. FACT-L, Functional Assessment of Cancer Therapy - Lung; LCS, Lung Cancer Subscale; NR, not reached; NSCLC-SAQ, NSCLC Symptom Assessment Questionnaire; RD, responder definition; UI, utility index; VAS, visual analogue scale. Open table in a new tab aTTDD was assessed during tx and follow-up. RD of ≥ b+3, c−3, d−0.08, and e−7 point changes from BL. FACT-L, Functional Assessment of Cancer Therapy - Lung; LCS, Lung Cancer Subscale; NR, not reached; NSCLC-SAQ, NSCLC Symptom Assessment Questionnaire; RD, responder definition; UI, utility index; VAS, visual analogue scale. In CheckMate 77T, perioperative NIVO did not adversely impact HRQoL during the tx period and reduced the risk of definitive deterioration vs chemo/PBO. These findings, along with previously reported efficacy and safety results, support perioperative NIVO as a potential tx option for pts with resectable NSCLC.