CLO22-074: Patient-Reported Outcomes (PROs) in Patients (pts) With Advanced Non-Small Cell Lung Cancer (aNSCLC) With Programmed Cell Death-Ligand 1 (PD-L1) ≥50% Receiving Cemiplimab (CEMI) Monotherapy Versus Platinum-Doublet Chemotherapy (CHEMO): A Focus on the EMPOWER-Lung 1 Brain Metastases Subpopulation

Background: Previously reported subgroup analysis of EMPOWER-Lung 1 (NCT03088540), a randomized 1:1 open-label phase 3 study, showed an improvement in overall survival (OS) (median OS, 18.7 vs 11.7 months; hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.04, 0.76; P=0.0091) and progression-free survival (PFS) (median PFS, 10.4 vs 5.3 months; hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.22, 0.92; P=0. 0.0231) with CEMI (n=34) versus CHEMO (n=34), in aNSCLC pts with PD-L1 ≥50% and clinically stable treated brain metastases at baseline. Post-hoc exploratory analyses were conducted to evaluate PROs in this subgroup of pts. Methods: PROs were assessed at baseline and day 1 of each treatment cycle for the first 6 cycles, and then on day 1 of every third cycle using European Organisation for Research and Treatment of Cancer Quality-of-Life Core 30 (QLQ-C30) and Lung Cancer Module (QLQ-LC13) questionnaires. Higher scores indicate better functioning, global health status (GHS)/quality of life (QoL), or worse symptom severity. Mixed model for repeated measures analyses were performed to compare overall change from baseline scores between the 2 treatment arms, while controlling for baseline characteristics. Results: The baseline PRO scores of the CEMI arm were broadly similar with the CHEMO arm. A statistically significant overall change from baseline in GHS/QoL favoring CEMI versus CHEMO (9.35; 95% CI, 2.24, 16.45; p=0.0110) was observed. CEMI also resulted in a statistically significant favorable difference in overall change from baseline in role functioning (8.59; 95% CI, 0.16, 17.01; p=0.0459), emotional functioning (7.27; 95% CI, 1.86, 12.69; p=0.0095), and symptoms of fatigue (-8.19; 95% CI, -15.40, -0.98; p=0.0268) and appetite loss (-7.43; 95% CI, -14.48, -0.38; p=0.0393). When comparing between arms, no analyses yielded statistically significant PRO results favoring CHEMO for any QLQ-C30 or QLQ-LC13 scale. Conclusions: In pts with aNSCLC with PD-L1 ≥50% and treated clinically stable brain metastases at baseline, CEMI resulted in significantly favorable overall change from baseline in GHS/QoL, role and emotional functioning, and fatigue and appetite loss symptoms compared with CHEMO. PRO results further support the favorable benefit-risk profile of first-line CEMI versus CHEMO in aNSCLC with PD-L1 ≥50% and clinically stable brain metastases.