64P Patient-reported outcomes (PROs) of cemiplimab (CEMI) + platinum doublet chemotherapy (CHEMO) + ipilimumab (IPI) for first-line (1L) treatment of advanced non-small cell lung cancer (aNSCLC): EMPOWER-lung 3 part 1

In EMPOWER-Lung 3 (NCT03409614) Part 1, patients with aNSCLC and PD-L1 <50% were randomized to 3 treatment arms: CHEMO, CEMI+CHEMO or CEMI+IPI+CHEMO. Clinical outcomes for CEMI+IPI+CHEMO vs CHEMO (including OS [HR: 0.615 (95% CI, 0.441–0.857)]) were previously reported; safety profile was generally consistent with the known safety for CEMI, CHEMO and IPI. PROs were evaluated and reported here. PROs were assessed at day 1 (baseline), the start of each treatment cycle (every 3 weeks) for the first 6 doses, and then the start of every 3 cycles, using the EORTC QLQ-C30 and QLQ-LC13 questionnaires. Time to definitive clinically meaningful deterioration (TTD) analysis was conducted and between-arm (CEMI+IPI+CHEMO [n=109] vs CHEMO [n=106]) TTD comparisons were made per stratified log-rank test and proportional hazards model for global health status (GHS)/quality of life (QoL). A mixed-effect model for repeated measures compared overall differences in score changes from baseline between arms. No adjustments for multiplicity were conducted. Significant delay in TTD in GHS/QoL favouring CEMI+IPI+CHEMO vs CHEMO [HR: 0.45 (95% CI, 0.23–0.86); P=0.014] was observed; significant TTD delays favouring CEMI+IPI+CHEMO were also observed in functions: physical, role, emotional and social; and symptoms: fatigue, nausea/vomiting, pain, dyspnoea (QLQ-C30), insomnia, appetite loss, diarrhoea, sore mouth, peripheral neuropathy, alopecia, pain in arm or shoulder, pain in chest, and pain in other parts. Significant overall differences in score changes favouring CEMI+IPI+CHEMO vs CHEMO was observed in fatigue, nausea/vomiting, appetite loss and alopecia. When comparing between arms, no analyses yielded statistically significant PRO results favouring CHEMO for any scale. In patients with PD-L1 <50% aNSCLC, CEMI+IPI+CHEMO vs CHEMO resulted in significant overall improvement and delayed TTD in multiple cancer-related and lung cancer-specific PROs. Positive PROs further support the favourable benefit–risk profile of CEMI+IPI+CHEMO in 1L aNSCLC with PD-L1 <50%.