Background: EMPOWER-Lung 1, a randomized 1:1, open-label, global, phase 3 study (NCT03088540), showed a statistically significant and clinically meaningful improvement in overall survival (hazard ratio, 0.57; 95% confidence interval, 0.42, 0.77; P =0.0002) and progression-free survival (hazard ratio, 0.54; 95% confidence interval, 0.43, 0.68; P <0.0001), favorable patient-reported outcomes with cemiplimab (CEMI) monotherapy versus physician’s choice of platinum-doublet chemotherapy (CHEMO) in pts with aNSCLC with PD-L1 ≥50%. We evaluated hospitalization and SCM utilization while accounting for CEMI or CHEMO treatment-emergent period in EMPOWER-Lung 1. Methods: In the EMPOWER-Lung 1 safety population (while pts were on CEMI or CHEMO), the following were compared between CEMI- and CHEMO-treated pts: serious adverse event (SAE)-associated hospitalization rates (per 100 patient-years), number of pts with ≥1 platelet/red blood cell (PRBC) transfusions, and 11 types of SCM (opiate, antiemetic/antinauseant, antidiarrheal, appetite stimulant, bone disease treatment, anti-anemic, immunostimulant, antibacterial, antimycotic, antiviral, and corticosteroid) utilization ratios (total duration of each SCM type/treatment-emergent period, in 1000 days). Results: EMPOWER-Lung 1 safety population consisted of 355 CEMI- and 342 CHEMO-treated pts. Lower rates of SAE-associated hospitalization were observed with CEMI- versus CHEMO-treated pts (33.2 vs 56.7 per 100 patient-years). One (0.3%) CEMI-treated pt versus 3 (0.9%) CHEMO-treated pts had ≥1 platelet transfusions; 4 (1.1%) CEMI-treated pts versus 24 (7.0%) CHEMO-treated pts had ≥1 PRBC transfusions. Nine of 11 SCM utilization ratios for CEMI-treated pts were lower than those for CHEMO-treated pts (Table). Conclusions: In EMPOWER-Lung 1, pts with aNSCLC treated with CEMI versus CHEMO had lower SAE-associated hospitalization rates. Except for antidiarrheal and antiviral for systemic use, all other SCM utilization ratios were lower with CEMI. These results support the favorable clinical and patient-reported outcomes observed with CEMI- versus CHEMO-treated pts in EMPOWER-Lung 1.
CLO22-050 Table. Supportive Care Medication utilization in EMPOWER-Lung 1
CEMI, cemiplimab; CHEMO, chemotherapy; PRBC, platelet/red blood cell; SCM, supportive care medication.