Cemiplimab monotherapy as first‐line treatment of patients with brain metastases from advanced non–small cell lung cancer with programmed cell death‐ligand 1 ≥50%

Abstract Background In the phase 3 EMPOWER‐Lung 1 study, first‐line cemiplimab monotherapy provided significant survival benefit versus chemotherapy in patients with advanced non–small cell lung cancer (NSCLC) with programmed cell death‐ligand 1 (PD‐L1) ≥50%. This exploratory subgroup analysis investigated the clinical outcomes of cemiplimab treatment in patients with advanced NSCLC with brain metastases. Methods Patients with advanced NSCLC were randomized (1:1) to cemiplimab 350 mg every 3 weeks or four cycles of platinum doublet chemotherapy (NCT03088540). Patients with symptomatic radiotherapy‐treated brain metastases were eligible to enroll. Of the 565 patients with confirmed PD‐L1 expression ≥50%, 69 (12%) had brain metastases at baseline. Results Patients with brain metastases who received cemiplimab had a median overall survival (OS) of 52.4 months compared with 20.7 months for those who received chemotherapy (hazard ratio [HR], 0.40; p = .0031) and a median progression‐free survival (PFS) of 12.5 versus 5.3 months (HR, 0.33; p = .0002), respectively. Patients without brain metastases had a median OS of 24.3 months with cemiplimab versus 12.5 months with chemotherapy (HR, 0.63; p < .0001); their median PFS was 6.5 months versus 5.2 months (HR, 0.55; p < .0001), respectively. Cemiplimab was associated with a significant improvement in global health status/quality of life in all patients, including those with brain metastases. The cemiplimab safety profile was generally similar in all patients. Conclusions In patients with advanced NSCLC with PD‐L1 ≥50%, first‐line cemiplimab monotherapy improved survival and patient‐reported outcomes over chemotherapy for those who received prior radiotherapy for symptomatic brain metastases.