A recent phase 3 clinical trial studied the use of cemiplimab as a first-line treatment of advanced non-small-cell lung cancer with a PDL1 of at least 50%.
Results of the EMPOWER-Lung 1 trial were published in The Lancet, including 710 patients from 138 clinics in 24 countries who were randomly assigned to receive cemiplimab every three weeks or platinum-doublet chemotherapy. The trial’s primary endpoints included overall survival and progression-free survival, which were evaluated in an intent to treat arm and among those with PD-L1 of at least 50%.
The median overall survival was not reached (95% CI, 17.9-not evaluable) among the PD-L1 ≥50% population, compared to 14.2 months (11.2-17.5) in the chemotherapy arm (n=280; HR 0.57 [0.42-0.77]; p=0.0002). The median progression-free survival was 8.2 months (6.1-8.8) in the cemiplimab arm compared to 5.7 months (4.5-6.2) with chemotherapy (HR 0.54 p0.43-0.68]; p<0.0001). There were also “significant improvements” in overall survival and progression-free survival in the intention-to-treat population.
“These clinical results published in The Lancet support regulatory submissions for [cemiplimab] as a potential new treatment option for patients with advanced NSCLC with PD-L1 expression of ≥50%,” said trial investigator Ahmet Sezer, MD, of Baskent University in Turkey, in the release.
Sezer said the results could provide “valuable new clinical evidence that could enhance our understanding of how to treat this deadly cancer.”
Grade 3-4 treatment-emergent events occurred in 28% of patients treated with cemiplimab and 39% of patients treated with chemotherapy. Immune-mediated adverse events, including hypothyroidism, hyperthyroidism, and pneumonitis, were reported in 17% of patients in the drug arm and 2% in the chemo arm.
Cemiplimab’s use as a treatment for NSCLC “is investigational and has not been fully evaluated by any regulatory authority,” according to the release. Cemiplimab is currently approved in several countries as the first systemic treatment for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or radiation. The FDA has also approved cemiplimab as the first immunotherapy treatment for patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor or patients for whom the therapy is not appropriate.