Real-World Data on Cemiplimab Monotherapy Align With Prior NSCLC Studies

Investigators of the CEMI-LUNG study (NCT05363319) enrolled an unselected, real-world population of more than 200 patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) and high PD-L1 expression, a group that was older and had more comorbidities than those typically enrolled in pivotal trials.¹

Jesus Corral Jaime, MD, of Hospital Universitario de Jerez in Spain, who presented these findings at the 2026 European Society for Medical Oncology (ESMO) Congress, spoke with CancerNetwork^® about the practical takeaway he wants community oncologists to walk away with when deciding how to use cemiplimab monotherapy in advanced NSCLC today. He noted that different efficacy outcomes were comparable to those observed in the phase 3 EMPOWER-Lung 1 trial (NCT03088540), supporting the real-world use of single-agent immunotherapy in this NSCLC population.²

According to efficacy data shared at ESMO, among 211 evaluable patients with advanced NSCLC, the median overall survival was not reached (95% CI, 22.2-not evaluable), with 54.9% of patients alive at 30 months. Additionally, the median progression-free survival was 7.6 months (95% CI, 5.5-10.3), and the objective response rate (ORR) was 37.4% (95% CI, 30.9%-44.4%).

Among 211 patients in the cemiplimab monotherapy cohort who were evaluable for safety, 19.9% of patients experienced at least 1 immune-mediated adverse effect (IMAE), which included 4.7% with grade 3 or higher events. IMAEs resulted in study treatment discontinuation in 2.8% of patients, and 0.9% experienced IMAEs associated with death. The most common IMAEs included diarrhea (4.3%), hypothyroidism (3.3%), and pneumonitis (3.3%).

Transcript:

CancerNetwork: What practical takeaway from CEMI-LUNG would you want a community oncologist to walk away with when deciding how to use cemiplimab in advanced NSCLC today?

Corral Jaime: CEMI-LUNG enrolled more than 200 unselected patients with locally advanced or metastatic [NSCLC] and high PD-L1 expression. Cemiplimab monotherapy showed efficacy results in terms of overall survival, progression-free survival, and overall response rate that were very consistent with data reported in the EMPOWER-Lung1 study.²

In my opinion, this study supports the benefit of immunotherapy [alone] with cemiplimab for treating advanced non–small cell lung cancer in real-world practice.

References

1. Corral Jaime J, Bironzo P, Mascaux C, et al. CEMI-LUNG: a European real-world observational study of cemiplimab monotherapy in advanced non-small cell lung cancer, including effectiveness, safety and patient-reported outcomes. Presented at: European Society for Medical Oncology (ESMO) Congress 2026; October 23-27, 2026; Madrid, Spain. Poster 2580P.
2. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274):592-604. doi:10.1016/S0140-6736(21)00228-2