Cemiplimab Shows Real-World Efficacy in Advanced NSCLC Study

In the interim analysis of the CEMI-LUNG study (NCT05363319) evaluating cemiplimab (Libtayo) monotherapy among 211 patients with advanced non–small cell lung cancer (NSCLC), median overall survival (OS) was not reached (95% CI, 22.2-not evaluable), with 54.9% of patients alive at 30 months. Additionally, the median progression-free survival (PFS) 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%).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 how these real-world efficacy findings compared with outcomes seen in pivotal studies like the EMPOWER-Lung 1 trial (NCT03088540). Data from the CEMI-Lung trial, he noted, provide complementary evidence of cemiplimab’s real-world benefits in NSCLC management.

Other data revealed that among 211 evaluable patients in the cemiplimab monotherapy cohort, 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% had IMAEs associated with death. The most common IMAEs included diarrhea (4.3%), hypothyroidism (3.3%), and pneumonitis (3.3%).

Transcript:

CancerNetwork: What were the key efficacy findings, and how did outcomes like response rate, progression-free survival, or overall survival compare with what was seen in the pivotal trials?

Corral Jaime: The CEMI-LUNG trial’s key endpoints include overall survival, progression-free survival, and overall response rate. As the primary end point, median overall survival was not reached; almost 55% of patients were alive at 30 months. Secondary end points include progression-free survival, with a median of 7.6 months, and an overall response rate of 37.4%.

In my opinion, these preliminary cemiplimab monotherapy results from the CEMI-LUNG trial that we presented at ESMO provide complementary evidence of benefit from a real-world data population with cemiplimab monotherapy.

Reference

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.