Cemiplimab Exhibits Long-Term Clinical Benefit in Advanced NSCLC Trial

Miranda Gogishvili, MD, spoke with CancerNetwork^® about the background and implications of a long-term analysis of findings from the phase 3 EMPOWER-Lung 1 trial (NCT03088540) assessing cemiplimab (Libtayo) monotherapy vs chemotherapy among patients with PD-L1–high advanced non–small cell lung cancer (NSCLC). According to Gogishvili, at the time of the trial’s launch, there was a need for additional chemotherapy-free options that could improve survival among those with high PD-L1 expression.

Gogishvili noted that updated results from EMPOWER-Lung 1 support the long-term clinical benefit of cemiplimab in this treatment setting. According to data presented at the 2026 European Lung Cancer Congress, the median overall survival (OS) was 26.1 months (95% CI, 22.1-31.9) with cemiplimab vs 13.3 months (95% CI, 10.5-16.2) with chemotherapy, with respective 72-month OS rates of 23.8% vs 13.5% (HR, 0.601; 95% CI, 0.492-0.735; P <.0001).

At 6 years, the safety profile of cemiplimab in the EMPOWER-Lung 1 trial was comparable with prior reports, as investigators observed no new safety signals. Grade 3 or higher treatment-emergent adverse effects occurred in 45.8% of the cemiplimab arm and 51.6% of the chemotherapy arm.

Gogishvili is a medical oncologist from Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic in Tbilisi, Georgia.

Transcript:

Anti–PD-(L)1 inhibitors have become a critical component of the systemic treatment of advanced NSCLC without EGFR, ALK, or ROS1 aberrations. At the time the EMPOWER-Lung 1 trial was initially designed, there was a need for additional treatment options that improved survival benefits and optimized chemotherapy-free treatments in patients with high PD-L1 expression, with only 1 agent in this class having shown superiority over chemotherapy. Therefore, the EMPOWER-Lung 1 study was designed to assess the clinical benefit of cemiplimab monotherapy in newly diagnosed patients with advanced NSCLC with PD-L1 expression of 50% of or more and no EGFR, ALK, or ROS1 aberrations to hopefully better understand the real magnitude of benefit of anti–PD-1 monotherapy compared with chemotherapy.

These findings validate a long-term clinical benefit of cemiplimab first-line monotherapy in [patients with] PD-L1–high advanced NSCLC. [They] reinforce the value of long-term immune checkpoint inhibition.

Reference

Gogishvili M, Kilickap S, Baramidze A, et al. Cemiplimab monotherapy for first-line advanced NSCLC patients with PD-L1 expression ≥50%: 6-y outcomes of EMPOWER-Lung 1. Presented at: 2026 European Lung Cancer Congress; March 25-28, 2026; Copenhagen, Denmark. Abstract 72P.