1495P - Cemiplimab plus chemotherapy versus chemotherapy in non-small cell lung cancer with PD-L1 ≥1%: EMPOWER-Lung 3 results

Background

In EMPOWER-Lung 3 (NCT03409614; Part 2), a randomised, double-blind, placebo-controlled phase 3 trial, cemiplimab + chemotherapy (chemo) versus chemo alone showed improved overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and patient-reported outcomes (PRO) and an acceptable safety profile in patients with advanced squamous and non-squamous non-small cell lung cancer (NSCLC) with all levels of programmed cell death-ligand 1 (PD-L1) expression and without EGFR, ALK or ROS1 aberrations. Cemiplimab + chemo received FDA approval in 2022 as first-line treatment for advanced NSCLC irrespective of PD-L1 levels. In 2023, it received European Commission approval for PD-L1–positive patients. Here we describe outcomes for patients with PD-L1 expression ≥1% from EMPOWER-Lung 3 Part 2. PRO and subgroup results will be further described in the presentation.

Methods

A total of 466 patients were randomised 2:1 to receive 4 cycles of platinum-doublet chemo in combination with cemiplimab 350 mg (n=312) or with placebo (n=154) every 3 weeks up to 108 weeks. The primary endpoint was OS. Secondary endpoints included PFS and ORR. This post hoc analysis included patients with PD-L1 ≥1% with ∼2-year follow-up data (cutoff 14 June 2022).

Results

In 327 patients with PD-L1 ≥1%, median OS was longer with cemiplimab + chemo than chemo alone (23.5 vs 12.1 months; HR: 0.52, P<0.0001). Median PFS was 8.3 months with cemiplimab + chemo versus 5.5 months with chemo alone (HR: 0.47, P<0.0001). ORRs were 47.9% vs 22.7%, with a response duration of 17.5 and 6.5 months. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 48.4% of patients with cemiplimab + chemo versus 27.5% with chemo alone. The safety profile for cemiplimab + chemo in patients with PD-L1 ≥1% was generally consistent with that in overall patients. Table: 1495P

Conclusions

Cemiplimab + chemo showed improved efficacy compared with chemo alone in PD-L1–positive patients with advanced NSCLC.

Clinical trial identification

NCT03409614; Part 2.

Editorial acknowledgement

Editorial support was provided by Fiona Nitsche, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Responsibility for all opinions, conclusions, and data interpretation lies with the authors.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc., and Sanofi.

Funding

This study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi.

Disclosure

K.D. Penkov: Financial Interests, Personal, Other, Honoraria: AstraZeneca, BeiGene, GSK, H3 Biomedicine, Janssen, Nektar, Novartis, Pfizer, Regeneron, Sanofi. E. Kalinka: Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme, Bristol Myers Squibb, Nektar, Pfizer, Roche, AstraZeneca, Amgen, Regeneron; Financial Interests, Personal, Other, Travel support: Sanofi. D. McIntyre, M. Kaul, R.G.W. Quek, J. Pouliot, F. Seebach, G. Gullo, P. Rietschel: Financial Interests, Personal and Institutional, Full or part-time Employment: Regeneron. All other authors have declared no conflicts of interest.