114MO - First-line cemiplimab for locally advanced non-small cell lung cancer: Updated subgroup analyses from EMPOWER-Lung 1 and EMPOWER-Lung 3

Background

Patients (pts) with unresectable locally advanced non-small cell lung cancer (laNSCLC) who are not candidates for concurrent chemoradiation have often been excluded from immunotherapy trials, and their care represent an unmet medical need. We report post hoc analyses of pts with laNSCLC who received cemiplimab (anti–programmed cell death-1) from two phase III clinical trials with long-term data.

Methods

EMPOWER-Lung 1 and EMPOWER-Lung 3 included pts with squamous or non-squamous NSCLC that was metastatic or locally advanced (not suitable for definitive concurrent chemoradiation) without EGFR, ALK or ROS1 genomic aberrations. In EMPOWER-Lung 1 pts were randomised 1:1 to first-line (1L) cemiplimab monotherapy or chemo for NSCLC with ≥50% programmed cell death-ligand 1 (PD-L1) expression. In EMPOWER-Lung 3 pts were randomised 2:1 to 1L cemiplimab + chemo or placebo + chemo regardless of PD-L1 expression level.

Results

In each trial, 15% of pts were treated for laNSCLC. In EMPOWER-Lung 1, at ∼3-year follow-up of pts with laNSCLC, 1L cemiplimab monotherapy led to a median overall survival (OS) of 26.1 vs 13.9 mo with chemo (HR: 0.67; 0.38–1.17; p = 0.1532). Progression-free survival (PFS) was 8.1 vs 6.2 mo (HR: 0.56; 0.34–0.95; p = 0.0286). Objective response rate (ORR) was 49% vs 31%. Median duration of response (DOR) was 18.8 vs 6.2 mo. In EMPOWER-Lung 3, at ∼2-year follow-up of pts with laNSCLC, greater efficacy was observed with 1L cemiplimab + chemo vs placebo + chemo. Median OS was 24.1 vs 13.8 mo (HR: 0.50; 0.27–0.95; p = 0.0293) and median PFS was 12.5 vs 6.2 mo (HR: 0.34; 0.19–0.61; p = 0.0002). ORR was 58% vs 29%. Median DOR was 27.8 vs 4.2 mo.

^†PD-L1 ≥50% population. ^‡From randomization to data cutoff.

Conclusions

Long-term follow-up data from EMPOWER-Lung studies continue to suggest clinical benefit of 1L cemiplimab as monotherapy or in combination with platinum-based chemo in pts with unresectable laNSCLC who are not candidates for definitive concurrent chemoradiation.

Clinical trial identification

NCT03088540 and NCT03409614.

Editorial acknowledgement

Medical writing support was provided by Rachel McGrandle, MSc, 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.

Funding

Regeneron Pharmaceuticals, Inc. and Sanofi.

Disclosure

E. Kalinka: Financial Interests, Personal, Other, Honoraria: Amgen, AstraZeneca, Bristol-Meyers Squibb, Merck Sharp & Dohme, Nektar, Pfizer, Roche, Regeneron Pharmaceuticals, Inc. A. Sezer: Financial Interests, Institutional, Research Grant: Roche, Merck Sharp & Dohme, Merck Serono, AstraZeneca, Eli Lilly, Novartis, Johnson & Johnson, Regeneron Pharmaceuticals, Inc., Sanofi. M. Gumus: Financial Interests, Personal, Other, Honoraria: Roche, Merck Sharp & Dohme, Gen İlaç, Novartis. K.D. Penkov: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Merck Sharp & Dohme, Nektar, Pfizer, Regeneron Pharmaceuticals, Inc., Roche; Financial Interests, Personal, Advisory Role: Nektar. M. Özgüroğlu: Financial Interests, Personal, Other, Honoraria: Novartis, Roche, Janssen, Sanofi, Astellas; Financial Interests, Personal, Advisory Board: Janssen, Sanofi, Astellas; Financial Interests, Personal, Other, Travel support: Bristol-Myers Squibb, Janssen, AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca. X. He: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. J. Pouliot: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. F. Seebach: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. I. Lowy: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. G. Gullo: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. P. Rietschel: Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.