1438P - Cemiplimab for advanced non-small cell lung cancer: Squamous subgroup analysis for EMPOWER-Lung 1 and 3

Background

Outcomes for patients (pts) with squamous non-small cell lung cancer (NSCLC) treated with immunotherapy are generally poorer than pts with non-squamous NSCLC and have fewer treatment options. We report an exploratory subgroup analysis of pts with squamous NSCLC who were treated with cemiplimab from two phase 3 clinical trials.

Methods

EMPOWER-Lung 1 (NCT03088540) and EMPOWER-Lung 3 (NCT03409614; part 2) included pts with squamous or non-squamous advanced NSCLC without EGFR, ALK or ROS1 aberrations. In EMPOWER-Lung 1, pts with ≥50% programmed cell death-ligand 1 (PD-L1) were randomized 1:1 to first-line (1L) cemiplimab monotherapy or platinum-doublet chemotherapy (chemo). In EMPOWER-Lung 3, pts irrespective of PD-L1 level were randomized 2:1 to 1L cemiplimab + chemo or placebo + chemo.

Results

In both trials, ∼43% of pts had squamous histology. In EMPOWER-Lung 1, at median follow-up of 37.1 mo, for squamous pts treated with cemiplimab vs chemo, median overall survival (OS) was 22.7 vs 13.5 mo (HR: 0.51; 95% CI: 0.37, 0.69), and median progression-free survival (PFS) was 8.3 vs 5.9 mo (HR: 0.44; 95% CI: 0.32, 0.59). The objective response rate (ORR) was 43.9% vs 22.1%, and the median duration of response (DOR) was 16.0 mo (95% CI: 10.4, 33.0) vs 4.3 mo (95% CI: 4.2, 6.1), respectively. In EMPOWER-Lung 3 part 2, at a median follow-up of 28.4 mo, for squamous pts treated with cemiplimab + chemo vs placebo + chemo, median OS was 22.3 vs 13.8 mo (HR: 0.61; 95% CI: 0.42, 0.87), and median PFS was 8.2 vs 4.9 mo (HR: 0.56; 95% CI: 0.41, 0.78). ORR was 46.6% vs 26.9%, and the median DOR was 13.8 mo (95% CI: 11.0,18.2) vs 11.3 mo (95% CI: 4.2, 21.4), respectively. Patient reported outcomes and safety results will be described for both studies in the presentation.

Conclusions

Subgroup analysis with long-term follow up data from two large phase 3 studies demonstrate improved clinical benefit of cemiplimab as 1L monotherapy or in combination with platinum-doublet chemo over chemo alone in pts with squamous NSCLC. Table: 1438P

^†PD-L1 ≥50% population. Data cutoff dates: EMPOWER-Lung 1: 4 Mar 2022; EMPOWER-Lung 3 Part 2: 14 June 2022.

Clinical trial identification

NCT03088540; NCT03409614.

Editorial acknowledgement

Medical writing support was provided by John Facciponte, PhD, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc.

Funding

Regeneron Pharmaceuticals, Inc., and Sanofi.

Disclosure

A. Sezer: Financial Interests, Institutional, Research Grant: Roche, Merck Sharp & Dohme, Merck Serono, AstraZeneca, Lilly, Novartis, Johnson & Johnson, Regeneron Pharmaceuticals, Inc., Sanofi. S. Kilickap: Financial Interests, Personal, Other, Travel support: Regeneron. M. Gumus: Financial Interests, Institutional, Invited Speaker: Pfizer, Gen Pharmaceuticals, Novartis, Bayer; Financial Interests, Institutional, Advisory Board: Amgen, Roche, BMS, AstraZeneca; Financial Interests, Institutional, Coordinating PI: Amgen; Financial Interests, Institutional, Local PI: Jounce Therapeutics. K.D. Penkov: Financial Interests, Personal, Advisory Board: Nektar Therapeutics; Financial Interests, Personal and Institutional, Local PI: AbbVie, AstraZeneca, Pfizer, Jounce Therapeutics, Polyphor, GSK, Mabscale, Biocad, Sanofi, Novartis, Regeneron Pharmaceutical. M. Ozguroglu: Financial Interests, Personal, Advisory Board, prostate cancer: Astellas; Financial Interests, Personal, Invited Speaker, travel and accommodation: Regeneron; Financial Interests, Personal, Advisory Board, lung cancer meeting: Sanofi. E. Kalinka: Financial Interests, Personal, Advisory Board, advisory board member, clinical trial and lectures honoraria: Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker, lectures and clinical trial honoraria: Merck Sharp and Dohme; Financial Interests, Personal, Invited Speaker, lectures honoraria: GSK, Roche; Financial Interests, Personal, Invited Speaker, lectures honoraria and writing engagement: Sanofi, Regeneron; Financial Interests, Personal, Advisory Board, advisory role, clinical trials honoraria: AstraZeneca; Financial Interests, Personal, Invited Speaker: Gilead, Amgen; Financial Interests, Personal, Ownership Interest: Instytut MSF Sp zoo; Financial Interests, Personal and Institutional, Local PI: AstraZeneca, Roche, Bristol Myers Squibb, Gilead; Financial Interests, Personal, Local PI: Merck Sharp Dohme. D. McIntyre, M. Kaul, R.G.W. Quek, J. Pouliot, F. Seebach, G. Gullo, P. Rietschel: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.