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Mini oral session - NSCLC, metastatic

LBA51 - EMPOWER-Lung 3: Cemiplimab in combination with platinum doublet chemotherapy for first-line (1L) treatment of advanced non-small cell lung cancer (NSCLC)

Date

19 Sep 2021

Session

Mini oral session - NSCLC, metastatic

Presenters

Miranda Gogishvili

Citation

Annals of Oncology (2021) 32 (suppl_5): S1283-S1346. 10.1016/annonc/annonc741

Authors

M. Gogishvili1, T. Melkadze2, T. Makharadze3, D. Giorgadze4, M. Dvorkin5, K.D. Penkov6, K. Laktionov7, G. Nemsadze8, M. Nechaeva9, I. Rozhkova10, E. Kalinka11, C. Gessner12, B. Moreno-Jaime13, R. Passalacqua14, S. Li15, K. McGuire15, R.G.W. Quek15, G. Gullo15, P. Rietschel15

Author affiliations

  • 1 High Technology Medical Centre, University Clinic Ltd, 0144 - Tbilisi/GE
  • 2 N/a, Georgia Medical Institute, Jonesboro/US
  • 3 N/a, LTD High Technology Hospital Med Center, Batumi/GE
  • 4 Oncological Concilium Group, David Tvildiani Medical University, Tbilisi/GE
  • 5 N/a, State Budgetary Healthcare Institution of Omsk Region, Omsk/RU
  • 6 General, Private Medical Institution Euromedservice, 196603 - St Petersburg/RU
  • 7 Federal State Budgetary Institution "n.n.blokhin National Medical Research Center Of Oncology”, Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow/RU
  • 8 N/a, The Institute of Clinical Oncology, Tbilisi/GE
  • 9 N/a, Chelyabinsk Regional Clinical Oncology Center, Chelyabinsk/RU
  • 10 N/a, State Budgetary Healthcare Institution of Kaluga Region, Kaluga/RU
  • 11 Research Lnstitute, Polish Mother’s Memorial Hospital, Łódź/PL
  • 12 N/a, POIS Leipzig GbR Steffi Geßner, Leipzig/DE
  • 13 N/a, Col. Lomas del Campestre, Lomas del Campestre/MX
  • 14 N/a, Istituti Ospitalieri Di Cremona, Cremona/IT
  • 15 N/a, Regeneron Pharmaceuticals, Inc., Tarrytown/US
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Resources

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Abstract LBA51

Background

EMPOWER-Lung 3 is a randomised, 2-part, Phase 3 study of 1L treatment of patients (pts) with advanced (Stage III/IV) squamous (SQ) or non-squamous (NSQ) NSCLC without actionable mutations (NCT03409614). The double-blind Part 2 of the study enrolled pts irrespective of PD-L1 levels and compared clinical activity and safety of cemiplimab, an anti -PD-1, plus (+) platinum-based chemo, versus (vs) placebo (PBO)+chemo.

Methods

Pts were randomised (2:1; stratified by histology and PD-L1 expression) to receive cemiplimab 350 mg once every 3 weeks (Q3W) or PBO Q3W for 108 weeks (or until progression), plus up to 4 cycles of chemo (followed by mandatory pemetrexed maintenance for NSQ pts assigned to a pemetrexed-containing regimen). Primary endpoint was overall survival (OS). Key secondary endpoints include progression-free survival (PFS) and objective response rate (ORR) per blinded independent central review. Here we report Part 2 results from the pre-specified 2nd interim analysis. Data cut-off was 14 June 2021.

Results

Overall, 466 pts were eligible and randomised to cemiplimab+chemo (n=312) or PBO+chemo (n=154). Median (range) age was 63.0 (25-84) years; 57.1% had NSQ NSCLC; and 85.2% had Stage IV disease. Median OS was 21.9 months with cemiplimab+chemo vs 13.0 months with PBO+chemo (HR, 0.71; P=0.014). Cemiplimab+chemo was associated with superior median PFS (8.2 vs 5.0 months; HR, 0.56), higher ORR (43.3% vs 22.7%), and longer median duration of response (DOR) (15.6 months vs 7.3 months) vs PBO+chemo (Table). Incidence of Grade ≥3 adverse events was 43.6% in cemiplimab+chemo arm and 31.4% in PBO+chemo arm. Table: LBA51

Cemiplimab+chemo (n=312) PBO+chemo (n=154)
Duration of follow-up, median (IQR), months 16.3 (13.9–19.1) 16.7 (14.2–19.0)
OS, median (95% CI), months 21.9 (15.5–NE) 13.0 (11.9–16.1)
HR (95% CI) 0.71 (0.53–0.93); P=0.014
PFS, median (95% CI), months 8.2 (6.4–9.3) 5.0 (4.3–6.2)
HR (95% CI) 0.56 (0.44–0.70); P<0.0001
ORR, % (95% CI) 43.3 (37.7–49.0) 22.7 (16.4–30.2)
Odds ratio (95% CI) 2.68 (1.72–4.19); P<0.0001
Complete response, n (%) 8 (2.6) 0 (0)
Partial response, n (%) 127 (40.7) 35 (22.7)
Kaplan-Meier estimated DOR, median (95% CI), months 15.6 (12.4–NE) 7.3 (4.3–12.6)

Conclusions

In pts with advanced NSCLC, 1L cemiplimab+chemo demonstrated clinically meaningful and statistically significant improvement in OS, PFS, ORR and DOR vs chemo alone, with a safety profile consistent with cemiplimab monotherapy and platinum-based chemo.

Clinical trial identification

NCT03409614.

Editorial acknowledgement

Medical writing support was provided by Jenna Lee, MS, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc. and Sanofi.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc., and Sanofi.

Funding

Regeneron Pharmaceuticals, Inc., and Sanofi.

Disclosure

K.D. Penkov: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Nektar; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Regeneron Pharmaceuticals, Inc; Financial Interests, Personal, Advisory Role: Roche. E. Kalinka: Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Bristol Myers Squibb; Financial Interests, Personal, Advisory Role: Nektar; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: Regeneron Pharmaceuticals. C. Gessner: Financial Interests, Personal, Other, Advisory board fees or honoraria: GlaxoSmithKline; Financial Interests, Personal, Other, Advisory board fees or honoraria: Pfizer; Financial Interests, Personal, Other, Advisory board fees or honoraria: AstraZeneca; Financial Interests, Personal, Other, Advisory board fees or honoraria: Roche; Financial Interests, Personal, Other, Advisory board fees or honoraria: Novartis; Financial Interests, Personal, Other, Advisory board fees or honoraria: Bristol Myers Squibb; Financial Interests, Personal, Other, Advisory board fees or honoraria: Merck Sharp & Dohme; Financial Interests, Personal, Other, Advisory board fees or honoraria: Berlin-Chemie; Financial Interests, Personal, Other, Advisory board fees or honoraria: Chiesi; Financial Interests, Personal, Other, Advisory board fees or honoraria: Boehringer Ingelheim; Financial Interests, Personal, Other, Advisory board fees or honoraria: Sanofi. R. Passalacqua: Financial Interests, Personal, Advisory Role: Astellas; Financial Interests, Personal, Advisory Role: Bristol Myers Squibb; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Sanofi-Aventis; Financial Interests, Institutional, Funding: Amgen; Financial Interests, Institutional, Funding: AstraZeneca; Financial Interests, Institutional, Funding: Novartis; Financial Interests, Institutional, Funding: Pierre-Fabre. S. Li: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. K. McGuire: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. R.G.W. Quek: 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, 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.

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