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Proffered Paper - NSCLC metastatic 2

LBA52 - EMPOWER-Lung 1: Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%

Date

21 Sep 2020

Session

Proffered Paper - NSCLC metastatic 2

Presenters

Ahmet Sezer

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

A. Sezer1, S. Kilickap2, M. Gümüş3, I. Bondarenko4, M. Özgüroğlu5, M. Gogishvili6, H.M. Turk7, İ. Çiçin8, D. Bentsion9, O. Gladkov10, P. Clingan11, V. Sriuranpong12, N. Rizvi13, S. Li14, S. Lee14, G. Gullo15, I. Lowy15, P. Rietschel15

Author affiliations

  • 1 Department Of Medical Oncology, Başkent University, 1120 - Adana/TR
  • 2 Department Of Medical Oncology, Hacettepe University Cancer Institute, 06100 - Ankara/TR
  • 3 Department Of Medical Oncology, School of Medicine, Istanbul Medeniyet University, Istanbul/TR
  • 4 Department Of Oncology And Medical Radiology, Dnipropetrovsk Medical Academy, Dnipropetrovsk Oblast/UA
  • 5 Cerrahpaşa Medical Faculty, Istanbul University-Cerrahpaşa, Istanbul/TR
  • 6 High Technology Medical Centre, University Clinic Ltd, Tbilisi/GE
  • 7 Department Of Medical Oncology, Bezmialem Vakif University, Medical Faculty, Istanbul/TR
  • 8 Department Of Medical Oncology, Trakya University, 22020 - Edirne/TR
  • 9 Radiotherapy Department, Sverdlovsk Regional Oncology Centre, Sverdlovsk/RU
  • 10 Llc, “EVIMED", Chelyabinsk/RU
  • 11 Southern Medical Day Care Centre And Illawarra Health And Medical Research Institute, University of Wollongong/Illawarra Cancer Centre, Wollongong Hospital, Wollongong/AU
  • 12 Division Of Medical Oncology, Department Of Medicine, Faculty Of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, 10330 - Bangkok/TH
  • 13 Division Of Hematology/oncology, Columbia University Medical Center, 10032 - New York/US
  • 14 Clinical Sciences, Regeneron Pharmaceuticals, Inc., Basking Ridge/US
  • 15 Clinical Sciences, Regeneron Pharmaceuticals, Inc., Tarrytown/US
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Resources

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Abstract LBA52

Background

EMPOWER-Lung 1 is a multicentre, open-label, global, phase III study of cemiplimab, an anti–PD-1, in patients (pts) with treatment-naïve stage IIIB, IIIC, or IV squamous or non-squamous NSCLC with PD-L1 expressed in ≥50% of tumour cells.

Methods

Pts were randomised 1:1 to receive cemiplimab 350 mg Q3W IV or investigator’s choice of chemo. Crossover (CO) from chemo to cemiplimab was allowed following progression. The primary endpoints were overall survival (OS) and progression-free survival (PFS) per blinded Independent Review Committee. A prespecified interim analysis was performed after 50% of OS events. Data are presented per intention-to-treat (ITT) and in a PD-L1 ≥50% ITT population which comprised only pts with PD-L1 ≥50% by 22C3 per instruction for use (after recommended retesting in some pts). Data cut-off was 1 March 2020.

Results

In the ITT population (median follow-up: 13.1 months), median OS was 22.1 months (95% CI: 17.7–not evaluable [NE]) with cemiplimab (n=356) vs 14.3 months (95% CI: 11.7–19.2) with chemo (n=354; HR, 0.68; 95% CI: 0.53–0.87; P=0.002). Median PFS was 6.2 months (95% CI: 4.5–8.3) with cemiplimab vs 5.6 months (95% CI: 4.5–6.1) with chemo (HR, 0.59; 95% CI: 0.49–0.72; P<0.0001). In the PD-L1 ≥50% ITT population (median follow-up: 10.8 months), median OS was not reached (95% CI: 17.9–NE) with cemiplimab (n=283) vs 14.2 months (95% CI: 11.2–17.5) with chemo (n=280; HR, 0.57; 95% CI: 0.42–0.77; P=0.0002). Median PFS was 8.2 months (95% CI: 6.1–8.8) with cemiplimab vs 5.7 months (95% CI: 4.5–6.2) with chemo (HR, 0.54; 95% CI: 0.43–0.68; P<0.0001). CO rate to cemiplimab was 73.9%. In the ITT population, cemiplimab was associated with higher response rate (36.5% vs 20.6%), longer median duration of response (21.0 months vs 6.0 months) and lower rates of Grade ≥3 adverse events regardless of attribution (37.2% vs 48.5%) compared to chemo.

Conclusions

In this study, 1L cemiplimab monotherapy significantly improved OS and PFS vs chemo in pts with advanced NSCLC with PD-L1 ≥50%, despite high CO rate, providing rationale for cemiplimab as a new treatment option for this patient population.

Clinical trial identification

NCT03088540.

Editorial acknowledgement

Medical writing support was provided by Emmanuel Ogunnowo, PhD 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

A. Sezer: Research grant/Funding (institution): Roche; Research grant/Funding (self): MSD Oncology; Research grant/Funding (self): Regeneron Pharmaceuticals, Inc.; Research grant/Funding (self): Novartis; Travel/Accommodation/Expenses: Bristol-Myers Squibb; Research grant/Funding (institution): Merck Serono; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Lily; Research grant/Funding (institution): Johnson & Johnson; Research grant/Funding (institution): Sanofi. M. Gümüş: Honoraria (institution), outside the submitted work: Roche; Honoraria (institution), outside the submitted work: Merck Sharp & Dohme; Honoraria (institution), outside the submitted work: Gen İlaç; Honoraria (institution), outside the submitted work: Novartis. N. Rizvi: Advisory/Consultancy, outside the submitted work: AbbVie; Advisory/Consultancy, outside the submitted work: Apricity; Advisory/Consultancy, outside the submitted work: AstraZeneca; Advisory/Consultancy, outside the submitted work: Boehringer; Advisory/Consultancy, outside the submitted work: Calithera; Advisory/Consultancy, outside the submitted work: Dracen; Advisory/Consultancy, outside the submitted work: Editas; Advisory/Consultancy, outside the submitted work: EMD Sorono; Advisory/Consultancy, outside the submitted work: G1 Therapeutics; Advisory/Consultancy, outside the submitted work: Genentech; Advisory/Consultancy, outside the submitted work: Gilead; Advisory/Consultancy, outside the submitted work: GSK; Advisory/Consultancy, outside the submitted work: Illumina; Advisory/Consultancy, outside the submitted work: Lilly; Advisory/Consultancy, outside the submitted work: Merck; Advisory/Consultancy, outside the submitted work: Neogenomics; Advisory/Consultancy, outside the submitted work: Novartis; Advisory/Consultancy, Shareholder/Stockholder/Stock options, outside the submitted work: Brooklyn ImmunoTherapeutics; Advisory/Consultancy, outside the submitted work: Takeda; Advisory/Consultancy, Shareholder/Stockholder/Stock options, outside the submitted work: Bellicum; Licensing/Royalties, Patent (pending) filed by MSKCC, in the form of royalties, on “determinants of cancer response to immunotherapy, (PCT/US2015/062208)” licensed to Personal Genome Diagnostics: Personal Genome Diagnostics; Shareholder/Stockholder/Stock options, outside the submitted work: Gritstone. S. Li, S. Lee, G. Gullo: Shareholder/Stockholder/Stock options, Full/Part-time employment: Regeneron Pharmaceuticals, Inc. I. Lowy, P. Rietschel: Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment, Patents pending: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.

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