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.
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.
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.
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.
NCT03088540.
Medical writing support was provided by Emmanuel Ogunnowo, PhD of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi.
Regeneron Pharmaceuticals, Inc. and Sanofi.
Regeneron Pharmaceuticals, Inc. and Sanofi.
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.