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NSCLC, metastatic 1

3622 - Updated results from KEYNOTE-021 cohort G: a randomized, phase 2 study of pemetrexed and carboplatin (PC) with or without pembrolizumab (pembro) as first-line therapy for advanced nonsquamous NSCLC


08 Sep 2017


NSCLC, metastatic 1


Cytotoxic Therapy;  Immunotherapy;  Non-Small Cell Lung Cancer


Hossein Borghaei


Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440


H. Borghaei1, C.J. Langer2, S. Gadgeel3, V.A. Papadimitrakopoulou4, A. Patnaik5, S.F. Powell6, R.D. Gentzler7, R.G. Martins8, J.P. Stevenson9, S.I. Jalal10, A. Panwalkar11, J.C. Yang12, M. Gubens13, L. Sequist14, M.M. Awad15, J. Fiore16, S. Saraf16, H. Raftopoulos16, L. Gandhi17

Author affiliations

  • 1 Hematology And Oncology, Fox Chase Cancer Center, 19111-2497 - Philadelphia/US
  • 2 Department Of Medicine, Abramson Cancer Center, 19104 - Philadelphia/US
  • 3 Thoracic Oncology, Karmanos Cancer Institute, 48201-2013 - Detroit/US
  • 4 Thoracic/head & Neck Oncology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 5 Clinical Research, South Texas Accelerated Research Therapeutics (START), 78229 - San Antonio/US
  • 6 Oncology, Sanford Heath, 57105 - Sioux Falls/US
  • 7 Hematology/oncology, University of Virginia, 22903 - Charlottesville/US
  • 8 Medicine, University of Washington, 98109 - Seattle/US
  • 9 Taussig Cancer Institute, Cleveland Clinic, Cleveland/US
  • 10 Internal Medicine, Indiana University School of Medicine, 46202 - Indianapolis/US
  • 11 Hematology/oncology, Sanford Roger Maris Cancer Center, Fargo/US
  • 12 Department Of Oncology, National Taiwan University Hospital, 100 - Taipei/TW
  • 13 Medical Oncology, University of California, San Francisco, San Francisco/US
  • 14 Hematology/oncology, Massachusetts General Hospital, 2114 - Boston/US
  • 15 Thoracic Oncology, Dana-Farber Cancer Institute, Boston/US
  • 16 Clinical Research, Merck & Co., Inc., Kenilworth/US
  • 17 Laura And Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York/US


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Abstract 3622


Cohort G of the multicenter, open-label, phase 1/2 KEYNOTE-021 study evaluated the efficacy and safety of pembro + PC vs PC alone as first-line therapy for advanced nonsquamous NSCLC. At the primary analysis of cohort G (min. follow-up, 6 mo; median, 10.6 mo), pembro significantly improved ORR (estimated treatment difference, 26%; P = 0.0016) and PFS (HR, 0.53; P = 0.010). The HR for OS was 0.90 (95% CI, 0.42–1.91). In a subsequent analysis with median follow-up of 14.5 mo, the HR for OS was 0.69 (95% CI, 0.36–1.31).


123 patients with stage IIIB/IV nonsquamous NSCLC, no prior systemic therapy, and no EGFR mutation or ALK translocation were randomized 1:1 (stratified by PD-L1 TPS ≥1% vs 


At the time of data cutoff (May 31, 2017), median follow-up was 18.7 mo (range, 0.8–29.0 mo). ORR was 57% with pembro + PC and 32% with PC (estimated difference, 25%; 95% CI, 7%–41%; P = 0.0029). PFS was significantly improved with pembro + PC vs PC (HR, 0.54; 95% CI, 0.33–0.88; P = 0.0067) with median (95% CI) PFS of 19.0 (8.5–NR) mo vs 8.9 (95% CI, 6.2–11.8) mo. 40 of 53 (75%) patients in the PC arm who discontinued received subsequent anti-PD-1/anti-PD-L1 therapy (including 25 who received pembro in the on-study cross over). The HR for OS was 0.59 (95% CI, 0.34–1.05; P = 0.0344). Median (95% CI) OS was not reached (22.8–NR) mo for pembro + PC and 20.9 (14.9–NR) mo in the PC arm. 18-mo OS rate was 70% with pembro + PC and 56% with PC. Grade 3–5 treatment-related AEs occurred in 41% of patients in the pembro + PC arm vs 29% in the PC arm.


The significant improvements in PFS and ORR with pembro + PC vs PC first observed in the primary analysis have been maintained with longer follow-up (median 18.7 mo). The HR for OS continues to improve for pembro + PC vs PC (HR: 0.90 to 0.69 to 0.59).

Clinical trial identification


Legal entity responsible for the study

Merck & Co., Inc.


This research was supported by Merck & Co., Inc.


H. Borghaei: Advisory board member: BMS, Lilly, Celgene, Genenetch, Novartis, Astra Zeneca, Trovagene, EMD-Serono, Pfizer, Merck Research funding: Celgene, Millennium, Merck Honoraria: Celgene Travel expenses, including accommodations: BMS, Lilly, Celgene, Genenetch, Novartis, Astra Zeneca, Trovagene, EMD-Serono, Pfizer, Merck, Millennium. C.J. Langer: Research funding: Merck, GSK, Advantagene, Inovio, Clovis DSMC: Synta, AbbVie, Amgen, Lilly Advisory board member: AZ, BMS, Genetech/Roche, Clovis S. Gadgeel: Advisory board member: Pfizer, AstraZeneca, Genentech-Roche, Ariad, Briston-Myers Squibb, Novartis Honoraria: Genentech-Roche, AstraZeneca. V.A. Papadimitrakopoulou: Advisory board member: Bristol-Myers Squibb, AstraZeneca, Celgene, Janssen, Merck, OncLive, Genentech, Merck & Co., Inc., Araxes Pharma, LLC, Nektar Therapeutics, Takeda Pharmaceuticals, Eli Lilly & Co Speaker\'s bureau: Creative Educational Concepts (CEC Oncology) Research funding: Merck & Co., Inc., NIH/NCI, Bristol-Myers Squibb, Oregon Health Science University, Cancer Prevention & Research Institute of Texas (CPRIT), American Association for Cancer Research (AACR) A. Patnaik: Research funding: Merck. S.F. Powell: Research funding: Merck, Bristol-Myers Squibb, Incyte, Genentech, Novartis, Pfizer R.D. Gentzler: Advisory board member: Bristol-Myers Squibb, Takeda Oncology Research funding: Merck, Celgene, Bristol-Myers Squibb Honoraria: Merck. J.P. Stevenson: Research funding: Merck & Co., Inc., Bristol-Myers Squibb, Bayer Healthcare S.I. Jalal: Research funding: Astrazeneca. J.C-H. Yang: Advisory board member: Boehringer Ingeheim, Eli Lilly, Bayer, Roche/Genetech/Chugai, Astellas, MSD, Merck Serono, Pfizer, Novartis, Clovis Oncology, Celgene, Merrimack, Yuhan Pharmaceutical, BMS, Ono Pharmaceutical, AstraZeneca. M. Gubens: Advisory board member: AbbVie, ARIAD, AstraZeneca, BMS, Genentech/Roche, Mersana, Novartis Research funding: Celgene, Merck, Novartis, OncoMed, Roche L. Sequist: Advisory board member: AstraZeneca, BMS, Aviad, Genentech Research funding: Clovis, Novartis, BI, Merrimack, Merck, AstraZeneca Travel expenses: AstraZeneca. M.M. Awad: Consulting: Merck, BMS, Genentech. J. Fiore, S. Saraf, H. Raftopoulos: Employment: Merck & Co., Inc. L. Gandhi: Advisory board member: Genentech/Roche, Merck Research funding: BMS IION Foundation All other authors have declared no conflicts of interest.

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