Author of

• 20039

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  Poster Display Session (ID 63)

  • Event: ELCC 2017
  • Type: Poster Display Session
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1

  • 19900

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    144TiP - CheckMate 227: A randomized, open-label phase 3 trial of nivolumab, nivolumab plus ipilimumab, or nivolumab plus chemotherapy versus chemotherapy in chemotherapy-naïve patients with advanced non-small cell lung cancer (NSCLC) (ID 394)

    12:30 - 13:00  |  Author(s): M.D. Hellmann
    • Abstract

    Background:
    Platinum-based chemotherapy is standard-of-care first-line therapy for most patients with advanced NSCLC, but the clinical benefit is modest. Although first-line nivolumab, an immune checkpoint inhibitor antibody, did not improve progression-free survival or overall survival (OS) versus chemotherapy in patients with advanced NSCLC and ≥5% programmed death-1 ligand 1 (PD-L1) expression, OS compared favorably with historical controls of first-line platinum-based chemotherapy. Combining nivolumab with chemotherapy in this setting may increase the durability of tumor responses and broaden the population of patients to derive benefit. In a multi-cohort phase 1 study (CheckMate 012) in chemotherapy-naïve patients with advanced NSCLC, nivolumab plus chemotherapy had promising clinical activity, regardless of tumor PD-L1 expression, and a manageable safety profile. CheckMate 227 is a 2-part, randomized, open-label phase 3 trial (NCT02477826), evaluating first-line nivolumab, nivolumab plus ipilimumab, or nivolumab plus chemotherapy versus chemotherapy in patients with advanced NSCLC.
    
    Trial design:
    Part 1 of CheckMate 227, which has completed accrual, enrolled adult patients with stage IV/recurrent NSCLC, no prior systemic anticancer therapy, and assessment of PD-L1 expression at screening. Patients with ≥1% PD-L1 expression were randomized 1:1:1 to nivolumab, nivolumab plus ipilimumab, or chemotherapy arms; those with <1% PD-L1 expression were randomized 1:1:1 to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy arms. In part 2, ∼480 previously untreated patients with advanced NSCLC, regardless of PD-L1 expression level, will be randomized 1:1 to receive histology-based platinum doublet chemotherapy alone or in combination with nivolumab. Part 2 of CheckMate 227, which is the focus of this presentation, allows for the evaluation of first-line nivolumab plus chemotherapy in a broad group of patients with advanced NSCLC across the PD-L1–expressing continuum.
    
    Clinical trial identification:
    NCT02477826
    
    Legal entity responsible for the study:
    Bristol-Myers Squibb
    
    Funding:
    Bristol-Myers Squibb
    
    Disclosure:
    L. Paz-Ares: Served as a medical advisor for the following companies: Lilly, Roche, MSD, BMS, Celgene, Pfizer, Boehringer-Ingelheim, Bayer, Clovis, and AstraZeneca. J. Brahmer: Received research grants and served as an uncompensated advisory board member for Bristol-Myers Squibb. M.D. Hellmann: Received grants from Genentech and Bristol-Myers Squibb. Received personal fees from Genentech, Bristol-Myers Squibb, Merck, AstraZeneca, Novartis, and Janssen. M. Reck: Received consultant fees and served on speaker\'s bureau for the following companies: Roche, Lilly, Bristol-Myers Squibb, MSD, AstraZeneca, Pfizer, Boehringer-Ingelheim, and Celgene. K. O\'Byrne: Received honoraria, speaker bureau and/or travel and registration support for national and international meetings from BMS, Boehringer-Ingelheim, Astrazeneca, Lilly Oncology, Novartis, MSD, Roche-Genentech and Pfizer. H. Borghaei: The institution has a clinical trial agreement w/BMS. Consultant/advisory board member for: BMS, Lilly, Genentech, Celgene, EMD-Serono, Merck, Pfizer, Trovagene, Millenium, & Boehringer-Ingelheim. Received grants from: Millenium, Merck, & Celgene. W.J. Geese, H. Lu: BMS Employee and stock holder. F.E. Nathan: BMS employee. S. Ramalingam: Served on ad hoc scientific advisory board meetings the following companies: Astra Zeneca, BMS, Boehringer Ingelheim, Celgene, Ariad, Amgen, Lilly, Merck, Genentech. Also received honoraria from BMS.