Author of

• 20050

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  Targeted therapies and immunotherapies (ID 46)

  • Event: ELCC 2017
  • Type: Poster Discussion session
  • Track:
  • Presentations: 1
  • Moderators:S. Ekman, N. Reguart
  • Coordinates: 5/07/2017, 14:45 - 15:45, Room W

  • 20051

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    89PD - Results from OAK subgroup analyses: A randomized Phase III study of atezolizumab vs docetaxel in patients (pts) with advanced NSCLC (ID 317)

    14:45 - 14:45  |  Author(s): M. Cobo Dols
    • Abstract

    Background:
    Atezolizumab (atezo) prevents binding of PD-L1 to its receptors PD-1 and B7.1, restoring tumor-specific T-cell immunity. Primary analysis of the Phase III OAK study in previously treated NSCLC showed superior survival with atezo vs docetaxel (doc) in the ITT population (mOS, 13.8 vs 9.6 months; HR, 0.73) and in pts expressing ≥1% PD-L1 on TC or IC (TC1/2/3 or IC1/2/3; mOS, 15.7 vs 10.3; HR, 0.74). Here we present further subgroup analyses.
    
    Methods:
    OAK evaluated atezo vs doc in PD-L1 unselected NSCLC pts who had failed prior platinum-containing chemotherapy. Pts were stratified by PD-L1 expression, prior chemotherapy regimens and histology and randomized 1:1 to atezo (1200 mg) or doc (75 mg/m[2]) IV q3w. PD-L1 expression by IHC and mRNA was centrally evaluated by VENTANA SP142 IHC assay and Fluidigm, respectively. Data cutoff, July 7, 2016.
    
    Results:
    In the first 850 of 1225 randomized pts (primary study population), OS was improved with atezo vs doc regardless of histology, and this benefit was seen across PD-L1 subgroups within each histology (Table). Similar OS was seen regardless of PD-L1 expression as assessed by mRNA and IHC. ORR was 14.4% vs 15.2% in non-squamous (non-sq) pts and 11.6% vs 8.2% (atezo vs doc) in squamous (sq) pts. Improved OS was seen with atezo vs doc across subgroups, including pts with treated baseline brain metastases (n = 85; mOS, 20.1 vs 11.9 mo; HR, 0.54; 95% CI, 0.63, 0.89) and never smokers (n = 156; mOS, 16.3 vs 12.6 mo; HR, 0.71; 95% CI, 0.47, 1.08). Further secondary endpoints and exploratory biomarker analyses for these subgroups and by age and EGFR/KRAS status will be presented.
    
    Conclusions:
    OAK demonstrated clinically relevant improvements with atezo in the ITT population, including in both histology subgroups, regardless of PD-L1 expression (measured by IHC or tumor gene expression), and among other subgroups, including never smokers and pts with baseline brain metastases.rnTable: 89PDrn

    rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn rnrn

    rn	OS
    	Atezo		Doc		HR[a] 95% CI
    	n	Median, mo	n	Median, mo
    Non-sq population
    TC3 or IC3	49	22.5	47	8.7	0.35 (0.21, 0.61)
    TC2/3 or IC2/3	89	18.7	99	11.3	0.61 (0.42, 0.88)
    TC1/2/3 or IC1/2/3	171	17.6	162	11.3	0.72 (0.55, 0.95)
    TC0 and IC0	140	14.0	150	11.2	0.75 (0.57, 1.00)
    All non-sq	313	15.6	315	11.2	0.73 (0.60, 0.89)
    Sq population
    TC3 or IC3	23	17.5	18	11.6	0.57 (0.27, 1.20)
    TC2/3 or IC2/3	40	10.4	37	9.7	0.76 (0.45, 1.29)
    TC1/2/3 or IC1/2/3	70	9.9	60	8.7	0.71 (0.48, 1.06)
    TC0 and IC0	40	7.6	49	7.1	0.82 (0.51, 1.32)
    All sq	112	8.9	110	7.7	0.73 (0.54, 0.98)

    rnaUnstratified HRs.rnTC, tumor cell; IC, tumor-infiltrating immune cell.rn
    
    Clinical trial identification:
    NCT02008227
    
    Legal entity responsible for the study:
    F. Hoffmann-La Roche Ltd/Genentech Inc., a member of the Roche Group
    
    Funding:
    F. Hoffmann-La Roche Ltd/Genentech Inc., a member of the Roche Group
    
    Disclosure:
    S.M. Gadgeel: Speaker\'s bureau from Astra-Zeneca, Genentech/Roche and Advisory Boards from Astra-Zeneca, Ariad, Pfizer, Bristol Myers- Squibb and Genentech/Roche. A. Rittmeyer: Grants as an advisor or speaker by Astra Zeneca, BMS, Boehringer Ingelheim, Eli Lilly, Pfizer and Roche Genentech. F. Barlesi: Honarium from Roche. T. Hida: Corporate-sponsored research from Chugai Pharmaceutical. P. He: Employee of Roche/Genentech, and has stocks for Roche and Amgen. Her husband has stocks for Allergan and Gilead. M. Ballinger: Genentech/Roche employee and has Roche stock. D.R. Gandara: Consultant for Genentech and clinical trial grant from Genentech. J. von Pawel: Adboard with fees paid to the institution from AbbVie, Pfizer, Bristol Myers Squibb, and Novartis. All other authors have declared no conflicts of interest.