Author of

• 19946

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  Immunotherapies and targeted therapies in advanced NSCLC (ID 39)

  • Event: ELCC 2017
  • Type: Proffered Paper session
  • Track:
  • Presentations: 1
  • Moderators:L. Paz-Ares, N. Reguart
  • Coordinates: 5/06/2017, 14:45 - 16:15, Room B

  • 19948

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    84O - Atezolizumab as first-line (1L) therapy for advanced non-small cell lung cancer (NSCLC) in PD-L1–selected patients: Efficacy data from the BIRCH trial (ID 367)

    15:00 - 15:15  |  Author(s): T. Kurata
    • Abstract
    • Slides

    Background:
    Atezolizumab (atezo) inhibits binding of PD-L1 to its receptors, PD-1 and B7.1, restoring tumor-specific T-cell immunity and leaving the PD-L2/PD-1 interaction intact. This single-arm Phase II study (BIRCH; NCT02031458) was designed to evaluate atezo monotherapy in PD-L1–selected patients with advanced NSCLC. A previous analysis (median follow-up, 8.5 months) demonstrated clinical activity in chemotherapy-naive 1L and 2L+ PD-L1–selected patients. Here we present updated efficacy data for 1L patients.
    
    Methods:
    Eligible patients had PD-L1–selected advanced-stage NSCLC, with no prior chemotherapy or CNS metastases. PD-L1 was centrally evaluated using the VENTANA SP142 IHC assay. Enrolled patients expressed PD-L1 on ≥ 5% of tumor cells (TC) or tumor-infiltrating immune cells (IC), ie, TC2/3 or IC2/3. Those with EGFR mutation or ALK rearrangement must have had prior treatment with an appropriate TKI. Atezo was administered (1200 mg IV q3w) until radiographic disease progression or unacceptable toxicity. The primary endpoint was independent review facility (IRF)–assessed ORR; secondary endpoints included investigator (INV)-assessed ORR, DOR, PFS (RECIST v1.1) and OS.
    
    Results:
    With a median duration of survival follow-up of 22.5 months, INV-assessed ORR was 25% in TC2/3 or IC2/3 (all treated) patients and 34% in TC3 or IC3 patients (Table). Median OS was 23.5 months in all treated patients and 26.9 months in the TC3 or IC3 subgroup. Responses were observed in both EGFR and KRAS mutant and wild-type tumors. The safety profile was consistent with previous atezo NSCLC studies.
    
    Conclusions:
    With a median follow-up of 22.5 months, atezo continued to demonstrate durable clinical benefit in 1L NSCLC, in both EGFR and KRAS mutant and wild-type tumors. These results support ongoing Phase III trials evaluating atezo vs chemotherapy in 1L NSCLC.rnTable: 84Orn

    rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn

    Endpoint (95% CI)	TC3 or IC3[a] (n = 65)	TC2/3 or IC2/3[b] (n = 138)
    INV ORR, %	34%	25%
    	(22.6-46.7)	(18.4-33.5)
    EGFR mutant/wild type, ORR, %	25%/31%	31%/22%
    KRAS mutant/wild type, ORR, %	38%/30%	31%/22%
    Median DOR, mo	NE	16.5
    	(8.5-NE)	(9.9-NE)
    Median OS, mo	26.9	23.5
    	(12.0-NE)	(18.1-NE)
    12-mo OS rate, %	61.5%	66.4%
    	(49.0-74.0)	(58.1-74.6)
    Median PFS, mo	7.3	7.3
    	(4.9-12.0)	(5.7-9.7)
    12-mo PFS rate, %	36.5%	32.5%
    	(24.0-48.9)	(24.2-40.8)

    rnNE, not estimable.rnaTC ≥ 50% or IC ≥ 10% PD-L1–expressing cells.rnbTC or IC ≥ 5% PD-L1–expressing cells.rn
    
    Clinical trial identification:
    NCT02031458
    
    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:
    M.C. Garassino: Honoraria, Consulting, Speaker\'s Bureau, research funding, expert testimony, travel expenses: MSD, BMS, AZ, Lilly, Roche. D. Christoph: Honoraria, Speaker\'s Bureau: BI, BMS, Chugai, Novartis, Merck, MSD, Pfizer, Roche; Consulting: BI, BMS, Novartis, Pfizer, Roche; Expert testimony: BI, BMS, Novartis, Pfizer, Roche. J. Chaft: Advisor for Genentech and Astra Zeneca. M.L. Johnson: Consulting: Genentech, Celgene, BI; Research funding: OncoMed, BerGenBio, Lilly, EMD Serono, Kadmon, Janssen, Mirati, Genmab, Pfizer, AZ, Roche/Genentech, Stemcentrix, Novartis, Checkpoint, Array, Regeneron. S. Mocci: Employee, stock: Roche/Genentech. S.N. Gettinger: Consulting: BMS; Research funding: Roche/Genentech, BMS, ARIAD, Incyte, Celldex. E. Felip: Advisory Boards: Lilly, Pfizer, BI, MSD, Roche; Speaker\'s Bureau: AZ, BMS, Novartis. All other authors have declared no conflicts of interest.
    
    

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