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D.R. Spigel



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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
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      143TiP - IMpower110: Phase III trial of 1L atezolizumab in PD-L1–selected chemotherapy-naive NSCLC (ID 364)

      12:30 - 13:00  |  Author(s): D.R. Spigel

      • Abstract

      Background:
      Despite poor survival and toxicities, chemotherapy is the standard of care and remains the main first-line option for patients (pts) with advanced NSCLC non-squamous (non-sq) and squamous (sq) histology without genetic driver alterations. Immunotherapies targeting PD-L1/PD-1 are available for 2L+ NSCLC but remain to be fully studied in the 1L setting. Atezolizumab (atezo), an anti–PD-L1 mAb, prevents PD-L1 interacting with PD-1 and B7.1, restoring tumor-specific T-cell immunity. Significant and clinically relevant survival benefit has been shown with atezo in previously treated NSCLC, regardless of PD-L1 expression on tumor cells (TC) and/or tumor-infiltrating immune cells (IC). IMpower110 (NCT02409342), a global Phase III randomized, multicenter, open-label trial, will evaluate efficacy and safety of 1L atezo vs cisplatin (cis)/carboplatin (carbo) + pemetrexed (pem) or gemcitabine (gem) in PD-L1–selected chemotherapy-naive pts with advanced non-sq or sq NSCLC, respectively.

      Trial design:
      Inclusion criteria include stage IV non-sq or sq NSCLC, measurable disease (RECIST v1.1), ECOG PS 0-1, no prior chemotherapy for advanced NSCLC and centrally assessed PD-L1 expression of ≥ 1% on TC or IC (TC1/2/3 or IC1/2/3 with VENTANA SP142 IHC assay; expected prevalence, ≈ 65%). Exclusion criteria include active or untreated CNS metastases, prior immune checkpoint blockade therapy or autoimmune disease. Pts will be randomized 1:1 to receive atezo or cis/carbo + pem (non-sq)/gem (sq) (4 or 6 21-day cycles are allowed). Pts receiving atezo may continue until loss of clinical benefit, while pts in the comparator arm can receive pem maintenance (non-sq) or best supportive care (sq) until disease progression. Stratification factors are sex, ECOG PS, histology (non-sq vs sq) and centrally assessed PD-L1 expression by IHC. Co-primary endpoints are PFS and OS. Key secondary endpoints are ORR, DOR, IRF-assessed PFS (RECIST v1.1) and TTD in pt-reported lung cancer symptoms. Safety and PK will also be evaluated. Tumor biopsies at progression will be assessed for immunologic biomarkers associated with responses to atezo and to differentiate unusual responses from radiographic progression. Approximately 570 pts will be enrolled.

      Clinical trial identification:
      NCT02409342

      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:
      J. Jassem: Speaker: AstraZeneca, Roche, Pfizer; Advisory roles: AstraZeneca, Boehringer, BMS, Celgene, G1 Therapeutics, Merck, Pfizer, Pierre Fabre, Roche; Travel support: Roche, Boehringer. F. de Marinis: Consultation fees received from Roche/BMS/Boehringer/Novartis/Pfizer/MSD/Astrazeneca. D.R. Spigel: Consulting/Advisory Role: Genentech (uncompensated); Travel, accommodation, expenses: Genentech. S. Lam, S. Mocci, A. Sandler, A. Lopez-Chavez, Y. Deng: Employee, stock: Roche/Genentech. G. Giaccone: Consulting or Advisory Role: Clovis, Boehringer-Ingelheim; Celgene; Research grants: Karyopharm, Astra-Zeneca; Eli-Lilly. R.S. Herbst: Consultant and research support from Genentech