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A.S. Mansfield

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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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      58TiP - IMpower133: Phase I/III trial of first-line atezolizumab with carboplatin and etoposide in ES-SCLC (ID 421)

      12:30 - 13:00  |  Author(s): A.S. Mansfield

      • Abstract

      Platinum-based chemotherapy (chemo) with etoposide is the current first-line standard of care for the majority of patients (pts) with ES-SCLC. However, survival outcomes remain poor (median OS, < 1 year) despite initial response rates ranging from 50%-70%. Atezolizumab (atezo) is an anti–PD-L1 mAb that prevents the interaction of PD-L1 with its receptors, PD-1 and B7.1, and restores antitumor T-cell activity. Tolerable safety with promising durability of response has been shown with atezo in pts with ES-SCLC: confirmed ORR was 6% (n = 1/17 [partial response]; DOR of 7 mo) by RECIST v1.1 and 24% by immune-related response criteria (irRC; n = 4/17, with 2 pts on atezo for ≥ 12 mo). Preliminary data also indicate the potential synergy between atezo and platinum-based chemo in NSCLC whereby durable responses may translate into improved survival compared with atezo alone. IMpower133 (NCT02763579), a global, Phase I/III, randomized, multicenter, double-blinded, placebo-controlled trial, will evaluate the efficacy and safety of 1L atezo + carboplatin + etoposide compared with placebo + carboplatin + etoposide in treatment-naive pts with ES-SCLC.

      Trial design:
      Eligibility criteria include ES-SCLC, measurable disease (RECIST v1.1), ECOG PS 0-1 and no prior systemic anticancer treatment. Exclusion criteria include untreated CNS metastases and history of autoimmune disease. Submission of tumor tissue is a study requirement but pts will be enrolled regardless of biomarker status. Stratification factors are sex, ECOG performance status and presence of treated brain metastases. Eligible pts will be randomized 1:1 to receive four 21-day cycles of atezo (1200 mg IV) or placebo in combination with carboplatin (AUC 5 mg/mL/min IV, d 1) and etoposide (100 mg/m[2] IV, d 1-3), followed by maintenance therapy with atezo or placebo until PD per RECIST v1.1. Pts can continue with treatment until persistent radiographic PD, symptomatic deterioration or unacceptable toxicity. Co-primary endpoints are investigator-assessed PFS per RECIST v1.1 and OS. Secondary efficacy endpoints include investigator-assessed ORR and DOR. Safety and tolerability will also be assessed. Approximately 400 pts will be enrolled.

      Clinical trial identification:

      Legal entity responsible for the study:
      F. Hoffmann-La Roche Ltd/Genentech Inc.

      F. Hoffmann-La Roche Ltd/Genentech Inc.

      M. Reck: Honoraria for lectures and consultancy with Boehringer-Ingelheim, Hoffmann-La Roche, Lilly, MSD, BMS, AstraZeneca, Celgene, Merck, Pfizer. A.S. Mansfield: Advisory Board: Genentech, BMS, and Trovagene. S.V. Liu: Advisory board/consultant for: Genentech, Pfizer, Ariad, Celgene, Boehringer Ingelheim, Lilly. T.S.K. Mok: Grant/Speaker/AdBoards: AZ, BI, Pfizer, Novartis, SFJ, Roche, MSD, Clovis, BMS, Eisai, Taiho, Lilly, Merck, ACEA, Vertex, BMS, geneDecode, OncoGenex, Celgene, Ignyta, Taiho; Stock: Sanomics; Board: IASLC, CLCRF, CSCO, HKCTS. X. Tang: Roche employee. S. Lam: Roche/Genentech: employee, stock. F. Kabbinavar, A. Lopez-Chavez, A. Sandler: Employee, stock: Roche/Genentech. L. Horn: Advisory board: Genentech; Consulting: Abbvie, Merck, Lilly, Xcovery and EMD Serono.