Author of

• 18975

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  P3.01 - Advanced NSCLC (ID 621)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 24640

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    P3.01-088i - Phase Ib Trial of Xentuzumab and Abemaciclib in Advanced or Metastatic Solid Tumors, including Advanced NSCLC (ID 8572)

    09:30 - 09:30  |  Author(s): T. Bogenrieder
    • Abstract
    • Slides

    Background:
    There remains an unmet need for additional treatment options in patients with advanced non-small cell lung cancer (NSCLC) refractory to chemotherapy and immunotherapy. The insulin-like growth factor (IGF) axis and cyclin D-cyclin-dependent kinase (CDK) 4/6-retinoblastoma pathway have been implicated in the pathogenesis and resistance mechanisms of a variety of cancers, including NSCLC. Binding of IGF-I and -II to the IGF receptor results in upregulation of cyclin D1, and subsequent progression through the cell cycle, thus providing rationale for the simultaneous inhibition of IGF-I and -II and CDK4/6. This trial assesses the maximum-tolerated dose (MTD)/recommended phase II dose (RP2D), safety and preliminary efficacy of the IGF-ligand-neutralizing antibody, xentuzumab, in combination with abemaciclib, a selective, small-molecule inhibitor of both CDK4 and 6, in patients with solid tumors. One of two expansion cohorts (Cohort E) will further characterize the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of the combination in patients with NSCLC.
    
    Method:
    Study BI 1280.18 (NCT03099174) is a phase Ib multicenter, non-randomized, open-label, dose escalation trial with four dose-finding cohorts (Cohorts A–D) followed by two expansion cohorts (Cohorts E, F). For the NSCLC cohort (Cohort E), eligible patients include adults ≥18 years (≥20 for Japan), with measurable or evaluable disease, adequate organ function, ECOG PS≤1, and CDK4/6 inhibitor-naïve stage IV NSCLC after 1–2 lines of therapy and failure after platinum-based chemotherapy and immunotherapy. Patients with NSCLC (Cohort E) will receive the combination at the RP2D determined in patients with solid tumors (Cohort A) who will receive xentuzumab (starting dose 1,000 mg weekly i.v.) plus abemaciclib (starting dose 150 mg every 12 hours). The primary endpoint of Cohort E is the objective response (OR) in patients with pre-treated advanced NSCLC; disease control, duration of disease control, time to OR, duration of OR, and progression-free survival (PFS) are secondary endpoints. This study will be conducted in the US, Europe and Japan. Patient screening started in May 2017. Target enrolment is ~88 patients, including ~20 patients with stage IV NSCLC refractory to platinum-based chemotherapy and immunotherapy.
    
    Result:
    Section not applicable
    
    Conclusion:
    Section not applicable
    
    

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