Author of

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  P2.06 - Poster Session with Presenters Present (ID 467)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17854

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    P2.06-012 - Phase 2 Study of Abemaciclib + Pembrolizumab in KRAS Mutation, PD-L1+, Stage IV Non-Small Cell or Squamous Cell Lung Cancer (ID 3762)

    14:30 - 14:30  |  Author(s): W. John
    • Abstract
    • Slides

    Background:
    Stage IV non-small cell lung cancer (NSCLC) harboring KRAS mutations remains a treatment challenge. Abemaciclib, a small molecular inhibitor of both cyclin-dependent kinase (CDK) 4 and CDK6, demonstrated acceptable safety, tolerability, and single-agent activity for patients with different tumors, including NSCLC. Preclinical evidence suggests a lethal interaction between CDK4 inhibition in lung cells and KRAS oncogenes. Pembrolizumab, a humanized monoclonal antibody against PD-1 protein, is approved in the US for patients with metastatic PD-L1+ NSCLC. Both compounds demonstrated manageable toxicities. We thus aim to study the combination of abemaciclib and pembrolizumab in pretreated patients with NSCLC.
    
    Methods:
    This open-label phase 2 study will evaluate safety and preliminary efficacy of abemaciclib 150 mg given orally every 12 hours on a continuous schedule on days 1-21 in combination with intravenous pembrolizumab 200 mg on day 1 of a 21-day cycle to patients in 1 of 3 disease cohorts: KRAS mutation, PD-L1+, stage IV NSCLC (Part A); stage IV NSCLC with squamous histology (Part B); or hormone receptor+, HER2- metastatic breast cancer (Part C). Total target accrual is approximately 75 patients (25 per cohort). Only the 2 NSCLC cohorts will be presented here. Patients eligible for Part A have a confirmed KRAS mutation, PD-L1+ expression score of ≥1%, and are chemotherapy-naïve for metastatic NSCLC. Part B includes patients with predominately squamous NSCLC who have received 1 prior platinum-based chemotherapy for advanced NSCLC. Patients must provide tumor tissue before and after treatment (cycle 3, day 1); have measurable disease, adequate organ function, an ECOG PS ≤1, and a life expectancy ≥12 weeks; and be ≥18 years of age and able to swallow oral medications. The primary objective is to characterize the safety profile of abemaciclib plus pembrolizumab. Secondary objectives include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), characterization of pharmacokinetics, and health outcomes. Patients who receive any study drug will be included in the analyses. Analyses of ORR, DCR, DoR, and PFS will be evaluated according to RECIST v.1.1 and irRECIST. Time-to-event variables will be estimated by Kaplan-Meier methodology. An interim analysis of safety and preliminary efficacy may occur after all patients have completed (or discontinued from) approximately 24 weeks of treatment. The final OS analysis will occur based on data collected for approximately 12 months after the last patient receives treatment.
    
    Results:
    Section not applicable
    
    Conclusion:
    Section not applicable
    
    

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