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J. Wilken Hay



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    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.01-19 - Phase 2 Study of Telisotuzumab Vedotin (Teliso-V) in Previously Treated c-MET+ Non-Small Cell Lung Cancer: Trial in Progress (ID 1986)

      10:15 - 18:15  |  Author(s): J. Wilken Hay

      • Abstract
      • Slides

      Background

      Telisotuzumab vedotin (ABBV-399; teliso-v), an anti–c-Met antibody-drug conjugate, demonstrated favorable antitumor activity in a phase 1/1b trial (NCT02099058) in patients with non-small cell lung cancer (NSCLC) and c-MET protein overexpression (c-MET+). Evidence from this study supported additional analysis of teliso-v in patients with c-MET+ NSCLC. Herein, we describe the first phase 2 study of teliso-v. The aim of this study is to evaluate the potential activity and safety profile of teliso-v as a later line of therapy in a biomarker-selected population(s) of patients with NSCLC.

      Method

      This is a 2-stage (Figure) multicenter, non-randomized, single-arm phase 2 study (NCT03539536) in patients (≥18 years; Eastern Cooperative Oncology Group performance status 0–1) with c-MET+ locally advanced or metastatic histologically confirmed NSCLC. Stage 1 is designed to identify the target c-MET+ NSCLC population(s) best suited for teliso-v therapy in the second- or third-line setting using a novel multifactor Bayesian hierarchical model. In Stage 2, the group(s) that demonstrate promising results during Stage 1 will be expanded in a single-arm cohort to further evaluate teliso-v efficacy in the selected population(s). Teliso-v will be administered intravenously at a dosage of 1.9 mg/kg every 2 weeks until disease progression/intolerable toxicity. The primary endpoint is overall response rate according to Response Evaluation Criteria In Solid Tumors version 1.1. Secondary endpoints include duration of response, disease control rate, duration of disease control, progression-free survival, overall survival, safety, and tolerability. Pharmacokinetic samples will be collected pre-treatment and at specific timepoints during the study. Tumor samples will be collected pre-treatment for biomarker analysis. The trial is active, with the first patient screened on 11/05/2018. As of 3/11/2019, 13 centers in 5 countries have enrolled 3 patients.

      trials in progress figure.png

      Result

      Section not applicable

      Conclusion

      Section not applicable

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