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Huong Trinh

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-83 - Comparative Efficacy Analysis Between Entrectinib Trial and Crizotinib Real-World ROS1 Fusion-Positive (ROS1+) NSCLC Patients (ID 2215)

      09:45 - 18:00  |  Author(s): Huong Trinh

      • Abstract


      Entrectinib is an oral tyrosine kinase inhibitor for ROS1 fusion-positive (ROS1+) NSCLC. Three phase 1/2 single-arm studies showed entrectinib efficacy in this population (Doebele WCLC 2018). Due to the rarity of ROS1+ patients generating direct comparative evidence in prospective randomized trials is difficult. We identified a retrospective real-world cohort of ROS1+ NSCLC patients from electronic health records (EHR), to compare crizotinib, the current standard of care, to entrectinib as reported in clinical trials


      Crizotinib-treated patients with advanced ROS1+ NSCLC diagnosed 1 Jan 2011 to 30 Jun 2018, were identified with technology-enabled abstraction in the Flatiron Health EHR-derived database (>2.1 million cancer patients from US oncology practice). Entrectinib trial inclusion/exclusion criteria were applied to match the crizotinib cohort as closely as possible. Primary endpoint: time to treatment discontinuation (TTD), adapted from Gong (ASCO 2018); real-world progression-free survival (rwPFS; physician/scan report) and overall survival (OS) were secondary outcomes. Time-to-event analyses used Kaplan-Meier survival curves and Cox proportional hazard models on propensity score weighted populations; age, gender, race/ethnicity, smoking status, brain metastasis and previous lines of therapy were prognostic factors.


      We analyzed 53 entrectinib and 69 crizotinib ROS1+ NSCLC patients. Median weighted TTD: entrectinib, 14.6 months (95% CI: 8.3–23.8); crizotinib, 8.8 months (95% CI: 8.2–9.9). When rwPFS from crizotinib was compared to trial PFS, entrectinib had longer PFS vs crizotinib (weighted HR: 0.44; 95% CI: 0.27–0.74). Median OS with entrectinib was not reached (median follow-up: 15.5 months); weighted median OS with crizotinib was 18.5 months (95% CI: 15.1–19.9). Findings were consistent across multiple sensitivity analyses.


      Entrectinib was associated with longer TTD and PFS in ROS1+ NSCLC patients vs a matched real-world crizotinib population. Control populations derived from real-world cohorts can supplement evidence from clinical trials in settings where new standards of care are needed, but where only limited data are available and randomization is not feasible.

      Funding: This study was funded by F. Hoffmann-La Roche