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    Updated integrated analysis of the efficacy and safety of entrectinib in locally advanced or metastatic ROS1 fusion-positive non-small-cell lung cancer

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    Authors
    Dziadziuszko, R.
    Krebs, Matthew G
    De Braud, F.
    Siena, S.
    Drilon, A.
    Doebele, R. C.
    Patel, M. R.
    Cho, B. C.
    Liu, S. V.
    Ahn, M. J.
    Chiu, C. H.
    Farago, A. F.
    Lin, C. C.
    Karapetis, C. S.
    Li, Y. C.
    Day, B. M.
    Chen, D.
    Wilson, T. R.
    Barlesi, F.
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    Affiliation
    Medical University of Gdańsk, Gdańsk, Poland
    Issue Date
    2021
    
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    Abstract
    Purpose: Genetic rearrangements of the tyrosine receptor kinase ROS proto-oncogene 1 (ROS1) are oncogenic drivers in non-small-cell lung cancer (NSCLC). We report the results of an updated integrated analysis of three phase I or II clinical trials (ALKA-372-001, STARTRK-1, and STARTRK-2) of the ROS1 tyrosine kinase inhibitor, entrectinib, in ROS1 fusion-positive NSCLC. Methods: The efficacy-evaluable population included adults with locally advanced or metastatic ROS1 fusion-positive NSCLC with or without CNS metastases who received entrectinib ≥ 600 mg orally once per day. Co-primary end points were objective response rate (ORR) assessed by blinded independent central review and duration of response (DoR). Secondary end points included progression-free survival (PFS), overall survival (OS), intracranial ORR, intracranial DoR, intracranial PFS, and safety. Results: In total, 161 patients with a follow-up of ≥ 6 months were evaluable. The median treatment duration was 10.7 months (IQR, 6.4-17.7). The ORR was 67.1% (n = 108, 95% CI, 59.3 to 74.3), and responses were durable (12-month DoR rate, 63%, median DoR 15.7 months). The 12-month PFS rate was 55% (median PFS 15.7 months), and the 12-month OS rate was 81% (median OS not estimable). In 24 patients with measurable baseline CNS metastases by blinded independent central review, the intracranial ORR was 79.2% (n = 19; 95% CI, 57.9 to 92.9), the median intracranial PFS was 12.0 months (95% CI, 6.2 to 19.3), and the median intracranial DoR was 12.9 months (12-month rate, 55%). The safety profile in this updated analysis was similar to that reported in the primary analysis, and no new safety signals were found. Conclusion: Entrectinib continued to demonstrate a high level of clinical benefit for patients with ROS1 fusion-positive NSCLC, including patients with CNS metastases.
    Citation
    Dziadziuszko R, Krebs MG, De Braud F, Siena S, Drilon A, Doebele RC, et al. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2021:JCO2003025.
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/623874
    DOI
    10.1200/jco.20.03025
    PubMed ID
    33646820
    Additional Links
    https://dx.doi.org/10.1200/jco.20.03025
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1200/jco.20.03025
    Scopus Count
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