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    Home > Medical News > Latest Medical News > Baoyuan Pharmaceutical and Cinda Bio-Announce Phase 2 Clinical Data of ROS1/NTRK Inhibitors

    Baoyuan Pharmaceutical and Cinda Bio-Announce Phase 2 Clinical Data of ROS1/NTRK Inhibitors

    • Last Update: 2021-10-11
    • Source: Internet
    • Author: User
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    Text|Pharmaceutical Mission Hills

    The 2021 Chinese Society of Clinical Oncology (CSCO) Annual Meeting is underway
    .
    At this conference, Baoyuan Pharmaceutical and Innovent announced the interim data of a new generation of ROS1/NTRK inhibitor taletrectinib for the phase 2 trial of ROS1-positive non-small cell lung cancer (NSCLC) in the form of the conference theme report

    .
    Studies have shown that taletrectinib is promising as a new type of therapy for ROS1-fusion-positive lung cancer

    .

    Taletrectinib is a new generation of tyrosine kinase inhibitor (TKI) under development.
    It targets ROS1 and NTRK fusion mutations and has the potential to treat patients who have not been treated with TKI and who have undergone TKI treatment

    .
    ROS1 fusion mutation is the oncogenic driving factor in about 2%-3% of patients with advanced NSCLC, and NTRK fusion mutation is the oncogenic driving factor in about 0.
    5% of patients with other advanced solid tumors

    .

    Taletrectinib was originally developed by Daiichi Sankyo, and Baoyuan Medicine obtained the exclusive global rights of the drug in 2018
    .
    In July 2020, Baoyuan Pharmaceutical authorized the clinical development and commercialization rights of the candidate drug in South Korea to NewG Lab Pharma

    .
    In June 2021, Cinda Biotech and Baoyuan Pharmaceutical reached a cooperation on the joint development and commercialization of taletrectinib in Greater China

    .

    In this CSCO, Baoyuan Pharmaceutical and Xinda Bio announced the preliminary results of a phase 2 study (TRUST study) of taletrectinib in the treatment of ROS1-positive non-small cell lung cancer
    .
    As of June 16, 2021, a total of 21 patients who have not been treated with crizotinib and 16 patients who have received crizotinib have been confirmed to be ROS1 positive

    .
    The main results of the study are as follows:

    Among 21 patients who had not received crizotinib treatment, the confirmed objective response rate (ORR) was 90.
    5% (19/21), and the disease control rate (DCR) was 90.
    5% (19/21)

    .

    Among the 16 patients who had received crizotinib, the confirmed ORR was 43.
    8% (7/16) and the DCR was 75.
    0% (12/16)

    .

    Among the 16 patients who had received crizotinib treatment, 3 patients were confirmed to be positive for the ROS1 G2032R resistance mutation.
    All 3 patients showed tumor shrinkage.
    Two patients achieved partial remission (PR), and one patient The patient is in stable disease (SD)

    .

    Among patients with evaluable brain metastases before enrollment, the objective response rate in the brain assessed by the investigator was 83.
    3% (5/6)

    .

    Taletrectinib is well tolerated, and treatment-related adverse events mainly include gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevations
    .

    Reference materials:

    [1] Cinda Biosciences and Baoyuan Pharmaceutical announced the interim data of the phase II trial of Taletrectinib in ROS1-positive non-small cell lung cancer at the CSCO annual meeting in 2021.
    Retrieved Sep 27, 2021, from https:// /334186-1.
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