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    DRUG:

    envonalkib (TQ-B3139)

    i
    Other names: TQ-B3139, TQ B3139, CT-1139, CT-711
    Company:
    Shouyao Holdings, Sino Biopharm
    Drug class:
    ALK inhibitor, ROS1 inhibitor, c-MET inhibitor
    Related drugs:
    1m
    Pharmacokinetics, mass balance, and metabolism of [14C]envonalkib (TQ-B3139), a novel ALK tyrosine kinase inhibitor, in healthy Chinese subjects. (PubMed, Cancer Chemother Pharmacol)
    Envonalkib was extensively metabolized prior to excretion and eliminated primarily as metabolites via feces.
    PK/PD data • Journal
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive
    |
    envonalkib (TQ-B3139)
    9ms
    Envonalkib versus crizotinib for treatment-naive ALK-positive non-small cell lung cancer: a randomized, multicenter, open-label, phase III trial. (PubMed, Signal Transduct Target Ther)
    Grade ≥3 treatment-related adverse events were observed in 55.73% and 42.86% of participants in the envonalkib and crizotinib groups, respectively. Envonalkib significantly improved PFS and delayed brain metastasis progression in advanced ALK-positive NSCLC.
    P3 data • Clinical Trial,Phase III • Journal
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK rearrangement
    |
    Xalkori (crizotinib) • envonalkib (TQ-B3139)
    over1year
    Envonalkib vs crizotinib in treatment-naïve advanced ALK-positive NSCLC: A randomized, multicenter, phase III trial (ESMO Asia 2022)
    Conclusions Compared with Cri, Env significantly prolonged PFS in advanced ALK-positive NSCLC pts who had not received a prior ALK inhibitor, and showed greater advantages in controlling BMs. The safety profiles following Env treatment were manageable.
    Clinical • P3 data
    |
    ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    TP53 mutation • ALK positive
    |
    Xalkori (crizotinib) • envonalkib (TQ-B3139)
    over1year
    First-in-human phase I study of TQ-B3139 (CT-711) in advanced non-small cell lung cancer patients with ALK and ROS1 rearrangements. (PubMed, Eur J Cancer)
    TQ-B3139 was well-tolerated and exhibited promising anti-tumor activities in patients with ALK and ROS1 positive advanced NSCLC.
    P1 data • Clinical Trial,Phase I • Journal
    |
    ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK positive • ALK rearrangement • ALK mutation • ROS1 fusion • ROS1 positive • ROS1 rearrangement • ALK positive + ROS1 positive
    |
    envonalkib (TQ-B3139)
    3years
    Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules (clinicaltrials.gov)
    P1, N=12, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: Mar 2021 --> Mar 2022
    Clinical • Enrollment open • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    MET amplification • ALK fusion • ALK mutation • ROS1 fusion • MET mutation • ALK-ROS1 fusion
    |
    envonalkib (TQ-B3139)
    over3years
    Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    Clinical • New P1 trial
    |
    ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    MET amplification • ALK fusion • ALK mutation • ROS1 fusion • MET mutation • ALK-ROS1 fusion
    |
    envonalkib (TQ-B3139)