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    Association details:
    Biomarker:ROS1 positive
    Cancer:Solid Tumor
    Drug:Augtyro (repotrectinib) (ALK inhibitor, Multi-tyrosine kinase inhibitor, ROS1 inhibitor, Trk inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Non Small Cell Lung Cancer)
    New
    Title:

    Zai Lab Announces Approval of AUGTYRO™ (repotrectinib) for Patients with ROS1-positive NSCLC by China’s NMPA

    Excerpt:
    ...China has approved the New Drug Application (NDA) for AUGTYRO™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2018
    Title:

    A phase 1 study of the next-generation ALK/ROS1/TRK inhibitor ropotrectinib (TPX-0005) in patients with advanced ALK/ROS1/NTRK+ cancers (TRIDENT-1).

    Published date:
    05/16/2018
    Excerpt:
    Phase I eligible pts had ALK, ROS1, or NTRK1-3 fusion-positive advanced solid tumors...Confirmed partial responses (cPR, RECISTv1.1, n = 8) were observed in TKI-naïve or TKI pre-treated ROS1+/NTRK+ pts at all dose levels....Of the 16 ALK+ pts completed 2 cycles of ropo, 4 had confirmed SD (4 cycles) as best response at data cutoff...Ropotrectinib was well-tolerated and exhibited both intra- and extra-cranial clinical activity in TKI-refractory ROS1+ and NTRK+ pts with SFM-containing tumors.
    DOI:
    10.1200/JCO.2018.36.15_suppl.2513
    Trial ID:
    TRIDENT-1