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Association details:
| Biomarker: | ROS1 fusion |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Augtyro (repotrectinib) (ALK inhibitor, Multi-tyrosine kinase inhibitor, ROS1 inhibitor, Trk inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
Excerpt:
...Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion....
Trial ID:
Source:
Title:
596P - Repotrectinib in patients (pts) from Asia and China with ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC): Results from the phase I/II TRIDENT-1 trial
Published date:
11/27/2023
Excerpt:
Pts with ROS1+ NSCLC were enrolled in distinct cohorts based on prior treatment. Recommended phase 2 dose was 160 mg once daily for 14 d, then 160 mg twice daily….In TRIDENT-1, repotrectinib showed durable clinical activity, intracranial response, and manageable safety in both TKI-naïve and -pretreated pts from Asia, including pts from China.
Trial ID:
Source:
Title:
Intracranial and systemic efficacy of repotrectinib in advanced ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC) and central nervous system metastases (CNS mets) in the phase 1/2 TRIDENT-1.
Published date:
05/25/2023
Excerpt:
At data cutoff (June 20, 2022), 0 of 7 responders in the TKI-naïve cohort and 2 of 5 in the cohort with 1 prior TKI and no chemo had intracranial progression or death; intracranial DOR range was 1.9-14.8+ mo (TKI-naïve) and 3.0-11.1+ mo (1 TKI and no chemo), with 86% and 80% of pts with an intracranial response remaining on treatment, respectively....In TRIDENT-1, repotrectinib showed durable clinical activity in ROS1 TKI-naïve and -pretreated pts with or without BL CNS mets, including intracranial responses. Repotrectinib safety profile was similar in pts with ROS1+ NSCLC with or without CNS mets.
DOI:
10.1200/JCO.2023.41.16_suppl.9017
Trial ID:
Source:
Title:
Pivotal topline data from the phase 1/2 TRIDENT-1 trial of repotrectinib in patients with ROS1+ advanced non-small cell lung cancer (NSCLC)
Published date:
10/28/2022
Excerpt:
We report updated results in TKI-naïve and -pretreated patients with advanced, ROS1 fusion-positive (ROS1+) NSCLCs....Repotrectinib achieves durable activity, including intracranial responses, in TKI-naïve and TKI-pretreated patients with ROS1+ advanced NSCLC...
DOI:
https://doi.org/10.1016/S0959-8049(22)00812-7
Trial ID:
Source:
Title:
MA11.07 - Phase 1/2 TRIDENT-1 Study of Repotrectinib in Patients with ROS1+ or NTRK+ Advanced Solid Tumors
Published date:
01/12/2021
Excerpt:
Repotrectinib was well tolerated and continues to demonstrate encouraging overall clinical activity in pts with ROS1 fusion-positive NSCLC and TRK fusion-positive solid tumors.
Trial ID:
