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Molecular Profile | ROS1 fusion |
Therapy | Repotrectinib |
Indication/Tumor Type | lung non-small cell carcinoma |
Response Type | sensitive |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
ROS1 fusion | lung non-small cell carcinoma | sensitive | Repotrectinib | FDA approved | Actionable | In a Phase I/II trial (TRIDENT-1) that supported FDA approval, Augtyro (repotrectinib) resulted in an objective response rate of 79% (56/71, 7 complete and 49 partial responses) and 38% (21/56, 3 complete and 18 partial responses), median duration of response of 34.1 and 14.8 months, and a median progression-free survival of 35.7 and 9.0 months in patients with TKI-naive and TKI-treated, ROS1 fusion-positive non-small cell lung cancer, respectively (PMID: 38197815; NCT03093116). | 38197815 detail... |
ROS1 fusion | lung non-small cell carcinoma | sensitive | Repotrectinib | Phase Ib/II | Actionable | In a Phase I/II trial (TRIDENT-1), Augtyro (repotrectinib) treatment resulted in an intracranial objective response rate (icORR) of 88% (7/8) with intracranial duration of response (DOR) ranging from 1.9-14.8 months in non-small cell lung cancer patients harboring ROS1 fusions who were TKI-naive, and an icORR of 42% (5/12) with intracranial DOR ranging from 3.0-11.1 months in those with 1 prior TKI and no chemo (J Clin Oncol 41, 2023 (suppl 16; abstr 9017); NCT03093116). | detail... |
PubMed Id | Reference Title | Details |
---|---|---|
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. | Full reference... | |
Augtyro (repotrectinib) FDA Drug Label | Full reference... | |
(38197815) | Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. | Full reference... |