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Molecular Profile ROS1 rearrange
Therapy Taletrectinib
Indication/Tumor Type lung non-small cell carcinoma
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 rearrange lung non-small cell carcinoma sensitive Taletrectinib Guideline Actionable Ibtrozi (taletrectinib) is included in guidelines as preferred first-line or subsequent therapy for patients with advanced or metastatic non-small cell lung cancer harboring a ROS1 rearrangement (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Taletrectinib FDA approved - On Companion Diagnostic Actionable In a Phase II trial (TRUST-II) that supported FDA approval, Ibtrozi (taletrectinib) treatment demonstrated safety in non-small cell lung cancer patients with ROS1 rearrangement and resulted in a confirmed investigator-assessed objective response rate (cORRinv) of 94% (17/18) and a disease control rate (DCR) of 100% in the treatment-naive cohort and a cORRinv of 55% (12/22) and DCR of 91% in the previously treated cohort (Ann Oncol (2023) 34 (suppl_2):S788-S789; NCT04919811). detail... detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Taletrectinib FDA approved - On Companion Diagnostic Actionable In a Phase II trial (TRUST-I) that supported FDA approval, Ibtrozi (taletrectinib) therapy resulted in a 90.6% (96/106) overall response rate (ORR) and 95.3% disease control rate (DCR) in TKI-naive non-small cell lung cancer patients with ROS1 rearrangement and 51.5% (34/66) ORR and 83.3% DCR in pretreated patients, intracranial ORR of 87.5% (7/8) and DCR of 100% in patients with baseline brain lesions, and partial responses in 8 of 12 patients with secondary ROS1 G2032R (PMID: 38822758; NCT04395677). detail... 38822758
ROS1 rearrange lung non-small cell carcinoma sensitive Taletrectinib Phase I Actionable In a Phase I trial, Ibtrozi (taletrectinib) demonstrated manageable toxicity, resulted in an objective response rate of 33.3% (2/6) in patients with advanced non-small cell lung cancer harboring ROS1 rearrangements (PMID: 32591465). 32591465
PubMed Id Reference Title Details
NCCN.org Full reference...
(32591465) U.S. Phase I First-in-human Study of Taletrectinib (DS-6051b/AB-106), a ROS1/TRK Inhibitor, in Patients with Advanced Solid Tumors. Full reference...
1373P Efficacy and safety of taletrectinib in patients (Pts) with ROS1+ non-small cell lung cancer (NSCLC): Interim analysis of global TRUST-II study Full reference...
(38822758) Efficacy and Safety of Taletrectinib in Chinese Patients With ROS1+ Non-Small Cell Lung Cancer: The Phase II TRUST-I Study. Full reference...
Ibtrozi (taletrectinib) FDA Drug Label Full reference...
Ibtrozi (taletrectinib) FDA Drug Label Full reference...