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Therapy Name	Taletrectinib
Synonyms
Therapy Description	Ibtrozi (taletrectinib) is an inhibitor of NTRK1/2/3 and ROS1 fusion proteins, which blocks downstream signaling and may lead to inhibition of tumor cell growth (PMID: 32591465). Ibtrozi (taletrectinib) is FDA-approved for use in patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (FDA.gov).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Taletrectinib	Ibtrozi	DS6051b\|DS-6051B\|DS-6051\|AB-106	ROS1 Inhibitor 23 Trk Receptor Inhibitor (Pan) 33	Ibtrozi (taletrectinib) is an inhibitor of NTRK1/2/3 and ROS1 fusion proteins, which blocks downstream signaling and may lead to inhibition of tumor cell growth (PMID: 32591465). Ibtrozi (taletrectinib) is FDA-approved for use in patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (FDA.gov).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
ROS1 fusion	lung non-small cell carcinoma	sensitive	Taletrectinib	FDA approved	Actionable	In a Phase II trial (TRUST-II) that supported FDA approval, Ibtrozi (taletrectinib) treatment demonstrated safety in ROS1 fusion-positive non-small cell lung cancer patients 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 fusion	lung non-small cell carcinoma	sensitive	Taletrectinib	FDA approved	Actionable	In a Phase II trial (TRUST-I) that supported FDA approval, Ibtrozi (taletrectinib) treatment 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 fusions 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 mutations (PMID: 38822758; NCT04395677).	38822758 detail...
ROS1 fusion	lung non-small cell carcinoma	sensitive	Taletrectinib	Phase II	Actionable	In a combined analysis of 2 Phase II trials (TRUST-I, TRUST-II), Ibtrozi (taletrectinib) treatment was safe and resulted in a confirmed objective response rate (cORR) of 88.8%, a median duration of response (mDOR) of 44.2 mo, and a median progression-free survival of 45.6 mo in TKI-naive, ROS1 fusion-positive non-small cell lung cancer patients (n=160), and a cORR of 55.8%, mDOR of 16.6 mo, and mPFS of 9.7 mo in TKI-pretreated patients (n=113) (PMID: 40179330; NCT04919811, NCT04395677).	40179330
ROS1 fusion	lung non-small cell carcinoma	sensitive	Taletrectinib	Phase I	Actionable	In a Phase I trial, Ibtrozi (taletrectinib) was well-tolerated and demonstrated some preliminary efficacy in patients with advanced solid tumors, including a partial response in a patient with non-small cell lung cancer liver metastases harboring a ROS1 fusion (Cancer Res 2016;76(14 Suppl):Abstract nr CT024; NCT02279433).	detail...
ROS1 rearrange	lung non-small cell carcinoma	predicted - 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
ROS1 fusion ROS1 G2032R	lung non-small cell carcinoma	predicted - sensitive	Taletrectinib	Case Reports/Case Series	Actionable	In a Phase II trial (TRUST-I), Ibtrozi (taletrectinib) treatment resulted in an objective response rate of 66.7% (8/12, all partial responses) in patients with non-small cell lung cancer harboring ROS1 fusions with secondary ROS1 G2032R mutations (PMID: 38822758; NCT04395677).	38822758
EML4 - ALK	Advanced Solid Tumor	sensitive	Taletrectinib	Preclinical - Cell culture	Actionable	In a preclinical study, cells expressing EML4-ALK were sensitive to treatment with Ibtrozi (taletrectinib) in culture, demonstrating cell growth inhibition (PMID: 31399568).	31399568

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02279433	Phase I	Taletrectinib	A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b	Completed	USA	0
NCT04919811	Phase II	Taletrectinib	Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC (TRUST-II)	Recruiting	USA \| POL \| ITA \| FRA \| ESP \| CAN	3
NCT06214793	Phase II	Taletrectinib	Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC)	Suspended	USA	0

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