Therapy Detail
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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 |
|---|---|---|---|---|---|---|---|
| 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 |
| ROS1 rearrange ROS1 G2032R | lung non-small cell carcinoma | sensitive | Taletrectinib | Guideline | Actionable | Ibtrozi (taletrectinib) is included in guidelines as a subsequent therapy for patients with ROS1 rearranged non-small cell lung cancer harboring ROS1 G2032R (NCCN.org). | detail... |
| 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 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 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 | 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 | 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 |
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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) | Active, not 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 |
| NCT07154706 | Phase III | Taletrectinib | Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV) | Recruiting | USA | 0 |
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