Therapy Detail
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| Therapy Name | Taletrectinib |
| Synonyms | |
| Therapy Description |
Taletrectinib (DS6051b) 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). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Taletrectinib | DS6051b|DS-6051B|DS-6051|AB-106 | ROS1 Inhibitor 19 Trk Receptor Inhibitor (Pan) 30 | Taletrectinib (DS6051b) 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). |
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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 Taletrectinib (DS6051b) in culture, demonstrating cell growth inhibition (PMID: 31399568). | 31399568 |
| ROS1 rearrange | lung non-small cell carcinoma | predicted - sensitive | Taletrectinib | Phase I | Actionable | In a Phase I trial, Taletrectinib (DS6051b) 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, Taletrectinib (DS6051b) treatment resulted in a partial response in 3 patients and stable disease in 1 patient out of 4 patients with non-small cell lung cancer harboring ROS1 fusions with secondary ROS1 G2032R mutations ((J Clin Oncol 2022 40:16_suppl, 8572; NCT04395677). | detail... |
| ROS1 fusion | lung non-small cell carcinoma | predicted - sensitive | Taletrectinib | Phase I | Actionable | In a Phase I trial, Taletrectinib (DS6051b) 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 July 15 2016 (76) (14 Supplement) CT024). | detail... |
| ROS1 fusion | lung non-small cell carcinoma | predicted - sensitive | Taletrectinib | Phase II | Actionable | In a Phase II trial, Taletrectinib (DS6051b) treatment in non-small cell lung cancer patients with ROS1 fusions resulted in a 90% (36/40) overall response rate (ORR) and 95% disease control rate (DCR) in TKI-naive patients and 47.6% (10/21) ORR and 76.2% DCR in crizotinib-pretreated patients, intracranial ORR of 83.3% (5/6) and DCR of 100% in patients with baseline brain lesions, and partial responses in 3 of 4 patients with secondary ROS1 G2032R mutations (J Clin Oncol 2022 40:16_suppl, 8572; NCT04395677). | detail... |
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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 | ITA | FRA | ESP | CAN | 3 |
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