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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 20 Trk Receptor Inhibitor (Pan) 31 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
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...
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 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...
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 2016;76(14 Suppl):Abstract nr CT024; NCT02279433). detail...
ROS1 fusion lung non-small cell carcinoma predicted - sensitive Taletrectinib Phase II Actionable In a Phase II trial (TRUST-II), Taletrectinib (DS6051b) 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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06214793 Phase II Taletrectinib Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC) Not yet recruiting USA 0
NCT04919811 Phase II Taletrectinib Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC (TRUST-II) Recruiting USA | ITA | FRA | ESP | CAN 4
NCT02279433 Phase I Taletrectinib A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b Completed USA 0


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