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Association details:
| Biomarker: | ROS1 positive |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | taletrectinib (AB-106) (TrkB receptor inhibitor, TrkC kinase inhibitor, ROS1 inhibitor, TrkA receptor antagonist) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study to assess the effect of Taletrectinib in patients with advanced ROS1 Positive non- small cell lung cancer and Other Solid Tumors Estudio para evaluar el efecto de Taletrectinib en pacientes con cáncer de pulmón no microcítico ROS1 positivo avanzado y otros tumores sólidos
Excerpt:
...ROS1 positive solid tumor types other than NSCLC will be enrolled.7. ...
Trial ID:
Title:
Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation
Published date:
12/19/2023
Excerpt:
Innovent Biologics...and AnHeart Therapeutics...announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Priority Review Designation for the New Drug Application (NDA) of taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs....The NDA and Priority Review Designation in China are based on data from the Phase 2 TRUST-I trial (NCT04395677).
Source:
Title:
1373P - Efficacy and safety of taletrectinib in patients (Pts) with ROS1+ non-small cell lung cancer (NSCLC): Interim analysis of global TRUST-II study
Published date:
10/16/2023
Excerpt:
In this ongoing global pivotal phase 2 study, taletrectinib demonstrated robust and consistent clinical activity with TRUST-I, including high response rates and a tolerable safety profile in both TKI-naive and TKI-pretreated pts with ROS1+ NSCLC.
Trial ID:
Source:
Title:
The efficacy and safety of taletrectinib in patients with TKI-naïve or crizotinib-pretreated ROS1-positive non–small cell lung cancer (NSCLC).
Published date:
05/26/2022
Excerpt:
In the TKI-naïve cohort, the confirmed ORR by investigators per RECIST 1.1 was 90.0%: [95%CI: 76.3%; 97.2%] (36/40); and the DCR was 95% [95%CI: 83.1%; 99.4%] (38/40). In the crizotinib-pretreated cohort, the confirmed ORR by investigators was 47.6% [95%CI: 25.7%; 70.2%] (10/21); and DCR was 76.2%...Taletrectinib demonstrated meaningful clinical efficacy in both TKI-naïve and crizotinib-pretreated ROS1 positive NSCLC patients.
DOI:
10.1200/JCO.2022.40.16_suppl.8572
Trial ID:
Source:
Title:
Efficacy of Taletrectinib (AB-106/DS-6051b) in ROS1+ NSCLC: An Updated Pooled Analysis of U.S. and Japan Phase 1 Studies
Published date:
01/01/2021
Excerpt:
The confirmed ORR for ROS1 TKI-naive patients (N = 9) was 66.7% (95% CI: 35.4–87.9) with a disease control rate of 100% (70.1–100)....Taletrectinib (AB106/DS6051b) has a meaningful clinical activity in patients with advanced ROS1+ NSCLC who are ROS1 TKI-naive or crizotinib-refractory...
DOI:
10.1016/j.jtocrr.2020.100108
Trial ID:
Source:
Title:
Efficacy of Taletrectinib (AB-106/DS-6051b) in ROS1+ NSCLC: An Updated Pooled Analysis of U.S. and Japan Phase 1 Studies
Published date:
10/21/2020
Excerpt:
Patients with ROS1+ NSCLC enrolled into two phase 1 studies conducted in United States (U101, NCT02279433) and Japan (J102, NCT02675491) were analyzed...Taletrectinib (AB106/DS6051b) has a meaningful clinical activity in patients with advanced ROS1+ NSCLC who are ROS1 TKI-naive or crizotinib-refractory and a manageable safety profile.
DOI:
10.1016/j.jtocrr.2020.100108
Trial ID:
Source:
Title:
US phase 1 first-in-human study of taletrectinib (DS-6051b/AB-106), a ROS1/TRK inhibitor, in patients with advanced solid tumors
Published date:
06/26/2020
Excerpt:
Patients ≥18 years old with neuroendocrine tumors, with tumor-induced pain, or tumors harboring ROS1/NTRK rearrangements were eligible….Confirmed ORR was 33.3% among the 6 RECIST-evaluable crizotinib-refractory ROS1+ NSCLC patients.
DOI:
10.1158/1078-0432.CCR-20-1630
