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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

AnHeart Therapeutics Receives FDA Breakthrough Therapy Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer

Published date:
08/03/2022
Excerpt:
AnHeart Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational ROS-1 inhibitor taletrectinib for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)...The FDA decision was supported by the preliminary clinical data of taletrectinib from an ongoing Phase 2 trial (TRUST)...In 67 evaluable ROS1 TKI-naïve patients with ROS1 fusion-positive NSCLC, the confirmed objective response rate (cORR) and disease control rate (DCR) was 92.5% and 95.5%, respectively. In 38 evaluable crizotinib-pretreated patients, the cORR and DCR were 50% and 78.9%, respectively.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

Excerpt:
...Evidence of ROS1 fusion by a validated assay....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

Excerpt:
...Positivity of ROS1 fusion is determined by the local qualified laboratories by using the FISH, RT-PCR or NGS assay, and the subject must provide archival tumor tissue sample for the confirmation by a sponsor-designated central laboratory 4....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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:
...Evidence of ROS1 fusion in tumor tissue determined by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent diagnostic laboratories. ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Innovent Biologics and AnHeart Therapeutics Receive NMPA Breakthrough Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer

Published date:
03/01/2022
Excerpt:
Innovent Biologics, Inc...with AnHeart Therapeutics ("AnHeart")...jointly announced that the Center for Drug Evaluation (CDE) of China's Nation Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to taletrectinib (Innovent R&D code: IBI-344, Anheart R&D code: AB-106) for both first-line tyrosine kinase inhibitor (TKI)-naïve and second-line TKI-pretreated patients with ROS1-positive non-small cell lung cancer (NSCLC)....The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Taletrectinib (AB-106; DS-6051b) in metastatic non-small cell lung cancer (NSCLC) patients with ROS1 fusion: Preliminary results of TRUST

Published date:
05/28/2021
Excerpt:
Taletrectinib demonstrated promising clinical activity with high ORR and good tolerability in ROS1 fusion positive NSCLC patients.
DOI:
10.1200/JCO.2021.39.15_suppl.9066
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Taletrectinib (AB-106; DS-6051b) in metastatic non-small cell lung cancer (NSCLC) patients with ROS1 fusion: Preliminary results of TRUST.

Published date:
05/19/2021
Excerpt:
The ROS1 TKI naïve or crizotinib pre-treated NSCLC patients with ROS1 fusion were treated with taletrectinib 400 or 600 mg QD….ORR by investigator among the crizotinib naïve pts with tumor assessment (N = 11) was 100% (95% CI, 72%-100%)….Taletrectinib demonstrated promising clinical activity with high ORR and good tolerability in ROS1 fusion positive NSCLC patients.
DOI:
10.1200/JCO.2021.39.15_suppl.9066
Trial ID: