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TRUST-II: a global phase II study of taletrectinib in ROS1-positive non-small-cell lung cancer and other solid tumors

Misako Nagasaka1,2, Yuichiro Ohe3, Caicun Zhou4

  • 1University of California Irvine School of Medicine, Orange, CA, USA.

Future Oncology (London, England)
|March 6, 2023
PubMed

Insights

Taletrectinib shows promise for ROS1-positive lung cancer, addressing resistance and brain metastases with fewer side effects. The TRUST-II study evaluates its global efficacy and safety in advanced solid tumors.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Crizotinib and entrectinib are approved for ROS1-positive non-small-cell lung cancer (NSCLC).
  • Unmet needs include resistance mutations, brain metastasis, and neurological side effects.
  • Taletrectinib was developed to overcome these limitations.

Purpose of the Study:

  • To describe the rationale and design of the global phase II TRUST-II study.
  • To evaluate taletrectinib in patients with locally advanced/metastatic ROS1-positive NSCLC and other solid tumors.

Main Methods:

  • Global phase II clinical study.
  • Primary endpoint: confirmed objective response rate.
  • Secondary endpoints: duration of response, progression-free survival, overall survival, and safety.

Main Results:

  • Interim data from the TRUST-I study demonstrate taletrectinib's efficacy in improving outcomes.
  • Taletrectinib shows potential to overcome resistance and address brain metastasis.
  • Fewer neurological adverse events were observed.

Conclusions:

  • Taletrectinib is a promising therapeutic candidate for ROS1-positive solid tumors.
  • The TRUST-II study will provide further global data on its efficacy and safety.
  • Taletrectinib may offer an improved treatment option for patients with unmet needs.
Keywords:
ROS1 kinase fusionROS1G2032RTRKBbrain metastasisbrain penetrationintracranial antitumor activityneoplasm drug resistancenon-small-cell lung cancertaletrectinibtyrosine kinase inhibitors

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