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Ongoing Clinical Trial Evaluates Efficacy and Safety of TRK Inhibitor Larotrectinib

By: Joshua D. Madera, MS
Posted: Thursday, August 4, 2022

With the approval of the TRK inhibitor larotrectinib in more than 40 countries, many patients with TRK fusion–positive cancers may soon have therapeutic options available to them, according to the open-label, multicenter, multicohort, noninterventional study published in BMC Cancer. This study (ON-TRK) is actively recruiting patients, and thus far ongoing clinical trials seem to show the potential benefit of this agent in terms of both safety and efficacy, according to James C.H. Yang, MD, PhD, of the National Taiwan University Cancer Center, and colleagues.

Adult and pediatric patients with locally advanced or metastatic solid tumors with an NTRK gene fusion will be recruited for the study. All patients must have not received previous treatment with TRK inhibitor therapy. Adult patients will be stratified based on the type of tumor and followed for 2 years, whereas pediatric patients will include those younger than age 18, regardless of tumor type, and will be followed for 5 years.

The current goals of ON-TRK are to evaluate the effectiveness of larotrectinib across all patients included in the study, as well as by tumor type in adult patients. This will be assessed by measuring the overall relative risk, disease control rate, median duration of response, time to response, median overall survival, and progression-free survival. Additionally, treatment-related adverse effects will be measured and analyzed.

“The approval of larotrectinib...marks not only a milestone in its development but also in the development of tumor-agnostic approvals,” commented the investigators.

Disclosure: For full disclosures of the study authors, visit bmccancer.biocmedcentral.com.


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