PanTRKare approved in China as adjunct diagnostic to entrectinib in NTRK+ solid tumors

The National Medical Products Administration of China (NMPA) has authorized the marketing of the PanTRKare NTRK1/NTRK2/NTRK3 gene fusion detection kit as a companion diagnostic test to identify patients with solid tumors harboring NTRK gene fusions who may be eligible for treatment with Entrectinib (Entrectinib)-Rozlytrek. This is the first sequencing-based next-generation pan-solid tumor companion diagnostic test approved in China. It is also the first test approved to detect NTRK1/2/3 gene fusions.

The NMPA's approval was based on the results of a multi-center clinical trial conducted at seven hospitals that included patients with 33 tumor types and provided a total of 2,400 clinical samples. In this study, the PanTRKare assay showed high accuracy, sensitivity, and reproducibility and demonstrated its broad applicability across a variety of solid tumors. The assay successfully detected more than 200 unique NTRK fusion variants. Additionally, results from clinical bridging studies investigating entrectinib were highly consistent, demonstrating high overall response rates (ORR) in patients with NTRK fusion-positive disease.

With the NMPA approval of PanTRKare, clinicians across China now have access to an accurate and reliable tool to identify patients with NTRK gene fusions and connect them to effective targeted therapies. This milestone reflects Geneseeq's continued commitment to advancing precision oncology and improving patient outcomes through molecular diagnostic innovation. Geneseeq will continue to drive innovation in oncology diagnostics and advance its mission of making precision medicine accessible to all through global regulatory collaborations, biopharmaceutical partnerships and patient-centered product development.

In 2019, the U.S. Food and Drug Administration granted accelerated approval to entrectinib for the treatment of adult and pediatric patients at least 12 years old with solid tumors harboring NTRK fusions. 2 This approval is reserved for patients with known acquired resistance mutations, patients with metastatic disease or for whom surgical resection would likely result in significant morbidity, and patients who have progressed on therapy or have no other treatment options. This regulatory decision is supported by a comprehensive analysis of data from the Phase 2 STARTRK-2 (NCT02568267), Phase 1 STARTRK-1 (NCT02097810) and Phase 1 ALKA-372-001 (NCT0209710) trials. The analysis showed that the ORR in adult patients with NTRK fusion-positive solid tumors was 57% (95% CI, 43%-71%) (n=54). The duration of response was at least 6 months in 68% of patients and at least 12 months in 45% of patients. The most common cancers evaluated in the trials were sarcoma, non-small cell lung cancer, breast analog-secreting carcinoma, breast cancer, thyroid cancer, and colorectal cancer.

In June 2022, the U.S. Food and Drug Administration approved FoundationOne CDx, a tissue-based genomic profiling test to identify patients with NTRK fusion-positive cancers who may be candidates for treatment with entrectinib. Additionally, in January 2023, regulators approved FoundationOne Liquid CDx as an adjunctive diagnostic to identify patients with NTRK binding-positive solid tumors who may be candidates for treatment with entrectinib but for whom no tissue sample is available.

In addition,In August 2020, the European Commission approved entrectinib for the treatment of adults and patients at least 12 years old with NTRK fusion solid tumors. The approval is also supported by data from the STARTRK-2, STARTRK-1 and ALKA-372-001 trials, as well as the STARTRK-NG Phase 1/2 study (NCT02650401), which investigated the drug's efficacy and safety in pediatric patients.

Reference materials:https://www.onclive.com/view/pantrkare-approved-in-china-as-companion-diagnostic-for-entrectinib-in-ntrk-solid-tumors