On December 14, 2023 AnHeart Therapeutics ("AnHeart"), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer and Foundation Medicine, Inc., reported that the companies have entered a strategic collaboration for the development and regulatory approval of Foundation Medicine’s tissue-based and liquid-based comprehensive genomic profiling tests, FoundationOneCDx and FoundationOneLiquid CDx, as companion diagnostics for AnHeart’s investigational next-generation ROS1 inhibitor, taletrectinib, in the United States (Press release, AnHeart Therapeutics, DEC 14, 2023, View Source [SID1234638586]).

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Taletrectinib is a potential best-in-class ROS1 inhibitor being evaluated for the treatment of patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), an underserved group of lung cancer patients in need of new options. Taletrectinib has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration.

"We are excited to collaborate with Foundation Medicine on the development of both tissue- and liquid-based companion diagnostics to help identify patients who may benefit from taletrectinib," said Lian Li, MD, PhD, AnHeart’s U.S. Chief Medical Officer. "Foundation Medicine’s high-quality testing portfolio and proven regulatory expertise makes them a preferred partner for us as we work to bring this promising next-generation therapy to patients living with ROS1-positive NSCLC."

Foundation Medicine’s portfolio of FDA-approved diagnostic tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Foundation Medicine is the global leader in companion diagnostic approvals. The company has approximately 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing.

"High-quality genomic profiling tests are critical to inform treatment decisions and have become foundational for treating NSCLC as more precision therapies targeting specific genetic alterations, such as ROS1, are being developed," said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. "We look forward to working with AnHeart to deliver swift access to this investigational precision therapy if approved and ultimately to help more patients living with this disease."

About Taletrectinib

Taletrectinib is an investigational oral, potent, brain penetrant, selective, next-generation ROS1 inhibitor being evaluated for the treatment of ROS1-positive NSCLC.

AnHeart is evaluating taletrectinib in patients with advanced or metastatic ROS1-positive NSCLC in two pivotal Phase 2 trials, TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global pivotal trial.

In 2023, AnHeart reported positive interim data from both Phase 2 trials. In both trials, interim results showed taletrectinib shrank tumors by more than 30% in more than 90% of patients with ROS1-positive NSCLC who had not previously received a ROS1 TKI (TKI naïve) and in more than 50% of patients who had previously received a ROS1 TKI (TKI pre-treated), and the responses were durable. Taletrectinib also showed robust intracranial activity in the subgroup of patients with disease that had spread to the brain and in those who had developed resistance mutations to previous ROS1 treatment. Taletrectinib was generally well tolerated with a low incidence of neurological adverse events.

About FoundationOneCDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

About FoundationOneLiquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

About ROS1-Positive NSCLC

Approximately 200,000 people are anticipated to be diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer, in the United States in 2023. It is estimated that approximately 1-2% of people with NSCLC are ROS1-positive. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment. While people with other types of lung cancer have seen great advances, there has been limited progress for people with ROS1-positive NSCLC who remain in need of new options.