On February 2, 2023 Guardant Health Inc. (Nasdaq: GH), a leading precision oncology company, and AnHeart Therapeutics, a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, reported a strategic collaboration on the development, regulatory approval and commercialization of the Guardant360 CDx and Guardant360TissueNext assays as companion diagnostics for taletrectinib in the United States and European Union (Press release, Guardant Health, FEB 2, 2023, View Source [SID1234626769]). Taletrectinib is an investigational ROS1 inhibitor for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

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AnHeart received U.S. Food and Drug Administration Breakthrough Therapy Designation (BTD) for taletrectinib on August 1, 2022, for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who are ROS1 tyrosine kinase inhibitor treatment naïve or previously treated with crizotinib. BTD is intended to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug has the potential to substantially improve clinical outcomes compared with available therapies. The collaboration will focus on the use of the Guardant tests for comprehensive genomic profiling to identify patients with the specific tumor mutations that are targeted by taletrectinib.

"We are very excited to partner with Guardant Health, a global leader in oncology companion diagnostics, to identify NSCLC patients with ROS1 fusion mutations who may benefit from taletrectinib. There is a critical need to improve access to high quality diagnostics to help guide treatment decisions for patients," said Junyuan (Jerry) Wang, Ph.D., chief executive officer of AnHeart Therapeutics. "With our BTD recently granted by FDA, we are committed to advancing taletrectinib for adult patients with advanced or metastatic NSCLC and improving access to convenient biomarker testing in patients who will benefit from our targeted therapy."

The Guardant360 CDx test is FDA-approved to provide comprehensive genomic profiling results from ctDNA in plasma to guide treatment in all solid tumors, including NSCLC. Guardant360 TissueNext provides oncologists with another option to obtain comprehensive genomic profiling results using tissue. Sequencing a broad number of genes to understand the molecular drivers of a patient’s cancer is critical, as the number of genomic alterations associated with targeted treatments continues to grow.

"Our tissue- and blood-based assays play an essential role in the diagnosis of cancers by revealing actionable mutations that can help oncologists quickly match patients to the right targeted treatment," said Helmy Eltoukhy, Guardant Health co-CEO. "We are proud to partner with AnHeart on this important endeavor to help identify lung cancer patients who may benefit from taletrectinib."

About Taletrectinib

Taletrectinib is a novel potential best-in-class next-generation ROS1 inhibitor designed to effectively target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 1 to 2 percent of patients with NSCLC. ROS1 fusions are also observed in several other cancers such as cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers.

Taletrectinib has demonstrated excellent potency against crizotinib resistance, good brain penetration and intracranial antitumor activity, and favorable safety profiles in ROS1 fusion-positive NSCLC patients. In these patients, few neurological adverse events were observed, which likely benefits from the selective inhibition of ROS1 over TRKB by taletrectinib.

Taletrectinib has received FDA Breakthrough Therapy Designation (BTD) for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are ROS1 tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib.

More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) phase 2 trial and the global TRUST-II phase 2 trial may be found by searching clinical trial identifiers NCT04395677 and NCT04919811, respectively at View Source For questions about the ongoing trials, please contact [email protected].