New HER2 Diagnostic Test Coming From Two Drug Manufacturers

By David Costill
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Roche and Daiichi Sankyo recently announced that they have entered into an agreement to develop a new HER2 low companion diagnostic test.

According to the press release, the new diagnostic test would quickly identify patients with HER2 low expressing metastatic breast cancer. The new diagnostic test will be developed and commercialized for use worldwide. The two manufacturers plan to use the test in order to enroll patients in phase 3 study evaluating the safety and efficacy of trastuzumab deruxtecan, an investigational anti-HER2 agent.


Diagnostic test. Source: iStock

“This agreement is an important milestone in our [fam-] trastuzumab deruxtecan development program as we continue to evaluate its potential as a treatment strategy for breast cancers that express low levels of HER2 as there are currently no approved anti-HER2 therapies available for these patients,” Gilles Gallant, BPharm, PhD, Vice President, DS-8201 Global Team Leader, Oncology Research and Development, Daiichi Sankyo, said in the press release.

The investigational agent [fam-] trastuzumab deruxtecan is currently in phase 3 clinical trials in order to determine safety and efficacy. The FDA recently granted the agent a Breakthrough Therapy designation.

The trials DESTINY-Breast02 is comparing [fam-] trastuzumab deruxtecan versus investigator’s choice in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with standard of care. Additionally, DESTINY-Breast03 is comparing [fam-] trastuzumab deruxtecan (DS-8201) versus ado-trastuzumab emtansine in the same patient population, previously treated with trastuzumab and taxane.

“We look forward to collaborating with Roche, a global developer of companion diagnostic tests, and leveraging the market-leading HER2 (4B5) assay to identify HER2 low patients and help redefine this biomarker as a cell surface target,” Gallant added.