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Roche, Daiichi Sankyo Form CDx Alliance

NEW YORK (360Dx) — Japanese drugmaker Daiichi Sankyo announced today that it has partnered with Roche to develop an immunohistochemistry-based companion diagnostic for one of its investigational breast cancer drugs.

Under the terms of the deal, Basel, Switzerland-based Roche will develop, manufacture, and commercialize an IHC companion diagnostic for identifying HER2 low-expressing metastatic breast cancer patients for enrollment in a phase III study evaluating Daiichi's HER2-targeting antibody drug conjugate [fam-] trastuzumab deruxtecan.

Additional terms were not disclosed.

"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," Gilles Gallant, vice president and global team leader of oncology research and development at Daiichi, said in a statement. "We look forward to collaborating with Roche, a global developer of companion diagnostic tests, and leveraging [Roche's] HER2 (4B5) assay to identify HER2 low patients and help redefine this biomarker as a cell surface target."