Roche’s Newly Approved Companion Diagnostic May Open Treatment Options for HER2-low Patients

The US FDA has given the green light to Roche’s companion diagnostic to identify metastatic breast cancer patients with low HER2 expression who may benefit from Enhertu treatment. 

Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is the first test approved to help assess HER2-low patients for Enhertu eligibility, potentially giving them a new treatment option that could improve their lives. 

Related Article: First Targeted Therapy for HER2-Low Breast Cancer Approved by FDA

Opening Treatment Possibilities For HER2-low Patients

The HER2 receptor protein helps cancer cells grow quickly, and is an important biomarker in treatment selection for cancers such as metastatic breast cancer (mBC). Patients with high levels of HER2 are considered HER2-positive and may be considered for HER2-targeted treatment such as Enhertu (trastuzumab deruxtecan). On the flip side, patients with low HER2 expression are traditionally classified as HER2-negative, barring them from HER2-targeted treatments. As approximately half of all patients with mBC express low levels of HER2, many of them could miss out on the benefits of such treatment. 

Changing views in the medical community are reclassifying many HER2-negative patients as “HER2-low”, allowing them to receive HER2-targeted treatment. In August, Enhertu became the first FDA-approved therapy targeted for this subtype. 

Enhertu’s approval was based on results from the Phase 3 DESTINY-Breast04 trial. In the trial, Enhertu treatment in HER2-low patients, identified by Roche’s test, was shown to reduce the risk of recurrence or death by 50%, with overall gains of six months over the standard of care. 

“Roche is proud to lead the way in HER2 diagnostics through critical innovations that support the identification of patients who may benefit from novel HER2-targeted therapies,” said Thomas Schinecker, CEO of Roche Diagnostics. 

“Previously, metastatic breast cancer patients with a lower level of HER2 expression were considered to be part of the HER2-negative population and had no HER2-targeted treatment options,” he said. 

“Now, they may be eligible for a HER2-targeted therapy, significantly increasing the number of patients who could have improved outcomes.”

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Joy Lin

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