Reveal Genomics has announced a new collaborative project with the Dana-Farber Cancer Institute to evaluate the HER2DX® genomic test across three clinical trials in early-stage HER2+ breast cancer.
The disease accounts for 20 per cent of all diagnosed breast tumours.
HER2DX®️ is the world’s first specialised genomic test for HER2+ breast cancer.
It is a 27-gene plus clinical feature-based classifier that predicts the risk of HER2+ recurrence in newly diagnosed patients and the likelihood that they will respond to anti-HER2 treatment.
The Barcelona-based biotech start-up is seeking more clinical evidence of the HER2DX® test to help personalise therapy in patients who have early-stage HER2+.
The studies included in the analysis have helped establish that less intense and toxic therapies are possible for a subset of patients with the disease.
The evaluation of the HER2DX® test in these studies should help refine the best treatment strategy.
Dr Patricia Villagrasa-Gonzalez, CEO and co-founder of Reveal Genomics, said:
“We are thrilled to initiate this research initiative with the Dana-Farber Cancer Institute, one of the most prestigious oncology centres globally.
“I am sure that it will provide us with more data confirming what has already been demonstrated, namely the reliability and accuracy of our HER2DX®️ diagnostic test.
“We are very grateful for the speed with which the agreement has been carried out and for the imminent access to all this information, which is undoubtedly a privilege. I am sure that more collaborative projects are still to come.”
Three clinical trials will assess the test in different scenarios by accessing the data of more than 500 patients:
The APT clinical trial demonstrated that a de-escalation treatment strategy based on weekly paclitaxel during three months and one year of trastuzumab is highly effective for a large proportion of patients with stage 1.
The ATEMPT clinical trial demonstrated that 17 cycles of the anti-HER2 antibody drug-conjugate trastuzumab emtansine (T-DM1, Kadcyla, Roche) is highly useful for a large proportion of patients with stage 1, and can help them avoid alopecia when compared to paclitaxel.
The DAPHNE clinical trial demonstrated that a de-escalation of the amount of chemotherapy is feasible in patients with stage 2 or 3 treated with neoadjuvant paclitaxel, trastuzumab and pertuzumab who achieve a pathological complete response at the surgery.
Sara Tolaney, MD, MPH, Chief of Division of Breast Oncology and Associate Director of the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute, said:
“We are excited to be able to explore HER2DX® in our trials of patients with early stage HER2+ breast cancer.
“This assay may be able to help us personalize treatment to the individual patient by better understanding prognosis and being able to predict benefit to HER2-directed therapy.”
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