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Reveal Genomics, Dana-Farber Using HER2DX to Analyze Data in Three Breast Cancer Trials

NEW YORK – Reveal Genomics on Thursday said it has launched a project with the Dana-Farber Cancer Institute to use its HER2DX test to analyze data within three trials and improve understanding of early-stage HER2-positive breast cancer patients and gain insights into optimal treatment strategies.

The partners will use HER2DX to retrospectively analyze data from more than 500 breast cancer patients enrolled in the APT, ATEMPT, and DAPHNE trials with the goal of helping oncologists treat individuals for whom the best therapeutic strategy is unclear. Barcelona, Spain-based Reveal and Dana-Farber in Boston said in a statement that the three studies have helped establish that patients with HER2-positive tumors, which comprise 20 percent of breast cancer cases, can be treated with less intense and toxic treatments.

The APT trial showed that de-escalating paclitaxel while giving Roche's Herceptin (trastuzumab) for a year and three months benefits early-stage patients. In ATEMPT, researchers showed that 17 cycles of Roche's antibody-drug conjugate Kadcyla (trastuzumab emtansine) benefits a large proportion of Stage I patients compared to paclitaxel and keeps them from experiencing adverse events like alopecia. DAPHNE showed the feasibility of de-escalating chemotherapy in Stage II/III patients who achieve a pathologic complete response after surgery and go on to receive neoadjuvant paclitaxel, Herceptin, and Roche's Perjeta (pertuzumab).

By analyzing data from these studies, "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," Sara Tolaney, chief of the division of breast oncology and associate director of Dana-Farber's Susan F. Smith Center for Women's Cancers, said in a statement.

HER2DX analyzes 27 genes and clinical features of newly diagnosed HER2-positive breast cancer patients and predicts their risk of recurrence and the likelihood of treatment response. Reveal recently commercialized the test in Europe and has said it is seeking partnerships to make it available in the US.

"Although the current prognostic and predictive evidence of HER2DX is strong, it is our commitment to continue exploring the test in clinically relevant cohorts," Reveal CSO Aleix Prat said in a statement. "These analyses will allow us to understand better the current and future clinical utility of the biological heterogeneity of HER2-positive breast cancer identified by HER2DX."