· The agreement with Dana-Farber Cancer Institute consists of using HER2DX® to analyze tumor samples from more than 500 patients with early-stage HER2+ breast cancer across three clinical trials (APT, ATEMPT, and DAPHNE).
· The three completed studies were essential in establishing new anti-HER2-based treatment strategies for patients with early-stage HER2+ breast cancer.
· HER2DX® is the world’s first diagnostic test formulated specifically for HER2+ breast cancer.
Barcelona, Spain. April 28th, 2022. REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up that is seeking to revolutionize precision oncology through diagnostic innovation, announced today a new collaborative project with the Dana-Farber Cancer Institute to evaluate the HER2DX® genomic test across three clinical trials (APT, ATEMPT, and DAPHNE) in early-stage HER2+ breast cancer. This disease accounts for 20% of all diagnosed breast tumors.
Today’s agreement represents a step forward in seeking more clinical evidence of the HER2DX® test to help personalize therapy in patients who have early-stage HER2+ breast cancer. In particular, the studies included in the analysis have been instrumental in establishing the concept that less intense and toxic therapies are possible for a subset of patients with this disease. The evaluation of the HER2DX® test in these studies should help refine the best treatment strategy in a setting where uncertainty about the best clinical decision still exists.
“We are thrilled to initiate this research initiative with the Dana-Farber Cancer Institute, one of the most prestigious oncology centers 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,” said Dr. Patricia Villagrasa-Gonzalez, CEO and co-founder of REVEAL GENOMICS®.
Three fundamental trials to support HER2DX® evidence
The clinical trials analyzed with HER2DX® are the APT, the ATEMPT, and the DAPHNE trials. They will provide further information to support the test’s clinical utility in different scenarios by accessing the data of more than 500 patients.
The APT clinical trial, published in the New England Journal of Medicine in 2015, demonstrated that a de-escalation treatment strategy based on weekly paclitaxel during three months and one year of trastuzumab is highly efficacious for a large proportion of patients with stage 1.
The ATEMPT clinical trial, published in the Journal of Clinical Oncology in 2021, 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.
Finally, the DAPHNE clinical trial, presented at the last San Antonio Breast Cancer Meeting in 2021, 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.
“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”, said 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.
“Although the current prognostic and predictive evidence of HER2DX® is strong, it is our commitment to continue exploring the test in clinically relevant cohorts. These analyses will allow us to understand better the current and future clinical utility of the biological heterogeneity of HER2+ breast cancer identified by HER2DX®. I thank Prof. Sara M. Tolaney and her team for this unique opportunity,” commented Dr. Aleix Prat, CSO, and co-founder of REVEAL GENOMICS® .
HER2DX® is the world’s first specialized genomic test for HER2+ breast cancer. It is a 27-gene plus clinical feature-based classifier that predicts the risk of HER2+ breast cancer recurrence in newly diagnosed patients and the likelihood that they will respond to anti-HER2 treatment. HER2DX® uses smart analytical software to stratify patients into risk groups. The HER2DX® algorithm was derived from a dataset of 434 patients and validated in an external dataset of 268 patients. The algorithm has also been validated using data of more than 1,000 patients available from public datasets.
About REVEAL GENOMICSv
REVEAL GENOMICS, S.L. is a biotechnology start-up seeking to change the way biomarkers are used in oncology. It is focused on developing innovative diagnostic tools to define the best therapeutic options for patients with cancer. The company uses pioneering techniques, sophisticated computer applications, and machine learning to reveal new cancer research data.
It is a spin-off of Hospital Clínic de Barcelona, IDIBAPS, the University of Barcelona (UB), and the Vall d’Hebron Institute of Oncology (VHIO).
REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL GENOMICS, S.L.