· The HER2DX® risk score predicted long-term survival outcomes in clinically low-risk patients in APT and ATEMPT clinical trials.
· The HER2DX® pCR score predicted response to chemotherapy in combination with trastuzumab and pertuzumab in DAPHNe and GOM clinical trials.
· HER2DX®️ is the first genomic test in the world specialized in HER2+ breast cancer and has been marketed by REVEAL GENOMICS® since January 2022.
San Antonio, Texas. December 6, 2022. REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, today announced positive results for HER2X® in a range of clinical scenarios, demonstrating the test’s reliability. This new validation data confirms its suitability for general use in clinical practice.
The results of 4 studies (APT, ATEMPT, DAPHNe and GOM) have been made public during the San Antonio Breast Cancer Symposium (SABCS), held from December 6 to 10 in San Antonio, Texas (USA).
“We are delighted to share important new results for HER2DX® during SABCS, which confirm the robust ability of the test to predict long-term survival and response to anti-HER2 therapy. The HER2DX® risk score and pCR score have now been validated across more than 1800 and 800 patients, respectively,” says Dr. Aleix Prat, Co-founder and CSO of REVEAL GENOMICS®.
“These extraordinary results will undoubtedly be key to achieving our goal of making HER2DX® available globally and reaching all patients with HER2+ breast cancer. We are very excited about what the future holds for us as a company,” adds Dr. Patricia Villagrasa-Gonzalez, Co-founder and CEO of REVEAL GENOMICS®.
APT and ATEMPT studies: confirming the HER2DX®️ risk score
The analysis of the HER2DX® in the APT and ATEMPT studies is the result of the agreement between REVEAL GENOMICS® and Dana-Farber Cancer Institute (US), consisting of using the test to analyze tumor samples from 471 patients with early-stage HER2+ breast cancer from both Phase II trials.
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 stage 1 patients.
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 stage 1 patients, and can help them avoid alopecia when compared to paclitaxel.
The results presented at SABCS 2022 during a Spotlight Session show that HER2DX® risk score was significantly associated with relapse-free interval despite the low number of events in both studies. Overall, these results show that HER2DX® can reliably identify patients who might be ideal candidates for de-escalation of systemic therapy.
DAPHNe and GOM studies: confirming the HER2DX® pCR score
The analysis of the HER2DX® in DAPHNe and GOM studies is the result of the agreement between REVEAL GENOMICS®and Dana-Farber Cancer Institute (US) and Hospital Universitario Gregorio Marañón (Spain), respectively, consisting of using the test to analyze tumor samples from 235 patients with early-stage HER2+ breast cancer from both trials.
The DAPHNe clinical trial was a single-arm prospective academic phase II trial in which patients with treatment-naïve stage II-III HER2+ breast cancer received a de-escalated neoadjuvant regimen of weekly paclitaxel for 12 cycles along with trastuzumab and pertuzumab (THP) every 3 weeks for 4 cycles. The results of this study have prompted the COMPASS-HER2-pCR study, led by ECOG-ACRIN, which aims to recruit more than 2000 patients.
The GOM study is a prospective observational study, ongoing since 2018, of consecutive patients with newly diagnosed stage I III HER 2 breast cancer candidates for 6 cycles of neoadjuvant docetaxel, carboplatin and trastuzumab (TCH) or TCH plus pertuzumab (TCHP) across 7 public hospitals in Spain.
The results presented at SABCS 2022 show that HER2DX® pCR scores were found to strongly predict pCR in both trials, independently of known clinical-pathological variables and intrinsic subtype. It was also observed that the group with high pCR likelihood according to HER2DX® benefited from the inclusion of pertuzumab to trastuzumab-based neoadjuvant chemotherapy, in contrast to the group with low pCR. Notably, the pCR rate of the DAPHNe group of patients with a HER2DX® high pCR likelihood HER2DX® result was 93%.
Overall, these results show that HER2DX® pCR score can reliably identify patients who might be ideal candidates for neoadjuvant paclitaxel, trastuzumab and pertuzumab.