On December 6, 2022 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, reported positive results for HER2X in a range of clinical scenarios, demonstrating the test’s reliability (Press release, REVEAL GENOMICS, DEC 6, 2022, View Source [SID1234624860]). This new validation data confirms its suitability for general use in clinical practice.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 HER2DX️ 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.

About HER2DX️

HER2DX️ is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS️ since January 2022, HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX️ is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX️ predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low, and HER2+ breast cancer.