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Business Wire
27-05-2025
- Business
- Business Wire
ASCO 2025: REVEAL GENOMICS Unveils New HER2DX Data From 800+ Patients
BARCELONA, Spain--(BUSINESS WIRE)--REVEAL GENOMICS, S.L., a biotechnology company advancing precision oncology through biomarker innovation, today announced the presentation of four independent studies at the 2025 ASCO Annual Meeting. The studies, involving more than 800 patients, evaluated the clinical utility of its flagship test, HER2DX, in early-stage HER2-positive (HER2+) breast cancer. The studies presented at the 2025 ASCO Annual Meeting, involving more than 800 patients, evaluated the clinical utility of HER2DX, in early-stage HER2-positive (HER2+) breast cancer. Share The four studies, CompassHER2 pCR, BionHER, RESPECT and DFCI, validate HER2DX as a powerful genomic tool for predicting response to therapy and long-term prognosis, addressing critical questions. The findings, which provide valuable insights for optimizing treatment strategies in early-stage HER2+ breast cancer and metastatic breast cancer, will be shared in oral and poster sessions led by academic investigators from the U.S., Europe, and Japan. CompassHER2 pCR or EA1181 (U.S.): HER2DX determining response to THP-based de-escalated therapy This study is led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), a scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer, comprising nearly 1,400 member institutions in the U.S. and around the world. HER2DX was evaluated as a secondary aim as part of a pre-specified, prospectively planned analysis embedded in the CompassHER2 pCR trial, also known as EA1181 (NCT04266249). This large, prospective multicenter phase II trial is assessing neoadjuvant taxane, trastuzumab, and pertuzumab (THP) in more than 2,000 patients with stage II–III HER2+ breast cancer, without the use of anthracyclines, cyclophosphamide, and carboplatin. The HER2DX assay was defined as a key secondary endpoint, with profiling of all available baseline samples planned. Among 569 patients assessed to date for the HER2DX pathologic complete response (pCR) score, those with higher scores achieved significantly greater pCR rates, independent of estrogen receptor (ER) status. These findings confirm the ability of HER2DX to identify tumors more likely to respond to THP. Importantly, additional results are expected from this trial, as patients continue to be followed for the primary endpoints of 3-year survival outcomes, and the study team plans to profile many more baseline samples. ' The ability to predict response to THP is extremely valuable,' said Dr. Nadine Tung, Director of Breast Medical Oncology at Beth Israel Deaconess Medical Center, Professor of Medicine at Harvard Medical School, and Principal Investigator of the CompassHER2 pCR (EA1181) trial. ' HER2DX provides a biology-driven tool that contributes to the selection of patients who can safely reduce chemotherapy, something we've long needed in HER2-positive early breast cancer.' ' It is encouraging to see the assay's performance in both ER-positive and ER-negative subgroups,' added Dr. Tung. ' The plan is to profile all available samples from the trial, and these early data already provide valuable insights for guiding treatment selection.' BionHER trial (Spain): Validation of HER2DX-guided de-escalation strategy The BionHER phase II trial (NCT05912062) evaluated HER2DX in 83 patients with stage I–III HER2+ breast cancer treated with neoadjuvant THP for up to 15 weeks at the Catalan Institute of Oncology (ICO L'Hospitalet, Barcelona, Spain). HER2DX was successfully performed in all baseline FFPE tumor samples. The HER2DX pCR score was significantly associated with pCR with a performance AUC of 0.835. Patients classified by HER2DX pCR score into low, medium, and high groups had increasing pCR rates of 13.3%, 51.6%, and 81.8%, respectively. HER2DX outperformed traditional biomarkers, such as ER, Ki-67, and tumor-infiltrating lymphocytes, in predicting pCR. ' HER2DX is transforming the way we approach treatment selection in HER2-positive disease,' said Dr. Sònia Pernas, head of the breast cancer unit at ICO L'Hospitalet, and Principal Investigator of the BionHER study. ' By identifying tumors more likely to respond to dual HER2 blockade with a single taxane, we are increasingly able to personalize treatment intensity without compromising efficacy.' RESPECT trial (Japan): a response for an unrepresented population Trans-RESPECT is a prespecified translational analysis within the Japanese RESPECT non-inferiority trial (NCT01104935), in which 266 patients aged 70–80 years with stage I-III HER2+ breast cancer were randomized to receive adjuvant trastuzumab with or without chemotherapy (Sawaki et al. J Clin Oncol 2020). HER2DX was assessed in 154 of these patients, with a median follow-up of 9.1 years. The HER2DX risk score effectively stratified patients by 10-year relapse-free survival (86.6% in the low-risk group vs. 68.4% in the high-risk group) and overall survival (94.5% vs.72.5%). Notably, chemotherapy conferred an overall survival benefit only in tumors classified as pCR-high by HER2DX, with a significant interaction p-value of 0.045. ' HER2DX provided clear long-term prognostic information in this elderly population,' said Dr. Kazuki Nozawa, Lead Investigator of Trans-RESPECT, from the Department of Advanced Clinical Research and Development and the Department of Breast Surgery at Nagoya City University Graduate School of Medical Sciences. ' Importantly, its ability to help identify which patients may benefit from adjuvant chemotherapy is highly relevant to clinical decision-making. Older patients with HER2DX low-risk scores, particularly those classified as pCR-low or -medium, appear to be ideal candidates for trastuzumab alone, without chemotherapy.' DFCI T-DXd study (U.S.): predicting survival outcome to T-DXd Dana-Farber Cancer Institute (DFCI) conducted a retrospective analysis of 41 patients with metastatic breast cancer (25 HER2-positive, 16 HER2-negative) treated with trastuzumab deruxtecan (T-DXd) monotherapy between 2017 and 2023. The HER2DX HER2 signature score was significantly associated with time to next treatment (p=0.001). When stratified into tertiles, patients in the highest tertile had a median time to next treatment of 12.03 months compared to 4.7 months in the lowest tertile (p=0.02). ' Quantitative measurement of HER2 amplicon expression by HER2DX is a key determinant of T-DXd activity in metastatic breast cancer,' said Dr. Sara M. Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute. She added, ' Further evaluation of this genomic test in ongoing T-DXd trials is warranted.' HER2DX makes a significant impact at ASCO 2025 ' ASCO 2025 marks a pivotal milestone for HER2DX,' said Dr. Aleix Prat, Chief Scientific Officer and co-founder of REVEAL GENOMICS. 'This test is demonstrating clinical value in real-world practice across continents and care settings, assisting in the tailoring of chemotherapy intensity in the neoadjuvant setting and supporting chemotherapy-free decisions in the adjuvant setting.' Patricia Villagrasa, CEO and co-founder, added, ' HER2DX was developed with HER2+ disease at its core, and these four high-quality, independent studies reinforce its clinical value. As we continue to grow globally, this is a clear example of how REVEAL GENOMICS is turning cutting-edge science into meaningful solutions that advance personalized cancer care worldwide.' About HER2DX HER2DX is the world's first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer. HER2DX 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. HER2DX ®️ 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. About REVEAL GENOMICS REVEAL GENOMICS, S.L., together with its U.S. subsidiary REVEAL GENOMICS, Inc., is a biotechnology company dedicated to redefining the role of biomarkers in oncology. The company focuses on developing innovative diagnostic tools that optimize therapeutic decision-making for individuals with cancer. By leveraging advanced genomic technologies, sophisticated computational algorithms, and machine learning, REVEAL GENOMICS generates novel insights into cancer biology and treatment response. academic and clinical institutions to advance precision oncology. REVEAL GENOMICS, S.L. is a spin-off company of Hospital Clínic of Barcelona, IDIBAPS, the University of Barcelona (U.B.), and the Vall d'Hebron Institute of Oncology (VHIO). REVEAL GENOMICS ® and HER2DX ® are registered trademarks of REVEAL GENOMICS, S.L.
Associated Press
14-04-2025
- Business
- Associated Press
REVEAL GENOMICS and Ona Therapeutics Join Forces to Advance Next-generation Cancer Treatment
BARCELONA, Spain--(BUSINESS WIRE)--Apr 14, 2025-- REVEAL GENOMICS and Ona Therapeutics today announced a strategic collaboration aimed at accelerating the clinical development of ONA-255, a next-generation ADC designed to enhance the precision and efficacy of cancer treatment across multiple tumor types. This press release features multimedia. View the full release here: ONA-255 is positioned to be a first-in-class molecule against a novel ADC target present in multiple, prevalent solid tumor types. Ona has privileged insight of the target as a hallmark of molecular adaptation in advanced diseases and its unique function as a universal driver of resistance to various therapies. ONA-255 is an ADC tailor-made to match the design of the molecule to the extraordinary biology of the target to deliver exceptionally potent drug against recalcitrant tumors, especially resistant clones for deeper and more durable responses. At the heart of this collaboration is Dr. Aleix Prat, Co-Founder and Chief Scientific Officer of REVEAL GENOMICS. A globally recognized expert in precision oncology and drug development, Dr. Prat played a key role in identifying the ONA-255 drug target and generating, in collaboration with Ona Therapeutics and Dr. Roger Gomis, the critical preclinical data necessary for its clinical advancement. He also serves as the head of Ona Therapeutics' advisory board. As a leader in genomic innovation, REVEAL GENOMICS will conduct a comprehensive molecular analysis of tumor and blood samples from the ONA-255 phase 1-2 clinical trial as part of this strategic collaboration. Leveraging proprietary technologies and advanced computational algorithms, the company will decode key molecular and genomic biomarkers to reveal insights into tumor biology, the immune microenvironment, and response mechanisms to ONA-255. This pioneering work will help define patient populations, identify predictive biomarkers, and deepen the understanding of ONA-255's mechanism of action—accelerating its clinical development and opening new therapeutic avenues. To advance this partnership, Ona Therapeutics—working in collaboration with the U.S. subsidiary of REVEAL GENOMICS—has been awarded a grant from CDTI ( Centro para el Desarrollo Tecnológico y la Innovación ), a public entity under the Spanish Ministry of Science, Innovation, and Universities that promotes technological innovation and development. The grant is funded by the Plan de Recuperación, Transformación y Resiliencia – Funded by the European Union NextGenerationEU. Valerie Vanhooren, Co-Founder and CEO of Ona Therapeutics, added, " ADCs have transformed cancer treatment; however, the technology has been applied to a limited number of tumor targets. These limitations restrict the number of patients who can benefit from treatments and highlight the critical need to identify new broadly expressed tumor targets. Ona's tailor-designed ADCs have the potential to define new treatment paradigms and patient populations, resulting in a clear benefit for patients with cancer. This partnership with REVEAL GENOMICS combines Ona's ADC experience with cutting-edge diagnosticswith the goal to transform the treatment landscape for aggressive solid tumors.' Patricia Villagrasa, Co-Founder and CEO of REVEAL GENOMICS, stated, " Ona Therapeutics is at the forefront of developing next-generation cancer therapies. This collaboration marks a key milestone in combining advanced diagnostics with innovative treatments, reinforcing the strategic value of integrating biomarker science early in drug development. It also underscores REVEAL GENOMICS's leadership in driving biomarker strategy and our commitment to shaping new business models that bring precision oncology closer to patients.' Dr. Aleix Prat commented, " For further information visit: For further information visit: View source version on Further information: Adriana Herrera,[email protected] KEYWORD: EUROPE SPAIN UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE BIOTECHNOLOGY RESEARCH ONCOLOGY HEALTH CLINICAL TRIALS OTHER HEALTH SOURCE: REVEAL GENOMICS Copyright Business Wire 2025. PUB: 04/14/2025 08:05 AM/DISC: 04/14/2025 08:06 AM
