COMPANY:

Reveal Genomics

"Reveal Genomics... today announced the publication of the study 'HER2DX and survival outcomes in early-stage HER2-positive breast cancer: an individual patient-level meta-analysis' in The Lancet Oncology.In the most comprehensive analysis to date of the HER2DX genomic test, investigators evaluated its prognostic utility across more than2,500 patients with early-stage HER2-positive (HER2+) breast cancer. Data from 11 international studies, including APT, ATEMPT, CALGB40601, DAPHNe, and PHERGain, were harmonized to assess the ability of HER2DX to stratify long-term risk and inform personalized treatment strategies in both neoadjuvant and adjuvant settings."

P=NA | N=9,638 | "This study highlights the clinical value of REVEAL GENOMICS' immune gene combinations, which identify key immune cells such as B-cells and T-cells linked to recurrence, metastasis, and treatment response in HER2-positive (HER2+) and triple-negative breast cancer (TNBC)....Analyzing comprehensive gene expression and clinical data from 9,638 patients across three distinct cohorts, a significant association was observed between immune expression and OS in patients without a documented relapse, independently of cancer subtype, tumor stage, or nodal status. Overall, patients with high immune tumors, characterized by significant immune system activity within its microenvironment, experienced a 41-47% reduction in mortality risk compared to low immune tumors."

"Reveal Genomics, S.L...and the Istituto Europeo di Oncologia (IEO) today announced the start of an impact study of the HER2DX® test, the first genomic test in the world specialized in HER2+ breast cancer...The project, entitled "Prospective observational monocentric study to evaluate the impact of the HER2DX® assay on treatment decisions in patients with early-stage HER2+ breast cancer: HER2-BREAST-DX," aims to determine the impact of applying the test in medical decisions regarding treatment for patients diagnosed with localized HER2+ breast cancer (stage I-IIIA). These patients are candidates for either neoadjuvant treatment (prior to surgery) or adjuvant treatment (post-surgery). The project therefore seeks to advance the personalization of treatments."

"REVEAL GENOMICS...today announced both the development and the clinical validation of TNBCDX, the first genomic test designed specifically for patients with early-stage TNBC. This dual milestone will be presented at the ESMO Congress 2024 in Barcelona (Spain)...Across two independent validation studies with 418 patients, the TNBCDX scores showed a strong association with pathological complete response (pCR), distant disease-free survival (DDFS), and overall survival (OS), providing a more refined risk stratification. Notably, the TNBCDX test outperformed tumor-infiltrating lymphocytes (TILs) in predicting both pCR and survival outcomes...The results will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona (Spain) on Saturday, September 14th."

P3 | N=808 | CLEOPATRA (NCT00567190) | Sponsor: Genentech, Inc. | "REVEAL GENOMICS S.L...released further evidence supporting HER2DX, the world’s first specialized genomic test for HER2+ breast cancer. These results were obtained in collaboration with F. Hoffmann-La Roche Ltd (Basel, Switzerland) after analyzing HER2DX in tumor samples from the CLEOPATRA phase III clinical trial (NCT00567190)....For the first time, the investigators evaluated the ability of the HER2DX ERBB2 mRNA score to predict long-term survival outcomes in 214 patients treated with THP in the pivotal CLEOPATRA phase III trial3. The results showed a strong association of HER2DX ERBB2 mRNA score with PFS and OS....Detailed results of this study will be presented at an upcoming medical congress and submitted for publication."

"REVEAL GENOMICS, S.L... announced the results of the study 'HER2DX ERBB2 mRNA assay Following Trastuzumab-Based Chemotherapy in HER2-Positive Advanced Gastric Cancer' presented at ESMO Gastrointestinal Cancers Congress 2024 in Munich, showing that HER2DX genomic test demonstrates significant potential in refining patient selection for trastuzumab-based chemotherapy in HER2-positive advanced gastric cancer."

"REVEAL GENOMICS, S.L...has announced the start of a prospective study in collaboration with the Dana-Farber Cancer Institute (Dana-Farber). This trial will evaluate the turnaround time of the HER2DX genomic test to determine its feasibility in clinical practice in the US....The study will also examine how the HER2DX test results influence therapeutic decisions by Dana-Farber physicians for patients with stage I-III HER2+ breast cancer, and the confidence levels of both patients and physicians before and after the test."

"REVEAL GENOMICS...announced the forthcoming prospective validation of its groundbreaking diagnostic tool HER2DX® within the framework of the ongoing CompassHER2 pCR Trial."

P=NA | N=NA | "MEDSIR...presenting the results of two sub-studies focused on biomarkers: transFal, focused on patients with HR+/HER2- advanced breast cancer and METSGain, centered on patients with early breast cancer....Notably, high expression of Ki67 and CDK6, along with elevated ctDNA density at baseline, were correlated with shorter progression-free survival and overall survival. These findings illuminate potential avenues for understanding and overcoming resistance to CDK4/6 inhibitors, marking a significant step forward in personalized cancer treatment....Notably, patients with high-risk scores at surgery and less molecular changes after anti-HER2 therapy were more likely to develop metastasis, further highlighting the potential of HER2DX tool developed by REVEAL GENOMICS S.L. in guiding treatment decisions for HER2+ early breast cancer patients."

"REVEAL GENOMICS, S.L...has announced the start of the DEFINITIVE study, led by FRCB-IDIBAPS, representing the first prospective trial for HER2DX. This landmark study will be pivotal in bolstering the clinical validations already acquired for HER2DX. The study seeks to secure the prospective validation for endorsement by clinical guidelines and ensure recognition and reimbursement across Europe."

P2 | N=486 | PARSIFAL (NCT02491983) | Sponsor: MedSIR | "MEDSIR, a company specializing in the strategic design of independent clinical research, sponsored PARSIFAL phase II trial (NCT02491983), which randomized 486 patients with HR+/HER2- metastatic breast cancer to receive first-line palbociclib with either fulvestrant or letrozole; DNADX^® was evaluated in 122 pre-treatment plasma samples. The liquid biopsy-based DNADX^® subtypes exhibited a significant association with both progression-free survival (PFS) and overall survival (OS), revealing their potential to guide therapy and follow-up in patients with endocrine-sensitive HR+/HER2- advanced breast cancer....'We are pleased to announce that the Spanish Ministry of Science and Innovation has granted funding for the analytical and clinical validation of DNADX®.'"

"REVEAL GENOMICS...announced the inclusion of its HER2DX test in the clinical guidelines for early-stage breast cancer prepared by the Spanish Society of Medical Oncology ( SEOM)."