VERESCA FOXC1 Phase III Triple Negative Breast Cancer Test Data Presented at ASCO 2024

SAN DIEGO – May 31, 2024 – PRLog — Onconostic Technologies-3N Diagnostics Group (OT/3NDx), a leader in precision oncology diagnostics, today announced study results from the Phase III GEICAM/CIBOMA clinical trial involving patients diagnosed with triple-negative breast cancer (TNBC). In the study, statistically significant clinical benefit in terms of improved disease recurrence-free survival (DRFS) was accurately predicted by VERESCA FOXC1 in those who received extended adjuvant capecitabine therapy. The data was presented in a Rapid Oral Abstract Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held on May 31 – June 4, 2024 at McCormick Place, Chicago, IL.

“The FOXC1 immunohistochemistry (IHC) evaluation results obtained from the GEICAM/CIBOMA trial are relevant for identifying the non-basal TNBC subgroup of patients who can truly benefit from extended adjuvant capecitabine treatment by a single biomarker, associated with gold standard PAM50 non-basal definition,” stated Dr. Miguel Martin, Chairman of GEICAM and principal investigator of the study.

Tumor “plasticity,” which triggers cancer metastasis and accelerates patient death, has previously been unidentifiable, leaving all patients to be treated similarly, resulting in over- or under treatment of patients. The discovery that FOXC1 is a master regulatory gene of cancer plasticity and aggressiveness now enables physicians to better predict cancer metastasis and recurrence risk and better identify which patients may derive the greatest clinical benefit of targeted drug therapy.

Presenting author and lead GEICAM pathologist Dr. Federico Rojo added, “This GEICAM/CIBOMA trial prespecified correlative analysis has demonstrated that the single biomarker FOXC1 (VERESCA) provides high prognostic and predictive value to be effectively applied in the TNBC real-world setting.”

“We are highly encouraged by the results of the study and the demonstrated clinical utility for accurately identifying which patients will require a more aggressive treatment regimen, as well as which patients will derive benefit from treatment,” said Roberto Fagnani, PhD, President and COO of OT/3NDx. “This is such an important advancement in cancer care, which has the potential to significantly enhance treatment outcomes. We look forward to expanding market access and partnering with pharmaceutical companies to bring VERESCA to cancer patients worldwide.”

About VERESCA FOXC1 IHC Precision Oncology Test

OT/3NDx’s patented VERESCA FOXC1 IHC  test identifies tumor biopsy FOXC1 expression levels to guide personalized treatment selection for hormonal therapy, chemotherapy, and immunotherapy. It is the only pan-cancer, tissue-agnostic test to identify those patients who are at heightened risk of suffering metastatic recurrence and helps to identify those who are most likely to benefit from life-saving chemotherapy and targeted therapies. VERESCA has been validated in over 17,000 cancer patients. The test is CE Marked and commercially available to hospitals and oncologists in the European Union and countries recognizing CE Marking.

About OT/3NDx

OT/3NDx is leading precision oncology diagnostics with its versatile VERESCA FOXC1 test. We are dedicated to personalizing cancer diagnostics and therapy for patients, physicians and drug developers worldwide. Our patented technology enables multidisciplinary medical teams to identify previously unidentifiable aggressive cancers, personalize treatment selection, and identify which patients will benefit from targeted drug therapies.

For more information on OT/3NDx, please visit: www.onconostic.com or www.3ndx.com and follow us on LinkedIn.

About GEICAM

Founded in 1995, GEICAM is a not-for-profit organization leading academic breast cancer research in Spain. It has carried out over 160 studies involving more than 67,000 women and men. Now comprising nearly 1,000 clinical researchers based over 200 Spanish hospitals and research centers. Its mission is to promote independent clinical, epidemiological, and translational research in oncology, with a multidisciplinary approach and under quality criteria, to improve health outcomes, as well as prevention, medical education, and the dissemination of the knowledge of this disease to patients and general society.