A Phase 2 clinical trial has revealed that antifibrotic therapy, specifically nintedanib, when combined with chemotherapy, significantly reduces the risk of recurrence in patients with early-stage, HER2-negative breast cancer who have high MeCo Scores. The study, published in Clinical Cancer Research, highlights the potential of the MeCo Score as a predictive biomarker for identifying patients who would benefit from this therapeutic approach.
The research, a collaboration between the University of Arizona Health Sciences and the Spanish National Cancer Research Center (CNIO), involved 130 patients and a median follow-up time of 9.7 years. The results showed that patients with high MeCo Scores who received nintedanib plus chemotherapy experienced a 62% reduction in the risk of recurrence compared to those treated with chemotherapy alone (P<0.05).
The MeCo Score: A Predictive Biomarker
The MeCo Score, a diagnostic test invented at the University of Arizona, assesses tissue stiffening in breast tumors. This stiffening, or fibrosis, has been linked to disease progression and metastasis. The study establishes the MeCo Score as the first clinically validated predictive biomarker for antifibrotic therapy in breast cancer.
Ghassan Mouneimne, PhD, an associate professor at the U of A College of Medicine – Tucson and the U of A Cancer Center, emphasized the significance of the findings. "In the case of this collaboration with our colleagues in Spain, we were able to determine that a drug with no previously known benefit to breast cancer patients, an antifibrotic called nintedanib, led to better outcomes when used in conjunction with traditional chemotherapy," Mouneimne said. "The use of the MeCo Score was crucial to this effort."
Clinical Implications and Future Directions
The study's findings suggest that nintedanib, which is soon to become a generic medicine, could offer a cost-effective treatment option for breast cancer patients identified by the MeCo Score. Adam Watson, CEO of MeCo Diagnostics, noted the "stunning outcome: High MeCo Score patients who received a short course of antifibrotic therapy experienced a remarkable improvement in their long-term survival rate."
A larger, pivotal trial is planned to confirm these results, potentially paving the way for the FDA approval of the MeCo Score and nintedanib as a targeted therapy for breast cancer. Pavani Chalasani, MD, of the George Washington Cancer Center, will serve as the principal investigator for that trial. Furthermore, the MeCo Score's drug-agnostic design allows for the potential repositioning of other antifibrotic drugs for breast cancer treatment.
Addressing Unmet Needs in Breast Cancer Treatment
While current targeted therapies have improved outcomes for some breast cancer patients, there remains a need for more effective and affordable treatments, particularly for those with HER2-negative tumors. This study offers a promising avenue for personalizing treatment based on the MeCo Score, potentially improving long-term survival rates and reducing the financial burden on patients and healthcare systems.
