Roche has announced its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay has received CE Mark, making it the first immunohistochemistry (IHC) companion diagnostic test widely available in Europe to identify epithelial ovarian cancer (EOC) patients who may be eligible for targeted treatment with ELAHERE (mirvetuximab soravtansine). ELAHERE, developed by AbbVie, is a first-in-class antibody-drug conjugate (ADC) therapy for the treatment of FRα-positive platinum-resistant ovarian cancer.
Identifying FOLR1 Expression in Ovarian Cancer
The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRα), which is over-expressed in approximately 90 percent of ovarian carcinomas. This expression serves as a predictive biomarker for FOLR1-targeted therapy for EOC patients. The test informs clinicians about the likelihood of potential patient benefit from FOLR1 therapy, aligning with Roche's commitment to personalized healthcare.
Jill German, Head of Pathology Lab at Roche Diagnostics, stated, "This certification will allow us to extend the reach of our innovative diagnostic solutions. The early exemption approval in Germany and Austria highlighted the urgent need for this test. Now, clinicians across Europe can access a critical tool to quickly identify ovarian cancer patients who may be eligible for targeted therapy. By enabling more precise and personalised treatment decisions, we hope this may help improve outcomes for the many women in Europe facing this devastating disease."
Clinical Evidence and Trial Data
The approval is based on results from the SORAYA and MIRASOL clinical studies. Both trials enrolled platinum-resistant epithelial ovarian cancer patients who were FRα-positive by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.
In the single-arm SORAYA trial, 32% of patients demonstrated a partial or complete response to ELAHERE therapy. The MIRASOL trial showed that patients who received ELAHERE demonstrated a significant improvement in progression-free survival compared with IC chemotherapy, representing a 35% reduction in the risk of tumor progression or death (HR 0.65, 95% CI, 0.52-0.81). Patients who received ELAHERE also demonstrated a significant improvement in overall survival compared to chemotherapy, representing a 33% reduction in the risk of death (HR 0.67, 95% CI, 0.50-.0.89).
Impact on Ovarian Cancer Treatment
Ovarian cancer is the eighth leading cause of cancer death in women worldwide. In 2022, 46,232 women in Europe and 209,596 women worldwide died from ovarian cancer. The launch of Roche's first IHC companion test for ovarian cancer in CE countries underscores the company's dedication to advancing personalized healthcare and delivering high medical value solutions to improve patient outcomes.
