Roche has announced that 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 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 FRɑ-positive platinum-resistant ovarian cancer.
The CE Mark approval follows earlier pre-authorization in Germany and Austria, which allowed clinicians and patients in those countries access to the test ahead of the broader European approval. This early access underscored the urgent need for the diagnostic tool.
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 (FRɑ), which is overexpressed in most ovarian cancers. Approximately 90 percent of ovarian carcinomas express FOLR1 at some level, making it a predictive biomarker for FOLR1-targeted therapy in EOC patients.
"This certification will allow us to extend the reach of our innovative diagnostic solutions," said Jill German, Head of Pathology Lab at Roche Diagnostics. "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 Supporting ELAHERE
The approval is based on results from the SORAYA and MIRASOL clinical studies. Both trials enrolled platinum-resistant epithelial ovarian cancer patients who were FRɑ-positive as determined 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 demonstrated a significant improvement in progression-free survival with ELAHERE compared to investigator's choice chemotherapy, representing a 35% reduction in the risk of tumor progression or death (HR 0.65, 95% CI, 0.52-0.81). Patients receiving ELAHERE also showed a significant improvement in overall survival compared to chemotherapy, with a 33% reduction in the risk of death (HR 0.67, 95% CI, 0.50-0.89).
Ovarian Cancer Statistics
Ovarian cancer is the eighth leading cause of cancer death in women worldwide, accounting for 4.7% of all cancer deaths in women. In 2022, 46,232 women in Europe and 209,596 women worldwide died from ovarian cancer.
