- Developed as a predictive biomarker, the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers.
- The new test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE.
- The test is the latest addition to Roche’s portfolio of companion diagnosticsdesigned to provide critical insights that enable more informed clinical decisions and improved patient outcomes.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying epithelial ovarian cancer (EOC) patients who are eligible for targeted treatment with ELAHERE™ (mirvetuximab soravtansine-gynx). ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by ImmunoGen, Inc., approved under FDA’s Accelerated Approval program for the treatment of FRɑ-positive platinum-resistant ovarian cancer.
Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRɑ), is expressed at some level in approximately 90 percent of ovarian carcinomas and serves as a predictive biomarker for FOLR1-targeted therapy for EOC patients.1,2 The new test informs clinicians about the likelihood of potential patient benefit from FOLR1 therapy,3,4 advancing Roche’s commitment to personalised healthcare through innovative solutions that help fit the treatment to the individual.
“We’re proud to expand our women’s health and oncology portfolios through the addition of the first companion diagnostic IHC test for ovarian cancer,” said Jill German, Head of Pathology Lab at Roche Diagnostics. “This test will enable clinicians to make more informed treatment decisions for patients with ovarian cancer by quickly determining whether they qualify for ELAHERE therapy, potentially improving their outcomes.”
The approval is based on the results of the SORAYA clinical study.4 In the study, approximately 35% of ovarian cancer patients expressed high levels of FRα (defined as ≥ 75% tumour cells staining with 2+/3+ intensity) and were considered FRα-positive by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Of the FRα-positive patients, about 32 percent demonstrated a partial or complete response to ELAHERE therapy.5
Ovarian cancer is the eighth most common cancer in women worldwide and patients often have advanced disease when diagnosed.6 Despite improvements in primary therapy, mortality rates remain high, and 80 percent of patients with advanced EOC will have their disease recur.7,8 The five-year relative survival rate for all stages of invasive EOC is 49 percent.9
The launch of Roche’s first companion test for ovarian cancer highlights the company’s commitment, as the world’s leading provider of in vitro diagnostics, to continued innovation and evolution of its products in order to advance personalised healthcare and deliver novel, high medical value solutions that improve patients’ lives. For the current list of labs in the US that offer testing, please visit https://usinfo.roche.com/folr1ihc.html.