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Roche’s VENTANA FOLR1 Test Gets CE Mark, Paving the Way for Enhanced Ovarian Cancer Treatment
New Diagnostic Tool for Targeted Therapy
- 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.
- This test identifies patients eligible for targeted treatment with ELAHERE.
- The certification follows an early exemption approval granted by regulators in Germany and Austria earlier this year.
TUCSON, Ariz., Nov. 18, 2024 /PRNewswire/ — Roche (RO, RHHBY) announced today that it has received the CE Mark for its VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay. This marks the introduction of the first immunohistochemistry (IHC) companion diagnostic test available in Europe, aimed at identifying epithelial ovarian cancer (EOC) patients eligible for targeted treatment with ELAHERE® (mirvetuximab soravtansine). ELAHERE is a pioneering antibody-drug conjugate (ADC) therapy developed by AbbVie for treating FRɑ-positive platinum-resistant ovarian cancer.
This certification comes on the heels of earlier news that the VENTANA FOLR1 (FOLR1-2.1) test had secured pre-authorization in Germany and Austria. This early exemption allowed patients and clinicians in those countries to access the test before the CE Mark was granted.
According to Jill German, Head of Pathology Lab at Roche Diagnostics, “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 crucial tool to identify ovarian cancer patients who may benefit from targeted therapy. By enabling more precise treatment decisions, we hope to improve outcomes for women facing this disease.”
The folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRɑ), appears in about 90% of ovarian carcinomas. This predictive biomarker helps determine the potential benefit of FOLR1-targeted therapy for EOC patients.1,2
Ovarian cancer ranks as the eighth leading cause of cancer death among women globally, accounting for 4.7% of all cancer fatalities in women. It is recognized as one of the deadliest gynecological cancers worldwide, with 46,232 women in Europe and 209,596 women worldwide losing their lives to this disease in 2022.5
Roche’s introduction of its first IHC companion test for ovarian cancer in CE-marked countries underscores its commitment as a leading provider of in vitro diagnostics. The company aims to further innovate and develop products that enhance personalized healthcare and improve patient outcomes.
Key Features of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
Roche has established a strong portfolio in cancer immunohistochemistry, with various biomarkers that assist in cancer diagnosis and treatment decisions. The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is a qualitative immunohistochemical test using mouse monoclonal anti-FOLR1 clone FOLR1-2.1. It evaluates the folate receptor alpha (FRɑ) in formalin-fixed, paraffin-embedded tissue samples from EOC patients, including those with primary peritoneal cancer and fallopian tube cancer. The test employs the OptiView DAB IHC Detection Kit on a BenchMark ULTRA instrument.
The approval of this assay is based on results from the SORAYA6 and MIRASOL7 clinical studies. Both studies included platinum-resistant EOC patients who tested positive for FRɑ using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. In the SORAYA trial, 32% of participants displayed a partial or complete response to ELAHERE therapy.5 In the MIRASOL trial, patients receiving ELAHERE experienced significant improvements in progression-free survival and overall survival compared to those receiving chemotherapy, showing a 35% reduction in the risk of tumor progression or death (HR 0.65, 95% CI, 0.52-0.81) and a 33% reduction in the risk of death (HR 0.67, 95% CI, 0.50-0.89).7
About Roche
Founded in 1896 in Basel, Switzerland, Roche has become the world’s largest biotechnology company and a leader in in-vitro diagnostics. The company is dedicated to advancing scientific excellence, developing medicines and diagnostics to enhance and save lives globally. As a pioneer in personalized healthcare, Roche seeks to transform treatment through innovative solutions.
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Roche Achieves Milestone with CE Mark for Groundbreaking Ovarian Cancer Diagnostic
Roche’s commitment to transforming healthcare is evident as it combines diagnostics and pharmaceuticals with valuable clinical data to deliver optimized patient care.
For the fifteenth consecutive year, Roche has been recognized as one of the most sustainable companies in the pharmaceuticals sector by the Dow Jones Sustainability Indices. This accolade highlights the company’s long-term vision and dedication to improving healthcare access in collaboration with local partners globally.
Genentech, a fully owned subsidiary of Roche, operates in the United States. Additionally, Roche holds a majority stake in Chugai Pharmaceutical, which is based in Japan.
For further details about Roche’s initiatives, visit www.roche.com.
All trademarks mentioned in this release are legally protected.
References
1Scaranti, M., Cojocaru, E., Banerjee, S. et al. Exploiting the folate receptor α in oncology. Nat Rev Clin Oncol 17, 349–359 (2020).
2Hilgenbrink A., Low P. Folate receptor-mediated drug targeting: From Therapeutics to diagnostics. Journal of Pharmaceutical Sciences. 2005;94(10): 2135-2146.
3James, Racheal L., et al. “Development of an FRα Companion Diagnostic Immunohistochemical Assay for Mirvetuximab Soravtansine.” Archives of Pathology & Laboratory Medicine (2024).
4Roche. VENTANA FOLR1 (FOLR-2.1) RxDx Assay. CE Package Insert. 2024.
5Bray, Freddie, et al. “Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.” CA: a cancer journal for clinicians 74.3 (2024): 229-263.
6Matulonis, Ursula A., et al. “Efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression: results from the SORAYA study.” Journal of clinical oncology 41.13 (2023): 2436-2445.
7Moore, Kathleen N., et al. “Phase III MIRASOL (GOG 3045/ENGOT-Ov55) study: mirvetuximab soravtansine vs. investigator’s choice of chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.” J Clin Oncol 41 (2023): abstrLBA5507.
Roche Media Relations
Jo Lynn Garing
Phone: +1 317-363-7286
Email: jo_lynn.garing@roche.com
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