- 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 test identifies ovarian cancer patients eligible for
targeted treatment with ELAHERE.
- This certification follows the unprecedented decision by
regulators to grant an early exemption approval for the test in
Germany and Austria earlier this year.
TUCSON,
Ariz., Nov. 18, 2024 /PRNewswire/ -- Roche (SIX:
RO, ROG; OTCQX: RHHBY) announced today that it has received CE Mark
for its VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay. This is the first
immunohistochemistry (IHC) companion diagnostic test to be made
widely available in Europe to aid
in identifying epithelial ovarian cancer (EOC) patients who may be
eligible for targeted treatment with ELAHERE® (mirvetuximab
soravtansine). ELAHERE is a first-in-class antibody-drug conjugate
(ADC) therapy developed by AbbVie for the treatment of FRɑ-positive
platinum-resistant ovarian cancer.
This certification follows the news earlier this year that the
VENTANA FOLR1 (FOLR1-2.1) test had received pre-authorisation in
Germany and Austria. This exceptional decision allowed
clinicians and patients in these countries to access the test ahead
of the CE Mark certification.
"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."
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 VENTANA
FOLR-1 (FOLR1-2.1) 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.
Ovarian cancer is the eighth overall cause for cancer death in
women worldwide, representing 4.7% of all cancer deaths in women.
It is also one of the deadliest gynaecological cancers worldwide.
In 2022, 46,232 women in Europe
and 209,596 women worldwide died from ovarian
cancer.5
The launch of Roche's first IHC companion test for ovarian
cancer in CE countries 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.
About the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
Roche
has developed a leading, comprehensive and differentiated cancer
immunohistochemical portfolio, with biomarkers that support
multiple guidelines for the diagnosis and stratification of
cancers. VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is a qualitative
immunohistochemical assay using mouse monoclonal anti-FOLR1 clone
FOLR1-2.1 intended for use in the assessment of folate receptor
alpha (FRɑ) in formalin-fixed, paraffin-embedded epithelial ovarian
cancer (EOC), including primary peritoneal cancer and primary
fallopian tube cancer, tissue specimens by light microscopy. The
OptiView DAB IHC Detection Kit is used for staining on a BenchMark
ULTRA instrument.
The approval is based on the results from the SORAYA6
and MIRASOL7 clinical studies. Both studies enrolled
platinum-resistant epithelial ovarian cancer patients who were
FRɑ-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.5 In the MIRASOL
trial, patients who received ELAHERE demonstrated a significant
improvement in progression-free survival by investigator assessment
compared with IC chemotherapy, which represented a 35% reduction in
the risk of tumour 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, which represented 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, as one of the first industrial manufacturers of
branded medicines, Roche has grown into the world's largest
biotechnology company and the global leader in in-vitro
diagnostics. The company pursues scientific excellence to discover
and develop medicines and diagnostics for improving and saving the
lives of people around the world. We are a pioneer in personalised
healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care
for each person we partner with many stakeholders and combine our
strengths in Diagnostics and Pharma with data insights from the
clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United
States, is a wholly owned member of the Roche Group. Roche
is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
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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