Roche's VENTANA MMR RxDx Panel companion diagnostic receives IVDR approval across multiple cancer types and therapies

• Used as a predictive biomarker, the first-of-its-kind VENTANA MMR RxDx Panel helps identify cancer patients eligible for treatment with certain precision oncology therapies
• By evaluating a panel of MMR proteins in tumours, the test provides clinicians with a standardised testing option to determine mismatch repair (MMR) status
• This IVDR approval expands the companion diagnostic's label to include five cancer types and six indications

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the European Union In Vitro Diagnostic Regulation (IVDR) approval of several label expansions for the VENTANA® MMR RxDx Panel, an immunohistochemistry (IHC) companion diagnostic test that aids in identifying a cancer patient's mismatch repair (MMR) status. MMR is a process that scans a person's genetic code and fixes errors to prevent mutations that can lead to cancer. The test evaluates a panel of MMR proteins in tumours to provide this important treatment information to clinicians.

"By providing a standardised testing option for mismatch repair status with our VENTANA MMR RxDx Panel, we are empowering clinicians to make more informed decisions and expanding access to important therapies for patients across multiple solid tumor types," said Laura Apitz, Head of Pathology Lab at Roche Diagnostics. "This milestone exemplifies our dedication to delivering high-medical-value solutions that help improve patient outcomes through precision medicine."

The VENTANA MMR RxDx Panel is now available in countries regulated by IVDR as a companion diagnostic for the following therapies and cancer types:

• KEYTRUDA^® (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA's anti-PD-1 therapy: For the treatment of mismatch repair deficient (dMMR) tumors in certain adults with: metastatic colorectal cancer; advanced or recurrent endometrial carcinoma; unresectable or metastatic gastric, small intestine or biliary cancer.
• IMFINZI^® (durvalumab), AstraZeneca's anti-PD-L1 therapy: For adult patients with dMMR primary advanced or recurrent endometrial cancer.
• IMFINZI^® + LYNPARZA^® (olaparib), AstraZeneca's anti-PD-L1 therapy and PARP inhibitor: For adult patients with mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.
• JEMPERLI^® (dostarlimab-gxly), GSK's anti-PD-1 therapy: for dMMR patients with endometrial cancer.¹

About MMR
Cancer remains the second leading cause of death worldwide, resulting in nearly 10 million deaths annually.^{2, 3} Identifying specific biomarkers is critical to help identify patients who are eligible for certain therapies, as dMMR serves as a vital predictive biomarker for modern immunotherapies.

MMR is a naturally occurring mechanism that scans our DNA, correcting errors that cause disease. When MMR is deficient, cells mutate, which can lead to cancer. While MMR deficiency is most common in endometrial cancer, other high-prevalence dMMR tumour types include gastric, colorectal, small intestine and biliary tract cancers. Because dMMR tumours often have a high mutational burden they may respond well to immune checkpoint inhibitors (ICIs) such as PD-1 or PD-L1 inhibitors. For patients with endometrial cancer without MMR deficiency (pMMR), the addition of PARP inhibitors in maintenance to ICIs may further enhance the benefit of ICIs. PD-1 inhibitors may retain activity when combined with a tyrosine kinase inhibitor (TKI).

About the VENTANA MMR RxDx Panel
This IVDR approval for the VENTANA MMR RxDx Panel is a label expansion of Roche's current on-market panel. The VENTANA MMR RxDx Panel is intended for the assessment of expression of MMR proteins in formalin-fixed, paraffin-embedded (FFPE) tumour tissue stained with OptiView DAB IHC Detection Kit and ancillary reagents in the panel for VENTANA anti-MLH1 (M1), VENTANA anti-MSH2 (G219-1129) and VENTANA anti-MSH6 (SP93), and OptiView DAB IHC Detection Kit with the OptiView Amplification Kit and ancillary reagents for VENTANA anti-PMS2 (A16-4) on a BenchMark ULTRA instrument.

MMR proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.^4,5,6 PD-1 inhibitors can be effective in cancers with MMR deficiency.^4,6 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins. 

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.
KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

References
[1] Jemperli EU label Jemperli, INN-Dostarlimab
[2] Journal of Oncology. [Internet; cited 20 July 2022.] Available from: doi.org/10.1155/2020/1807929.
[3] Siegel RL, Miller KD, et al. CA Cancer J Clin. 2020:70(1):7-30.
[4] Lee YC, S Lheureux, et al. Curr Opin Obstet Gynecol. 2017:29:47-58.
[5] Merck. European Commission Approves KEYTRUDA^® (pembrolizumab) as First-Line Treatment in Adult Patients With Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer [Internet; cited 20 July 2022.] Available from: Merck.com.
[6] Kato M, Takano M, Miyamoto M, et al. DNA mismatch repair-related protein loss as a prognostic factor in endometrial cancers. J Gynecol Oncol. 2015:26(1):40-45.

Roche Media Relations
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