Roche receives FDA approval for VENTANA MMR RxDx Panel to identify dMMR solid tumour patients and pMMR endometrial cancer patients eligible for KEYTRUDA

• Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps identify solid tumour patients, including endometrial cancer patients, for treatment with Merck's immunotherapy KEYTRUDA.
• The test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians.
• Merck collaboration builds on Roche's commitment to enable personalised healthcare strategies for patients.

TUCSON, Ariz., Aug. 11, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of a label expansion for the VENTANA MMR RxDx Panel. This approval advances the company's commitment to personalised healthcare through tests that determine which patients are most likely to respond to specific and targeted therapies.

The VENTANA MMR RxDx Panel is the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (dMMR), and who may be eligible for KEYTRUDA^® (pembrolizumab). The panel is also the first companion diagnostic test to aid in identifying endometrial cancer patients whose tumours are proficient in DNA mismatch repair (pMMR), and who may be eligible for a combination of KEYTRUDA and the tyrosine kinase inhibitor (TKI) LENVIMA^® (lenvatinib). The test evaluates a panel of MMR proteins in tumours to provide important treatment information to clinicians.

"Roche is committed to advancing personalised healthcare options for all solid tumour patients," said Jill German, Head of Pathology, Roche Diagnostics. "As the first companion diagnostic of its kind, our test provides patients with access to multiple therapies, enabling targeted treatment. We are pleased that our innovative companion diagnostic portfolio continues to grow to serve more patients."

MMR is a naturally occurring mechanism that scans our DNA, correcting errors that cause disease. When MMR is deficient (dMMR), 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, cervical and neuroendocrine cancers. In the US, prevalence of dMMR across patients with solid tumours has been estimated at 14 percent.¹ PD-1 inhibitors can be an effective treatment in cancers with MMR deficiency. For endometrial cancer patients without this MMR deficiency (pMMR) PD-1 inhibitors may retain activity when combined with a tyrosine kinase inhibitor (TKI).

FDA approval of the label expansion for the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated panel of MMR biomarkers tested by IHC. This label expansion follows the April 2021 FDA approval of the VENTANA MMR RxDx Panel as the first IHC predictive test to identify endometrial carcinoma patients eligible for treatment with the anti-PD1 immunotherapy JEMPERLI^® (dostarlimab-gxly). That approval was expanded for the following indications on the dates below:

• August 2021 - dMMR solid tumour patients for treatment with JEMPERLI
• March 2022 - dMMR solid tumour patients for treatment with KEYTRUDA
• June 2022 - pMMR solid tumour patients for treatment with a combination of KEYTRUDA and LENVIMA

Cancer is the second leading cause of death worldwide, with nearly 10 million deaths annually.^{2, 3} Endometrial cancer is the most common gynaecological cancer in the U.S. and the fourth most common cancer in women in North America.⁴

This 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.

DNA mismatch repair (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.^5,6,7 PD-1 inhibitors can be effective in cancers with MMR deficiency.^5,7 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. Read more about Roche's innovation in MMR biomarker testing.

In May 2017, KEYTRUDA became the first cancer treatment approved by the U.S. Food and Drug Administration for a tissue-agnostic indication.⁸ The FDA granted accelerated approval to KEYTRUDA for the treatment of adult and paediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient solid tumours, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Subsequently, KEYTRUDA was approved by the FDA in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation and as a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Founded in1896 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 thirteenth 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. Merck is known as Merck Sharp & Dohme (MSD) outside the U.S. and Canada. KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

[1] Lortet-Tieulent J, et al. J Natl Cancer Inst. 110, 354-361.
[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] Siegel RL, Miller KD, et al. CA Cancer J Clin. 2019:69(1):7-34.
[5] Lee YC, S Lheureux, et al. Curr Opin Obstet Gynecol. 2017:29:47-58.
[6] 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.
[7] 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.
[8] U.S. Food and Drug Administration. FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication. [Internet; cited 20 July 2022.] Available from: FDA.gov.

For further information please contact:

Jo Lynn Garing, Roche Diagnostics Communications
Mobile: +1 317-508-6337
E-mail: [email protected] 

SOURCE Roche