On August 11, 2022 Roche (SIX: RO, ROG;OTCQX: RHHBY) reported US Food and Drug Administration (FDA) approval of a label expansion for the VENTANA MMR RxDx Panel (Press release, Hoffmann-La Roche, AUG 11, 2022, View Source [SID1234618185]). 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 .
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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
About the VENTANA MMR RxDx Panel
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.
About KEYTRUDA in MSI-H or dMMR cancer in solid tumours
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.
About KEYTRUDA in endometrial carcinoma
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.