Roche has announced 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.
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), anti-PD-1 therapy: for the treatment of mismatch repair deficient (dMMR) tumours 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.
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).
