First PD-1 Therapy Approved for Endometrial Cancer with Companion MMR Diagnostic Test

On April 22, 2021, the U.S. FDA granted accelerated approval to GlaxoSmithKline’s dostarlimab-gxly (Jemperli) for the treatment of adult patients with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer, making JEMPERLI the first PD-1 therapy approved for endometrial cancer; notably, thisRocheVentana MMR RxDx PanelAsThe companion diagnostic reagent was also approved for use in screening patients most suitable for medication,This is the first FDA-approved companion diagnostic based on MMR biomarkers.。

Recently performed last monthInventory | FDA-Approved Companion Diagnostic Products as of March 2021, another immunotherapy-related biomarker is added to the list.Meanwhile, recent advances in MSI, which is closely associated with MMR, in the field of companion diagnostics also corroborate that immunotherapy isEntering a More Precise Era, see detailsCompanion Diagnostics | Biocartis Submits to FDA: First MSI Companion Diagnostic Kit Is Worth Anticipating 。

The list of companion diagnostic tests on the FDA website has been updated as follows:

From the perspective of clinical indications, the Ventana MMR RxDx Panel is alsoFirstInEndometrial CancerPatient AssessmentEligibility for PD-1 ImmunotherapyCompanion Diagnostic Reagents.Endometrial cancer is the most common gynecologic cancer in the United States and the fourth most common cancer among women in North America.In China, the incidence of endometrial cancer is also rising year by year, and in Beijing, Shanghai, and Guangzhou, it has even surpassed cervical cancer to become the most common malignant tumor of the female reproductive system. Globally,Approximately 90,000 women die annually from endometrial cancer or after first-line treatment.

Thomas Schinecker, CEO of Roche Diagnostics, stated, “We are pleased to collaborate with GSK on this companion diagnostic test to help patients with recurrent or advanced endometrial cancer who have limited treatment options.” “This test provides clinicians with an effective tool to identify the patients most suitable for GSK’s JEMPERLI immunotherapy, offering new treatment options for women with mismatch repair-deficient (MMRd) endometrial cancer.”

Ventana MMR RxDx PanelProvides clinicians with standardized, fully automated MMR testing, leveragingImmunohistochemistry (IHC)Methods for Four MMR Marker Proteins：MLH1, PMS2, MSH2, and MSH6, conduct comprehensive testing。

About MMR

MMR is a molecular mechanism., if the expression of any MMR protein is lost (dMMR), it can cause defects in the cell's mismatch repair function, resulting in the loss of ability to repair base mismatches during DNA replication. If the expression of any one of the four MMR proteins is absent (negative), the tumor is classified asdMMR; if all four proteins are positive, the tumor ispMMR。

As outlined in the article “Inventory,” the assessment of benefit from immunotherapy drugs can be conducted, on one hand, by directly detecting PD-L1 expression and, on the other hand, by analyzing the genomic signature of the tumor microenvironment—namely, the interrelated and intertwined markers MMR, MSI, and TMB. Studies have shown thatThe absence of expression of one or more MMR proteins may indicate an increased likelihood of benefiting from immunotherapy.JEMPERLI monotherapy isAnti-PD-1 Immunotherapy,MMR TestingPatients eligible for JEMPERLI monotherapy can be assessed.。