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Ref Type
PMID
Authors
Title Jemperli (Dostarlimab-gxly) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761174
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Dostarlimab-gxly Dostarlimab-gxly 50 27
Drug Name Trade Name Synonyms Drug Classes Drug Description
Dostarlimab-gxly Jemperli Dostarlimab|TSR-042 Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 139 Jemperli (dostarlimab-gxly) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (PMID: 34313545). Jemperli (dostarlimab-gxly) is FDA approved for use in patients with recurrent or advanced endometrial cancer or solid tumors harboring mismatch repair deficiency (dMMR), as determined by an FDA-approved test, who have progressed on prior treatments, in combination with Paraplatin (carboplatin) and Taxol (paclitaxel), followed by Jemperli (dostarlimab-gxly) monotherapy, in patients with primary advanced or recurrent endometrial cancer, and in patients with Stage II/III locally advanced rectal cancer that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
MSH6 negative endometrial cancer sensitive Dostarlimab-gxly FDA approved - On Companion Diagnostic Actionable In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 42.3% (30/71, 9 complete responses, 21 partial responses), with a median duration of response not reached in patients with recurrent or advanced endometrial cancer harboring mismatch repair deficiency (dMMR) as confirmed by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (PMID: 33001143; NCT02715284). detail... 33001143 detail...
MLH1 negative endometrial cancer sensitive Dostarlimab-gxly FDA approved - On Companion Diagnostic Actionable In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 42.3% (30/71, 9 complete responses, 21 partial responses), with a median duration of response not reached in patients with recurrent or advanced endometrial cancer harboring mismatch repair deficiency (dMMR) as confirmed by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (PMID: 33001143; NCT02715284). detail... 33001143 detail...
MSH6 negative rectum cancer sensitive Dostarlimab-gxly FDA approved - On Companion Diagnostic Actionable In a Phase II trial (AZUR-1) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment resulted in a composite rate of clinical complete response for 12 months (cCR12) of 68% in patients (n=144) with previously untreated microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) stage II/III locally advanced rectal cancer, with 76% of patients achieved cCR12 and CR (PMID: 42927858; NCT05723562). detail... detail... 42927858
MSH6 negative Advanced Solid Tumor sensitive Dostarlimab-gxly FDA approved - On Companion Diagnostic Actionable In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 44.0% (144/327), with a median progression-free survival of 7.0 mo, and median overall survival and duration of response not reached in patients with advanced mismatch repair deficient (dMMR) solid tumors, as indicated by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (PMID: 37917058; NCT02715284). detail... detail... 37917058
MLH1 negative rectum cancer sensitive Dostarlimab-gxly FDA approved - On Companion Diagnostic Actionable In a Phase II trial (AZUR-1) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment resulted in a composite rate of clinical complete response for 12 months (cCR12) of 68% in patients (n=144) with previously untreated microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) stage II/III locally advanced rectal cancer, with 76% of patients achieved cCR12 and CR (PMID: 42927858; NCT05723562). detail... 42927858 detail...
MLH1 negative Advanced Solid Tumor sensitive Dostarlimab-gxly FDA approved - On Companion Diagnostic Actionable In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 44.0% (144/327), with a median progression-free survival of 7.0 mo, and median overall survival and duration of response not reached in patients with advanced mismatch repair deficient (dMMR) solid tumors, as indicated by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (PMID: 37917058; NCT02715284). 37917058 detail... detail...