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Molecular Profile MLH1 negative
Therapy Dostarlimab-gxly
Indication/Tumor Type endometrial cancer
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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...
MLH1 negative endometrial cancer sensitive Dostarlimab-gxly Guideline Actionable Jemperli (dostarlimab-gxly) is included in the Pan-Asian Guidelines Adaptation (PAGA) for patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent or advanced endometrial cancer who have failed prior platinum-based chemotherapy (PMID: 36696825; ESMO.org). 36696825 detail...
MLH1 negative endometrial cancer sensitive Dostarlimab-gxly Guideline Actionable Jemperli (dostarlimab-gxly) is included in guidelines for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial cancer who have failed platinum-based therapy (PMID: 35690222; ESMO.org). 35690222 detail...
PubMed Id Reference Title Details
ESMO Clinical Practice Guidelines Full reference...
ESMO Clinical Practice Guidelines Full reference...
Full reference...
Jemperli (Dostarlimab-gxly) FDA Drug Label Full reference...
(33001143) Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial. Full reference...
(35690222) Endometrial cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Full reference...
(36696825) Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with endometrial cancer. Full reference...