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