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Molecular Profile MSH6 negative
Therapy Pembrolizumab
Indication/Tumor Type biliary tract cancer
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
MSH6 negative biliary tract cancer sensitive Pembrolizumab Guideline Actionable Keytruda (pembrolizumab) is included in guidelines as second or late-line therapy for biliary tract cancer patients with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) who have not received first-line immunotherapy (PMID: 39864891; ESMO.org). detail... 39864891
MSH6 negative biliary tract cancer sensitive Pembrolizumab Guideline Actionable Keytruda (pembrolizumab) is included in the Pan-Asian Guidelines Adaptation (PAGA) for patients with mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) biliary tract cancer who have progressed on or are intolerant of non-immune checkpoint inhibitor therapies (PMID: 39232586; ESMO.org). detail... 39232586
MSH6 negative biliary tract cancer sensitive Pembrolizumab Phase II Actionable In a Phase II trial (KEYNOTE-158), Keytruda (pembrolizumab) treatment resulted in an objective response rate of 40.9% (9/22, 3 complete responses and 6 partial responses), a duration of response of 30.5 mo, a median progression-free survival of 4.2 mo, and a median overall survival of 19.4 mo in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) biliary tract cancer (PMID: 35680043; NCT02628067). 35680043
PubMed Id Reference Title Details
ESMO Clinical Practice Guidelines Full reference...
ESMO Clinical Practice Guidelines Full reference...
(35680043) Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study. Full reference...
(39232586) Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with biliary tract cancer. Full reference...
(39864891) ESMO Clinical Practice Guideline interim update on the management of biliary tract cancer. Full reference...