Profile Response Detail

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
MLH1 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
MLH1 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...
(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...