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Ref Type Journal Article
PMID (30787022)
Authors Marcus L, Lemery SJ, Keegan P, Pazdur R
Title FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors.
Journal Clinical cancer research : an official journal of the American Association for Cancer Research
Vol 25
Issue 13
Date 2019 07 01
URL
Abstract Text The FDA approved pembrolizumab on May 23, 2017, for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H), or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and for the treatment of unresectable or metastatic MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The FDA granted the approval based on an understanding of the biology of MSI-H/dMMR across different tumors along with the clinically important effects on overall response rate (ORR) observed in patients who were enrolled in 1 of 5 single-arm clinical trials. The ORR was 39.6% among 149 patients with 15 different tumor types (95% confidence interval, 31.7-47.9), with a 7% complete response rate. The duration of response ranged from 1.6+ months to 22.7+ months, with 78% of responses lasting ≥6 months. Overall, the adverse event profile of pembrolizumab was similar to the adverse event profile observed across prior trials that supported the approval of pembrolizumab in other indications. This approval of pembrolizumab is the first time that the FDA has approved a cancer treatment for an indication based on a common biomarker rather than the primary site of origin.

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Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
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
MLH1 negative Advanced Solid Tumor sensitive Pembrolizumab FDA approved Actionable In a combined analysis of 5 trials that supported FDA approval, Keytruda (pembrolizumab) therapy resulted in an objective response rate of 39.6% (59/149) in advanced solid tumor patients with high levels of microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (PMID: 30787022; NCT01876511, NCT02460198, NCT01848834, NCT02054806, NCT02628067). detail... 30787022
MSH6 negative Advanced Solid Tumor sensitive Pembrolizumab FDA approved Actionable In a combined analysis of 5 trials that supported FDA approval, Keytruda (pembrolizumab) therapy resulted in an objective response rate of 39.6% (59/149) in advanced solid tumor patients with high levels of microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (PMID: 30787022; NCT01876511, NCT02460198, NCT01848834, NCT02054806, NCT02628067). detail... 30787022