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Molecular Profile Unknown unknown
Therapy Pembrolizumab
Indication/Tumor Type melanoma
Response Type not applicable

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown melanoma not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-002) that supported FDA approval, treatment with Keytruda (pembrolizumab) resulted in improved progression-free survival (PFS) compared to chemotherapy in patients with Yervoy (ipilimumab)-refractory melanoma, with a HR of 0.57 (p<0.0001) in the 2mg/kg group and a HR of 0.50 (p<0.0001) in the 10mg/kg group (PMID: 26115796; NCT01704287). detail... 26115796
Unknown unknown melanoma not applicable Pembrolizumab FDA approved Actionable In a Phase III trial (KEYNOTE-054) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in significantly improved recurrence-free survival rate at 1 year (75.4% vs 61.0%, HR=0.57, p<0.001) compared to placebo in patients with resected, high-risk stage III melanoma (PMID: 29658430; NCT02362594). 29658430 detail...
Unknown unknown melanoma not applicable Pembrolizumab FDA approved Actionable In a Phase III trial (KEYNOTE-006) that supported FDA approval, treatment with Keytruda (pembrolizumab) resulted in improved progression-free survival (PFS) and overall survival (OS) in patients with metastatic melanoma, with a 6-month PFS rate of 47.3% for the every 2 week schedule and 46.4% for the every 3 week schedule versus 26.5% with Yervoy (ipilimumab) (PMID: 25891173; NCT01866319). 25891173 detail...
Unknown unknown melanoma not applicable Pembrolizumab Clinical Study Actionable In a clinical study, analysis of three trials demonstrated no difference between objective response rate (ORR), 39.8% (447/1124) vs 34.3% (149/434), 4 year progression-free survival (PFS), 22.9% vs 19.8%, and overall survival, 37.5% vs 35.1%, in melanoma patients harboring wild-type BRAF vs BRAF V600E/K, and showed patients previously treated with a BRAF inhibitor w/ or w/o a MEK inhibitor had a lower ORR (28.4% vs 44.2%) and PFS (15.2% vs 27.8%) compared to patients who were not treated (PMID: 32672795). 32672795
PubMed Id Reference Title Details
(25891173) Pembrolizumab versus Ipilimumab in Advanced Melanoma. Full reference...
(26115796) Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Full reference...
(29658430) Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma. Full reference...
Keytruda (pembrolizumab) FDA Drug Label Full reference...
Keytruda (pembrolizumab) FDA Drug Label Full reference...
Keytruda (pembrolizumab) FDA Drug Label Full reference...
(32672795) Association of BRAF V600E/K Mutation Status and Prior BRAF/MEK Inhibition With Pembrolizumab Outcomes in Advanced Melanoma: Pooled Analysis of 3 Clinical Trials. Full reference...