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|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|BRAF V600E||low grade glioma||sensitive||Dabrafenib + Trametinib||Phase II||Actionable||In a Phase II trial (ROAR), Tafinlar (dabrafenib) and Mekinist (trametinib) combination treatment resulted in an objective response rate of 69% (9/13, 1 complete response, 6 partial responses, 2 minor responses) in patients with low-grade glioma harboring BRAF V600E, with median duration of response, median progression-free survival, and overall survival time unreached (PMID: 34838156; NCT02034110).||34838156|
|BRAF V600E||low grade glioma||sensitive||Dabrafenib + Trametinib||FDA approved||Actionable||In a Phase II trial that supported FDA approval, Mekinist (trametinib) plus Tafinlar (dabrafenib) significantly improved objective response rate (47% vs 11%, p<0.001, OR 7.2), clinical benefit rate (86% vs 46%), median progression-free survival (PFS, 20.1 vs 7.4 months, p<0.001, HR 0.31), and 12-month PFS rate (67% vs 26%) compared to chemotherapy in pediatric patients of 1 year and older with low-grade glioma harboring BRAF V600E (J Clin Oncol 40, no. 17_suppl (June 10, 2022) LBA2002; NCT02684058).||detail... detail... detail...|
|BRAF V600E||low grade glioma||sensitive||Dabrafenib + Trametinib||Guideline||Actionable||Combination of Mekinist (trametinib) and Tafinlar (dabrafenib) is included in guidelines for patients with recurrent or progressive low grade glioma harboring BRAF V600E (NCCN.org).||detail...|
|BRAF V600E||low grade glioma||sensitive||Dabrafenib + Trametinib||Phase Ib/II||Actionable||In a Phase I/II trial (Study X2101), Tafinlar (dabrafenib) and Mekinist (trametinib) combination treatment demonstrated manageable toxicity and resulted in an objective response rate of 25% (9/36, 1 complete response, 8 partial responses) and stable disease in 67% (24/36) of pediatric patients with pretreated low-grade glioma harboring BRAF V600E (J Clin Oncol 38, no. 15_suppl (May 20, 2020) 10506; NCT02124772).||detail...|
|PubMed Id||Reference Title||Details|
|Mekinist (trametinib) FDA Drug Label||Full reference...|
|Tafinlar (dabrafenib) FDA Drug Label||Full reference...|
|(34838156)||Dabrafenib plus trametinib in patients with BRAFV600E-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial.||Full reference...|
|Dabrafenib + trametinib combination therapy in pediatric patients with BRAF V600-mutant low-grade glioma: Safety and efficacy results.||Full reference...|
|Primary analysis of a phase II trial of dabrafenib plus trametinib (dab + tram) in BRAF V600–mutant pediatric low-grade glioma (pLGG).||Full reference...|