Therapy Detail

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Therapy Name Dabrafenib + Spartalizumab + Trametinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Dabrafenib Tafinlar GSK2118436 BRAF Inhibitor 25 Tafinlar (dabrafenib) inhibits the activity of BRAF, including V600E, which results in the inhibition of tumor cell proliferation (PMID: 22735384). Tafinlar (dabrafenib) is FDA approved for BRAF V600E/K- positive unresectable or metastatic melanoma, and in combination with Mekinist (trametinib) for BRAF V600E/K-mutant melanoma, BRAF V600E-mutant non-small cell lung cancer, BRAF V600E-mutant anaplastic thyroid cancer, for adult and pediatric patients of 6 years or older with unresectable or metastatic solid tumors harboring BRAF V600E, and for pediatric patients of 1 year or older with low-grade glioma harboring BRAF V600E (FDA.gov).
Spartalizumab PDR001|PDR-001 Immune Checkpoint Inhibitor 147 PD-L1/PD-1 antibody 117 Spartalizumab (PDR001) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (PMID: 32364844, PMID: 32179633).
Trametinib Mekinist GSK1120212 MEK inhibitor (Pan) 24 MEK1 Inhibitor 26 MEK2 Inhibitor 24 Mekinist (trametinib) inhibits MEK 1 and 2, which potentially leads to reduced tumor cell proliferation (PMID: 27956260). Mekinist (trametinib) is FDA approved for melanoma patients harboring BRAF V600E or BRAF V600K mutations, and in combination with Tafinlar (dabrafenib) for BRAF V600E/K-mutant melanoma, BRAF V600E- mutant non-small cell lung cancer, BRAF V600E-mutant anaplastic thyroid cancer, for adult and pediatric patients of 6 years or older with unresectable or metastatic solid tumors harboring BRAF V600E, and for pediatric patients of 1 year or older with low-grade glioma harboring BRAF V600E (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600X melanoma predicted - sensitive Dabrafenib + Spartalizumab + Trametinib Phase III Actionable In a Phase III trial (COMBI-i), the combination of Tafinlar (dabrafenib), Mekinist (trametinib), and Spartalizumab (PDR001) resulted in an objective response rate of 78% (28/36, 16 complete, 12 partial), disease control rate of 94% (34/36), and median progression-free survival of 23 months in patients with BRAF V600-mutant metastatic melanoma, including 29 patients (81%) harboring BRAF V600E and 4 patients (11%) harboring BRAF V600K (PMID: 33020648; NCT02967692). 33020648
BRAF V600E colorectal cancer sensitive Dabrafenib + Spartalizumab + Trametinib Phase II Actionable In a Phase II trial, the combination of Spartalizumab (PDR001), Tafinlar (dabrafenib), and Mekinist (trametinib) was well tolerated and resulted in a confirmed objective response rate of 24.3% (9/37, 2 complete responses), disease control rate of 70.3% (26/37), median progression-free survival of 4.3 months, median duration of response of 7.4 months, and median overall survival of 13.6 months in patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 36702949; NCT03668431). 36702949

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04310397 Phase II Dabrafenib + Trametinib Dabrafenib + Spartalizumab + Trametinib Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma Completed USA 0
NCT03668431 Phase II Dabrafenib + Spartalizumab + Trametinib Dabrafenib + Trametinib + PDR001 In Colorectal Cancer Recruiting USA 0
NCT02967692 Phase III Dabrafenib + Spartalizumab + Trametinib Dabrafenib + Trametinib A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma (COMBI-i) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 18


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