^
Association details:
| Biomarker: | BRAF V600K |
|---|---|
| Cancer: | Melanoma |
| Drug: | Mekinist (trametinib) (MEK inhibitor) + Tafinlar (dabrafenib) (BRAF inhibitor) + spartalizumab (PDR001) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Spartalizumab or placebo in combination with dabrafenib and trametinib in patients with BRAF V600-mutant melanoma: exploratory biomarker analyses from a randomized phase 3 trial (COMBI-i)
Published date:
06/21/2022
Excerpt:
In COMBI-i (ClinicalTrials.gov, NCT02967692), 532 patients received spartalizumab 400 mg intravenously every 4 weeks plus dabrafenib 150 mg orally two times daily and trametinib 2 mg orally one time daily or placebo-DabTram....Subgroups defined by BRAF V600K mutation (HR 0.45 (95% CI 0.21 to 0.99)), detectable ctDNA shedding (HR 0.75 (95% CI 0.58 to 0.96)), or CD4+/CD8+ ratio above median (HR 0.58 (95% CI 0.40 to 0.84)) derived greater PFS benefit with sparta-DabTram vs placebo-DabTram....These results support the feasibility of large-scale comprehensive biomarker analyses in the context of a global phase 3 study.
DOI:
10.1136/jitc-2021-004226
Trial ID:
