^
Association details:
| Biomarker: | BRAF V600K |
|---|---|
| Cancer: | Cutaneous Melanoma |
| Drug: | Mekinist (trametinib) (MEK inhibitor) + Tafinlar (dabrafenib) (BRAF inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
03/31/2020
Excerpt:
Recommendation 2.3….For patients with resected stage IIIA/B/C/D BRAF-mutant (V600E/K*) disease, the following therapy options should be offered (in no particular order)…dabrafenib plus trametinib…52 weeks.
DOI:
10.1200/JCO.20.00198
Source:
Title:
COMBI-d: A randomized, double-blinded, Phase III study comparing the combination of dabrafenib and trametinib to dabrafenib and trametinib placebo as first-line therapy in patients (pts) with unresectable or metastatic BRAFV600E/K mutation-positive cutaneous melanoma
Excerpt:
Pts were randomized 1:1 to receive D (150 mg twice daily) + T (2 mg once daily) or D+ placebo (P) as first-line therapy….Eligible pts were ≥18 years and ECOG performance status ≤1, with histologically confirmed unresectable stage IIIC or IV, BRAFV600E/K mutant cutaneous melanoma....PFS was 0.75 (95% CI: 0.57, 0.99; p=0.035), in favor of D+T with a median PFS of 9.3 v 8.8 mo with D+P. The confirmed ORR was 67%(complete response [CR] 10%) for D+T and 51% (CR 9%) for D+P (p=0.0015). HR for interim OS was 0.63 (95% CI 0.42, 0.94; p=0.023), in favor of D+T (40 v 55 deaths)....D+T demonstrated a significant improvement in PFS compared to D+P in pts with BRAFV600E/K mutant MM.
DOI:
10.1200/jco.2014.32.15_suppl.9011
Trial ID:
Excerpt:
TAFINLAR is indicated, in combination with trametinib, for...the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
Source:
Title:
A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
Excerpt:
...Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive using the bioMerieux (bMx) investigational use only (IUO) THxID BRAF Assay (IDE: G120011). The assay will be conducted by a central reference laboratory. Subjects with ocular or mucosal melanoma are not eligible....
Trial ID:
