TAFINLAR (dabrafenib) + MEKINIST (trametinib) indications:1,2
Melanoma
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Adjuvant treatment of melanoma
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Non-small cell lung cancer (NSCLC)
Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer BRAF V600 mutation.
Durable Relapse-Free Survival at Five Years3
TAFINLAR (dabrafenib) and MEKINIST (trametinib) is the first targeted therapy to show DURABLE five-year relapse-free survival vs. placebo in adult BRAF V600-positive patients with completely resected Stage III melanoma3–5
Key Clinical Data Insights
The efficacy and safety of TAFINLAR + MEKINIST for the adjuvant treatment of adult patients with BRAF V600-positive completely resected Stage III melanoma has been studied in a large Phase III trial, COMBI-AD.6
Please visit the COMBI-AD safety page for further information on the TAFINLAR + MEKINIST safety profile in the adjuvant setting.
DURABLE relapse-free survival (RFS) at five years was seen in 52% of patients with TAFINLAR + MEKINIST and the reduced risk of relapse or death vs. placebo was 49%.3,4
The median RFS time for the TAFINLAR + MEKINIST arm was not reached at the cut-off due to a low event rate, whereas the median RFS time for the placebo arm (95% CI) was 16.6 months (12.7–22.1).3,4
The COMBI-AD trial showed that patients treated with TAFINLAR and MEKINIST had a 45% reduction in the risk of developing distant metastases or dying compared to placebo (five-year distant metastasis-free survival 65% vs. 54%).3,4
TAFINLAR + MEKINIST is the only oral adjuvant therapy with three-year overall survival data (86% of patients are alive at three years with treatment*). Final overall survival analysis will be performed when 299 overall survival events have occurred.3,6
COMBI-AD was a randomised, double-blind, placebo-controlled, Phase III trial that compared TAFINLAR + MEKINIST vs. placebo in adult patients with Stage III BRAF V600E/K-positive melanoma.6 The planned duration of treatment was 12 months.6
*The 3-year overall survival rate was 86% in the combination-therapy group and 77% in the placebo group (hazard ratio for death, 0.57; 95% CI, 0.42 to 0.79; P=0.0006), but this level of improvement did not cross the prespecified interim analysis boundary of P=0.000019.3
References
- TAFINLAR (dabrafenib). Summary of Product Characteristics.
- MEKINIST (trametinib). Summary of Product Characteristics.
- Dummer R, et al. N Engl J Med 2020; DOI: 10.1056/NEJMoa2005493.
- Hauschild A, et al. Presented at ASCO 2020 virtual congress, 29–31 May, Chicago, USA.
- Novartis. Novartis Tafinlar + Mekinist receives FDA approval for first tumor-agnostic indication for BRAF V600E solid tumors. Available at: https://www.novartis.com/news/media-releases/novartis-tafinlar-mekinist-... [Accessed March 2023].
- Long GV, et al. N Engl J Med 2017;377:1813–1823.
- Schadendorf D, et al. Presented at ASCO 2018;1–5 June, Chicago, USA.