Duration of response | TAFINLAR® (dabrafenib) + MEKINIST® (trametinib)

_{^{For Healthcare Professionals Outside the US}}
_{^{Tafinlar + Mekinist is indicated for adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection; for first-line treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation; for adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.}}

It looks like you are using an older version of Internet Explorer which is not supported. We advise that you update your browser to the latest version of Microsoft Edge, or consider using other browsers such as Chrome, Firefox or Safari.

Home > Efficacy > Metastatic BRAF V600+ Melanoma > Duration of response

For first-line targeted therapy in patients with BRAF V600 positive metastatic melanoma

First-line TAFINLAR + MEKINIST demonstrated durable responses, with a median duration of response of 39.6 months in patients who achieved a CR in the COMBI-v trial¹

TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) duration of response

The majority of patients (53%) who achieved a CR on first-line TAFINLAR + MEKINIST remained in CR after a median follow-up of 23 months in the COMBI-v study¹

In the 2 phase 3 studies, TAFINLAR + MEKINIST demonstrated durable responses, with median durations of response ranging from 12.9 to 13.8 months^1,2

Duration of response phase 3 studies TAFINLAR® (dabrafenib) + MEKINIST® (trametinib)

In COMBI-v, the median duration of response with TAFINLAR + MEKINIST was 13.8 months compared with 7.9 months with vemurafenib¹
In COMBI-d, the median duration of response with TAFINLAR + MEKINIST was 12.9 months compared with 10.6 months with TAFINLAR monotherapy²

CR, complete response.

References: 1. Robert C, Karaszewska B, Schachter J, et al. Three-year estimate of overall survival in COMBI-v, a randomized phase 3 study evaluating first-line dabrafenib + trametinib in patients with unresectable or metastatic BRAF V600E/K-mutant cutaneous melanoma. Presented at: European Society for Medical Oncology; October 7-11, 2016; Copenhagen, Denmark. 2. Long GV, Stroyakovskiy D, Gogas H, et al. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015;386(9992):444-451.

COVID-19 Update

Novartis is closely monitoring the evolving COVID-19 pandemic. For the most recent information on how Novartis is responding, visit the COVID-19 Information Center.

During this time of uncertainty it is important to communicate with your patients about COVID-19 to clarify that they should not stop their treatments except under the direction of the treating physician, and to ensure that patients have sufficient drug to avoid any treatment interruptions.

Reach out to your Novartis representative with any questions related to Novartis products.

04/20 G-ONC-1230566

COMBI-AD was a double-blind, placebo-controlled, Phase 3 trial that compared Tafinlar + Mekinist vs placebo⁴

ELIGIBILITY REQUIREMENTS

Resection of histologically confirmed Stage IIIA, B, or C with BRAF V600E or BRAF V600K mutation
ECOG performance status ≤1
No prior systemic anticancer treatment or radiotherapy for melanoma

TAFINLAR 150 mg BID + MEKINIST
2 mg QD (n=438)

imgh22

Placebo (n=432)

STUDY ENDPOINTS

Primary endpoint was RFS
Secondary endpoints were OS, distant metastasis-free survival, freedom from relapse, and safety

COMBI-d phase 3 study: Tafinlar® (dabrafenib) + Mekinist® (trametinib) vs Tafinlar® monotherapy