Key clinical-trial evidence for trametinib

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK), 2013.

Introduction

On May 29, 2013, the U. S. Food and Drug Administration (FDA) approved trametinib (MEKINIST™ tablets, GlaxoSmithKline, USA), as a single agent oral treatment for patients with non-operable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations as detected by an FDA-approved test, called the THxID™ – BRAF assay from bioMérieux S.A.

Trametinib is the fourth new cancer drug approved that demonstrates an improvement in overall survival in melanoma patients.

It is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy such as dabrafenib or vemurafenib.

Clinical trial evidence for trametinib

FDA approval was based on results of the phase III METRIC trial.

METRIC trial highlights

The most common adverse reactions (greater than or equal to 10%) of any grade in patients receiving trametinib included:

Key efficacy findings are summarised in the tables below.

Table 1
Efficacy parameterTrematinib (n = 214)Chemotherapy (n = 108)
Median progression-free survival (months) 4.8 (95% confidence interval [CI]: 4.3, 4.9) 1.5 (95% CI: 1.4, 2.7)
Overall tumour response rates (% patients) 22% (95% CI: 17, 28) 8% (95% CI: 4, 15)
Complete response, n (%) 4 (2%) 0
Partial response, n (%) 43 (20%) 9 (8%)
Median duration of response (months) 5.5 (95% CI: 4.1, 5.9) Not reached
Table 2
Adverse Reactions
(no. patients)
Trematinib (N = 211)Chemotherapy (N = 99)
All Grades Grades 3 and 4 All Grades Grades 3 and 4
Skin and subcutaneous tissue disorders
Rash 57 8 10 0
Dermatitis acneiform 19 <1 1 0
Dry skin 11 0 0 0
Pruritus 10 2 1 0
Paronychia 10 0 1 0
Gastrointestinal disorders
Diarrhoea 43 0 16 2
Stomatitis 15 2 2 0
Abdominal pain 13 1 5 1
Vascular disorders
Lymphoedema 32 1 4 0
Hypertension 15 12 7 3
Haemorrhage 13 <1 0 0

Clinical trial evidence on the efficacy of combined dabrafenib and trematinib

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