Efficacy of TAFINLAR® (dabrafenib) + MEKINIST® (trametinib)
TAFINLAR in combination with MEKINIST is indicated in adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.1,2
TAFINLAR in combination with MEKINIST is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.1,2
Common adverse events include:
TAFINLAR + MEKINIST: The most common adverse reactions (incidence ≥20%) for dabrafenib in combination with trametinib were pyrexia, fatigue, nausea, chills, headache, diarrhoea, vomiting, arthralgia and rash1,2
TAFINLAR: The most common adverse reactions (incidence >15%) reported with dabrafenib were hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, papilloma, alopecia, rash and vomiting1
MEKINIST: The most common adverse reactions (incidence ≥20%) for trametinib were rash, diarrhoea, fatigue, oedema peripheral, nausea and dermatitis acneiform2
For more safety information on TAFINLAR and MEKINIST, click here.
For the full safety profile, please refer to the Summary of Product Characteristics (SmPC) for TAFINLAR and MEKINIST.
Adverse event reporting: Details of how to report adverse events are available at the bottom of the page. Please refer to the respective SmPC for all licensed indications.
Durable 5-year survival responses in metastatic melanoma
Pooled data of two large Phase III trials (N=563): COMBI-v* (vs vemurafenib) and COMBI-d (vs dabrafenib)† demonstrate a long-term PFS response with TAFINLAR + MEKINIST, that is maintained over 5 years (Year 2: 31%, Year 3: 24%, Year 4: 21%, Year 5: 19%).
COMBI-v (n=704): The mPFS was significantly higher at 11.4 months with the combination group compared with 7.3 months for vemurafenib (HR=0.56 [95% CI: 0.46–0.69]; p<0.001)4
COMBI-d (n=423): The mPFS was 9.3 months in the combination group and 8.8 months in the TAFINLAR-only group (HR=0.75 [95% CI: 0.57–0.99]; p=0.03)5
Select the COMBI-v & -d, COMBI-v, COMBI-d and COMBI-MB options below to discover more about TAFINLAR + MEKINIST efficacy in key studies of metastatic melanoma.3–6
In the extended follow-up of the COMBI-AD trial (N=870),‡ adjuvant TAFINLAR + MEKINIST led to a durable relapse-free survival rate at 5 years vs placebo in eligible patients with Stage III melanoma (52% vs 36%; HR=0.51 [95% CI: 0.42–0.61])5
Data demonstrate that the combination of TAFINLAR + MEKINIST offers patients a chance for durable RFS at 5 years (52% vs 36% in the placebo arm; HR=0.51 [95% CI: 0.42–0.61]).7,8
Select the COMBI-AD option below to learn more about TAFINLAR + MEKINIST efficacy as an adjuvant therapy
*COMBI-v (N=704) was an open-label, randomised Phase III study that assessed patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, the comparator BRAF inhibitor was vemurafenib monotherapy. Primary endpoint was OS. Secondary endpoints included PFS, ORR, DOR and safety profile.4
†COMBI-d (N=423) was a double-blind, randomised Phase III trial that assessed 1L patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. The comparator was TAFINLAR + placebo. The primary endpoint was PFS. Secondary endpoints included OS, ORR, DOR, safety profile and pharmacokinetics.5
‡COMBI-AD (N=870) was a double-blind, placebo-controlled, Phase III trial in patients with Stage III (Stage IIIA [lymph node metastasis ≥1 mm], IIIB, or IIIC) cutaneous melanoma with a BRAF V600 E/K mutation, following complete resection. Patients received either oral TAFINLAR at a dose of 150 mg twice daily plus MEKINIST at a dose of 2 mg once daily (combination therapy, 438 patients) or two matched placebo tablets (432 patients) for 12 months. The primary endpoint was relapse-free survival. Secondary endpoints included OS, DMFS, RFS, and safety profile.7
1L, first-line; BRAF V600 (E/K), mutation of the BRAF gene in which valine (V) is substituted at amino acid 600 with either glutamate (E) or lysine (K); DMFS, distant metastasis-free survival; DOR, duration of response; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; RFS, relapse-free survival; SmPC, summary of product characteristics.
References
TAFINLAR (dabrafenib) Summary of Product Characteristics.
MEKINIST (trametinib) Summary of Product Characteristics.
Robert C, et al. N Engl J Med 2019;381:626–636.
Robert C, et al. N Engl J Med 2015;372:30–39.
Long GV, et al. N Engl J Med 2014;371:1877–1888.
Davies MA, et al. Lancet Oncol 2017;18:863–873.
Dummer R, et al. N Engl J Med 2020;383(12):1139–1148.
Long GV, et al. N Engl J Med 2017;377:1813–1823.
UK | May 2025 | FA-11218038-1
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
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The Novartis portal for UK healthcare professionals (HCPs) and other relevant decision makers* is where you can find promotional information about Novartis products, therapy area materials and professional resources.
*Other relevant decision makers particularly includes those with an NHS role who could influence in any way the administration, consumption, prescription, purchase, recommendation, sale, supply or use of any medicine but who are not health professionals.
Welcome to Pro.Novartis.com
The Novartis portal for UK healthcare professionals (HCPs) and other relevant decision makers* is where you can find promotional information about Novartis products, therapy area materials and professional resources.
*Other relevant decision makers particularly includes those with an NHS role who could influence in any way the administration, consumption, prescription, purchase, recommendation, sale, supply or use of any medicine but who are not health professionals.