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TAFINLAR in combination with MEKINIST is indicated in adult patients for the treatment of BRAF V600 positive, unresectable or metastatic melanoma, and in the adjuvant setting for Stage III BRAF V600 positive melanoma, following complete resection.1,2
Please refer to the respective SmPCs for all licensed indications.
Durable five-year survival benefit in metastatic melanoma
Pooled data of two large Phase III trials: COMBI-v* (vs. vemurafenib) and COMBI-d (vs. dabrafenib)† demonstrate TAFINLAR + MEKINIST achieves a long-term progression-free survival benefit versus BRAF inhibitor alone, that is maintained over 5 years.3
Select the COMBI-v & -d, COMBI-d, COMBI-v and COMBI-MB options below to discover more about TAFINLAR + MEKINIST efficacy in key studies of metastatic melanoma.
Results from the COMBI-AD‡ trial demonstrated durable relapse-free survival at five years as an adjuvant therapy for eligible Stage III melanoma, compared to placebo4
Data demonstrate that the combination of TAFINLAR + MEKINIST offers patients a chance for DURABLE relapse-free survival at five years.4,5
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.6
†COMBI-d (N=423) was a double-blind, randomised Phase III trial assessed 1L patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. The comparator was dabrafenib + placebo. Primary endpoint was PFS. Secondary endpoints included OS, ORR, DOR, safety and pharmacokinetics.7
‡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 dabrafenib at a dose of 150 mg twice daily plus trametinib at a dose of 2 mg once daily (combination therapy, 438 patients) or two matched placebo tablets (432 patients) for 12 months. The primary end point was relapse-free survival. Secondary end points included overall survival, distant metastasis–free survival, freedom from relapse, and safety.4
DOR, duration of response; ORR, overall response rate; OS, overall survival; PFS, progression-free
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.
- Long GV, et al. N Engl J Med 2017;377:1813–1823.
- Dummer R, et al. N Engl J Med 2020;383(12):1139–1148.
- Robert C, et al. N Engl J Med 2015;372:30–39.
- Long GV, et al. N Engl J Med 2014;371:1877–1888.