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 Five-Year Survival Benefit3
TAFINLAR + MEKINIST showed DURABLE responses up to five years in adult patients with BRAF V600-positive unresectable or metastatic melanoma3
Key Clinical Data Insights From COMBI-v and COMBI-d
The efficacy and safety of TAFINLAR+MEKINIST for the treatment of adult patients with BRAF V600-positive unresectable or metastatic melanoma has been studied in two large Phase III trials: COMBI-v (vs. vemurafenib) and COMBI-d (vs. dabrafenib).4–6 A pooled analysis was performed on the data from the TAFINLAR + MEKINIST treatment arms of these two trials. In a landmark five-year analysis of the trials, TAFINLAR + MEKINIST demonstrated that:
More than one in three (34%) patients treated with TAFINLAR + MEKINIST were alive at five years.3
More than half (55%) of patients with low tumour burden (normal LDH and <3 disease sites) treated with TAFINLAR + MEKINIST were alive at five years.3
Nearly one in five (19%) patients treated with TAFINLAR + MEKINIST were still progression-free at five years.3
Complete response* is possible for nearly one in five (19%) patients treated with TAFINLAR + MEKINIST – for those patients with a complete response to treatment, overall survival (OS) was 71% and progression-free survival (PFS) was 49% at five years.3
Patients with favourable prognostic factors (normal LDH, <3 disease sites, ECOG performance status of 0) were more likely to achieve complete response and long-term overall survival than the overall population.3
Please visit the COMBI-v efficacy, COMBI-d efficacy and pooled safety pages for further information on the two trials.
The pooled population consisted of 563 first-line adult patients with BRAF V600-positive unresectable or metastatic melanoma. All patients in the analysis had been randomised to receive TAFINLAR 150 mg BID + MEKINIST 2 mg QD in either COMBI-v or COMBI-d. Median follow-up was 22 months (range, 0–76).3
*Indicates best overall response achieved at any point during the trials.
BID, twice daily; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QD, once daily; R, randomised.
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 G, et al. N Engl J Med 2014;371:1877–1888.
- Long G, et al. Lancet 2015;386:444–451.
- Robert C, et al. Pigment Cell Melanoma Res 2018;31:201.