Durable five-year survival benefit1
COMBI-v was an open-label, randomised Phase III study that compared TAFINLAR (dabrafenib) + MEKINIST (trametinib) vs. vemurafenib monotherapy in adult patients with BRAF V600-positive metastatic melanoma.2
TAFINLAR + MEKINIST significantly improved overall survival, progression-free survival and overall response rate vs. vemurafenib monotherapy3
COMBI-v efficacy results (five years of follow-up)3
36% of patients treated with TAFINLAR + MEKINIST were alive at five years vs. 23% of patients treated with vemurafenib1
Overall survival at five years of follow-up1
20% of patients treated with TAFINLAR + MEKINIST were progression-free and alive at five years vs. 9% of patients treated with vemurafenib1
Progression-free survival at five years of follow-up1
TAFINLAR + MEKINIST significantly improved many aspects of patient-reported health-related quality of life compared with vemurafenib monotherapy and patients had sustained quality of life during treatment4
Health-Related Quality of Life
Health-related quality of life (HRQoL) was evaluated in the COMBI-v study (pre-specified exploratory analysis) using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30, which was completed over three years, at baseline, during study treatment, at progression and post-progression.4
- Patients treated with TAFINLAR + MEKINIST had a statistically significant and clinically meaningful improvement in overall HRQoL (as measured by global health status), and sustained quality of life, compared with vemurafenib monotherapy at all assessment time points.4
- There were also statistically significant and clinically meaningful improvements in functional aspects of HRQoL and in symptoms (pain, insomnia, appetite loss, diarrhoea) for TAFINLAR + MEKINIST vs. vemurafenib at the majority of assessments.4
Change from baseline in global health status (EORTC QLQ-C30)4
- Robert C, et al. N Engl J Med 2019;381:626–636.
- Robert C, et al. N Engl J Med 2015;372:30–39.
- MEKINIST (trametinib) Summary of Product Characteristics.
- Grob J-J, et al. Lancet Oncol 2015;16:1389–1398.