Prescribing information

 

   

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

Please visit the COMBI-d and COMBI-v pooled efficacy and pooled safety pages for further information on the landmark five-year analysis of the two trials.

Image showing the study design for the COMBI-v study showing also the study endpoints

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

 

Table showing the COMBI-v efficacy results (five years of follow-up)

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

 

Graph of 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

 

Graph of 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

 

Graph of change from baseline in global health status (EORTC QLQ-C30)4

References

  1. Robert C, et al. N Engl J Med 2019;381:626–636.
  2. Robert C, et al. N Engl J Med 2015;372:30–39.
  3. MEKINIST (trametinib) Summary of Product Characteristics.
  4. Grob J-J, et al. Lancet Oncol 2015;16:1389–1398.
UK | December 2020 | 100906
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
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