Prescribing information

 

Durable five-year survival benefit1

COMBI-d was a double-blind, randomised Phase III study that compared TAFINLAR (dabrafenib) + MEKINIST (trametinib) vs. TAFINLAR monotherapy in adult patients with BRAF V600-positive metastatic melanoma.2,3  

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 of flowchart detailing study design for COMBI-d

TAFINLAR + MEKINIST significantly improved progression-free survival, overall response rate and overall survival vs. TAFINLAR monotherapy4

 

COMBI-d efficacy results (five years of follow-up)4

 

Image of table detailing COMBI-d efficacy results (five years of follow-up)4

17% of patients treated with TAFINLAR + MEKINIST were progression-free and alive at five years vs. 13% of patients treated with TAFINLAR + placebo1

 

Progression-free survival at five years of follow-up1

 

Image of graph detailing progression-free survival at five years of follow-up1

32% of patients treated with TAFINLAR + MEKINIST were alive at five years vs. 27% of patients treated with TAFINLAR + placebo1

 

Overall survival at five years of follow-up1

 

Image of graph detailing overall survival at five years of follow-up1

TAFINLAR + MEKINIST significantly improved many aspects of patient-reported health-related quality of life compared with TAFINLAR monotherapy and patients had sustained quality of life during treatment5

 

Health-Related Quality of Life

Health-Related Quality of Life (HRQoL) was evaluated in the COMBI-d 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.5

  • HRQoL was significantly better for patients receiving TAFINLAR + MEKINIST, and resulted in sustained quality of life, compared with those on TAFINLAR monotherapy at several assessment time points.5
  • There were also improvements in the majority of functional dimensions (physical, social, role, emotional and cognitive functioning) in favour of the combination, with pain scores significantly improved and clinically meaningful at all assessments. For other symptom dimensions (nausea and vomiting, diarrhoea, dyspnoea, and constipation), scores trended in favour of TAFINLAR monotherapy.5

References

  1. Robert C, et al. N Engl J Med 2019;381:626–636.
  2. Long G, et al. N Engl J Med 2014;371:1877–1888.
  3. Long G, et al. Lancet 2015;386:444–451.
  4. MEKINIST (trametinib) Summary of Product Characteristics.
  5. Schadendorf D, et al. Eur J Cancer 2015;51:833–840.
UK | December 2020 | 100904
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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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