Prescribing information

 

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COMBI-AD trial showed 49% reduction in risk of relapse or death after median follow-up of 60 months with Tafinlar (dabrafenib) + Mekinist (trametinib) vs. placebo1

 

  • 5-year Relapse-Free Survival (RFS), the primary endpoint, was 52% (95% CI: 48–58%) in the TAFINLAR + MEKINIST arm vs. 36% (95% CI: 32–41%) in the placebo arm (HR: 0.51, 95% CI: 0.42–0.61)1

 

Relapse-free survival rates for the COMBI-AD trial1

No overall survival (OS) analysis was conducted at 5 years due to predefined group sequential testing scheme. The final OS analysis will be performed when 299 OS events have occurred.
 

86% of patients treated with Tafinlar + Mekinist were alive at 3 years vs. 77% for patients receiving placebo in the COMBI-AD trial (p=0.0006, non significant)2*

 

Overall survival for patients in the COMBI-AD trial2

Exploratory Quality of Life Assessments3
 

  • Health-related quality of life (HRQoL) were reported during 12-month treatment and long-term follow-up periods3
  • HRQoL assessment using the EuroQoL EQ-5D-3L questionnaire (utility score) and visual analogue scale (VAS) was an exploratory endpoint3
  • Patients on Tafinlar + Mekinist did not report any clinically meaningful reduction in QoL during treatment or follow-up compared with the placebo arm3
  • Notably, experiencing a common adverse event while taking Tafinlar + Mekinist did not result in any clinically meaningful change in QoL, which improved over time3
  • QoL decreased in both treatment arms upon disease recurrence, demonstrating the value of remaining recurrence free3

 

Trial design for COMBI-AD2

This was a two-arm, randomised, double-blind phase III study of TAFINLAR + MEKINIST vs. two placebos in the adjuvant treatment of melanoma after surgial resection2

Study endpoints:2

  • Primary endpoint: Relapse-free survival (RFS)
  • Secondary endpoints: Overall survival (OS), distant metastasis-free survival (DMFS), freedom from relapse (FFR), and safety

 


    b.d., twice daily; CI, confidence interval; HR, hazard ratio; ECOG, European Cooperative Oncology Group; QoL, quality of life; o.d., once daily; OS, overall survival; RFS, relapse-free survival.

    References

    1. Dummer R et al. Five-year relapse-free survival with adjuvant dabrafenib plus trametinib in stage III BRAF-mutant melanoma. N Eng J Med 2020;382.
    2. Long GV et al. N Engl J Med 2017;377:1813–1823.
    3. Schadendorf D et al. Presented at ASCO 2018; 1–5 June, Chicago, USA.
    TMC20-C004f May 2020
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