Prescribing information

 

   

Tafinlar (dabrafenib) + Mekinist (trametinib) – The first and only targeted therapy to show a DURABLE 5-year survival benefit in patients with BRAF V600 unresectable or metastatic melanoma vs. BRAF inhibitor alone1

Study designs are available at the end of this page.

In a pooled analysis of COMBI-v and COMBI-d trials, 34% of patients were alive at 5 years and 19% were progression-free1

Overall survival at 5 years of follow-up in the COMBI-v and COMBI-d trials in pooled analysis1

Graph showing overall survival at 5 years of follow-up in the COMBI-v and COMBI-d trials

Adapted from reference 1.

Overall survival at 5 years of follow-up in the COMBI-v trial1

Adapted from reference 1.

Overall survival at 5 years of follow-up in the COMBI-d trial1

Adapted from reference 1.

Progression-free survival at 5 years of follow-up in the COMBI-v and COMBI-d trials in pooled analysis1

Graph showing progression-free survival at 5 years of follow-up in the COMBI-v and COMBI-d trials

Adapted from reference 1.

Progression-free survival at 5 years of follow-up in the COMBI-v trial1

Adapted from reference 1.

Progression-free survival at 5 years of follow-up in the COMBI-d trial1

Adapted from reference 1.

Efficacy benefits were seen in patients with low tumour burden, with 55% of patients alive at 5 years and 31% progression-free1

Overall survival at 5 years of follow-up in patients with normal LDH and <3 disease sites from the COMBI-v and COMBI-d pooled analysis1

Graph showing survival at 5 years of follow-up in patients with low tumour burden from the COMBI-v and COMBI-d trials

Progression-free survival at 5 years of follow-up in patients with normal LDH and <3 disease sites from the COMBI-v and COMBI-d pooled analysis 1

Graph showing progression-free survival at 5 years of follow-up in patients with low tumour burden from the COMBI-v and COMBI-d trials

Nearly 20% of patients treated with Tafinlar + Mekinist achieved a complete response in the combined COMBI-v and COMBI-d trials1

Patients with favourable prognostic factors were more likely to achieve a complete response than the overall population

Patient response to treatment in the pooled COMBI-v/d trials

Diagram showing patient response to treatment in the pooled COMBI-v/d trials

*Indicates best overall response achieved at any point during the trials.

† Two patients were excluded as they had no measurable disease at baseline.

Overall Response Rate (Complete Response + Partial Response) for COMBI-v at 5 years was 67% in the Tafinlar + Mekinist arm vs. 53% in the vemurafenib arm.3,4 

Overall Response Rate (Complete Response + Partial Response) for COMBI-d at 5 years was 69% in the Tafinlar + Mekinist arm vs. 54% in the dabrafenib arm3,4

COMBI-v trial design5,6

 Diagram showing the COMBI-v trial design

Study endpoints:3

  • Primary endpoint: OS
  • Secondary endpoints included: PFS, ORR, DOR and safety

 

COMBI-d trial design7,8

Diagram showing the COMBI-d trial design

Study endpoints:7,8

  • Primary endpoint: Investigator-assessed PFS 
  • Secondary endpoints included: OS, ORR, DOR, safety and pharmacokinetics

b.d., twice daily; CI, confidence interval; CR, complete response; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HR, hazard ratio; LDH, lactate dehydrogenase; NE, not evaluable; o.d., once daily; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.

References

  1. Robert C et al. N Engl J Med 2019;381:626–636.
  2. Robert C et al. Pigment Cell Melanoma Res 2018;3:201.
  3. Tafinlar (dabrafenib) Summary of Product Characteristics.
  4. Mekinist (trametinib) Summary of Product Characteristics.
  5. Robert C et al. N Engl J Med 2015;372:30–39.
  6. Robert C et al. Presented at ESMO 2016: 7–11 October, Copenhagen, Denmark.
  7. Long GV et al. Ann Oncol 2017;28(7):1631–1639.
  8. Long GV et al. Lancet 2015;386:444–451.
TMC20-C004c May 2020
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