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Metastatic treatment – Efficacy
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
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
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
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
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
*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.2,3
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 arm2,3
COMBI-v trial design4,5
Study endpoints:2
- Primary endpoint: OS
- Secondary endpoints included: PFS, ORR, DOR and safety
COMBI-d trial design6,7
Study endpoints:6,7
- 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
- Robert C et al. N Engl J Med 2019;381:626–636.
- Tafinlar (dabrafenib) Summary of Product Characteristics.
- Mekinist (trametinib) Summary of Product Characteristics.
- Robert C et al. N Engl J Med 2015;372:30–39.
- Robert C et al. Presented at ESMO 2016: 7–11 October, Copenhagen, Denmark.
- Long GV et al. Ann Oncol 2017;28(7):1631–1639.
- Long GV et al. Lancet 2015;386:444–451.