Prescribing information

 

   

DURABLE five-year survival benefit1

TAFINLAR (dabrafenib) + MEKINIST (trametinib), the first targeted therapy to show a DURABLE five-year survival benefit in adult patients with BRAF V600-positive unresectable or metastatic melanoma vs. BRAF inhibitor alone1

 

Key Clinical Data Insights From COMBI-v and COMBI-d

The efficacy and safety of TAFINLAR+MEKINIST for the treatment of adult patients with BRAF V600-positive unresectable or metastatic melanoma has been studied in two large Phase III trials: COMBI-v (vs. vemurafenib) and COMBI-d (vs. dabrafenib).2–4 A pooled analysis was performed on the data from the TAFINLAR + MEKINIST treatment arms of these two trials. In a landmark five-year analysis of the trials, TAFINLAR + MEKINIST demonstrated that:

Image of table demonstrating what in a landmark five-year analysis of the trials TAFINLAR+MEKINIST discovered

*Indicates best overall response achieved at any point during the trials.
ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase.

Please visit the COMBI-v efficacy, COMBI-d efficacy and pooled safety pages for further information on the two trials.

The pooled population consisted of 563 first-line adult patients with BRAF V600-positive unresectable or metastatic melanoma. All patients in the analysis had been randomised to receive TAFINLAR 150 mg BID + MEKINIST 2 mg QD in either COMBI-v or COMBI-d. Median follow-up was 22 months (range, 0–76).1

Image of chart detailing COMBI-v and COMBI-d Study Design

In the pooled analysis of COMBI-v and COMBI-d trials, 34% of patients treated with TAFINLAR + MEKINIST were alive at five years1

 

Overall survival at five years of follow-up1

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

More than half of patients with low tumour burden treated with TAFINLAR + MEKINIST were alive at five years1

 

Overall survival at five years of follow-up in patients with low tumour burden (normal LDH and <3 disease sites)1

Image detailing overall survival at five years of follow-up in patients with low tumour burden (normal LDH and <3 disease sites)1

In patients with elevated LDH levels taking TAFINLAR + MEKINIST, 16% were alive at five years (n=196).1

19% of patients treated with TAFINLAR + MEKINIST were progression-free and alive at five years1

 

Progression-free survival at five years of follow-up1

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

Nearly one third of patients with low tumour burden treated with TAFINLAR + MEKINIST were progression-free and alive at five years1

 

Progression-free survival at five years of follow-up in patients with low tumour burden (normal LDH and <3 disease sites)1

Image of graph detailing progression-free survival at five years of follow-up in patients with low tumour burden(normal LDH and <3 disease sites)1

In patients with elevated LDH levels taking TAFINLAR + MEKINIST, 8% were progression-free and alive at five years (n=196).1

Nearly one in five (19%) patients treated with TAFINLAR + MEKINIST achieved a complete response1,a

 

Patients with favourable prognostic factors (normal LDH, <3 disease sites, ECOG performance status of 0) were more likely to achieve a complete response than the overall population.1

Best RECIST response in the pooled analysis – five-year follow-up analysis (n=561)1,a

Image of pie chart detailing best RECIST response in the pooled analysis – five-year follow-up analysis (n=561)

aIndicates best overall response achieved at any point during the trials. Two patients were excluded from the five-year pooled analysis because they had no measurable disease at baseline.

Patients with favourable prognostic factors were more likely to gain a complete response than the overall population1

 

Baseline characteristics in patients with complete response1

Image of table and pie charts detailing baseline characteristics in patients with complete response

DURABLE benefit at three years of follow-up, with 58% of patients remaining in complete response5

 

Based on an earlier three-year analysis of the pooled COMBI-v and COMBI-d trial data, 58% of patients who achieved a complete response with TAFINLAR + MEKINIST remained in complete response (median duration 39.6 months).5

Patients with a partial response did not experience the same duration of response as their complete response counterparts.5

Treatment response in patients with complete response (n=106) – three-year follow-up analysis5

Image of graph detailing treatment response in patients with complete response (n=106) – three-year follow-up analysis

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. Long G, et al. N Engl J Med 2014;371:1877–1888.
  4. Long G, et al. Lancet 2015;386:444–451.
  5. Robert C, et al. Pigment Cell Melanoma Res 2018;31:201.
UK | December 2020 | 100912
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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