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:
*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
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
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
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
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
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
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
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
References
- Robert C, et al. N Engl J Med 2019;381:626–636.
- Robert C, et al. N Engl J Med 2015;372:30–39.
- Long G, et al. N Engl J Med 2014;371:1877–1888.
- Long G, et al. Lancet 2015;386:444–451.
- Robert C, et al. Pigment Cell Melanoma Res 2018;31:201.