9 / 36
UPDATE ON RFS EVENTS
Median Follow-Up (D + T) – 44 Months; Minimum Follow-Up – 40 Months
Primary Analysis
Data Cutoff: June 30, 2017
Updated Analysis
Data Cutoff: April 30, 2018
First Relapse Event, n (%)
D + T
(n = 438)
Placebo
(n = 432)
D + T
(n = 438)
Placebo
(n = 432)
Relapsed
163 (37)
247 (57)
174 (40)
253 (59)
Local/regional relapse only
a
54 (33)
107 (43)
56 (32)
110 (43)
Distant relapse only
a
96 (59)
126 (51)
102 (59)
130 (51)
Concurrent local and distant
relapse
a
7 (4)
7 (3)
9 (5)
6 (2)
New primary melanoma
a,b
7 (4)
8 (3)
9 (5)
8 (3)
Died (event)
c
3 (< 1)
1 (< 1)
3 (< 1)
1 (< 1)
a
Percentage based on the number of patients with relapse.
b
At the primary analysis, 1 patient in each arm had disease relapse and new primary melanoma observed on the same day. At the
updated cutoff, 2 patients in the dabrafenib + trametinib arm and 1 patient in the placebo arm had both disease relapse and new primary melanoma observed on the same day.
c
Includes only
patients who died before any observation of relapse or new primary melanoma event.
Long G, et al. ESMO 2018