PFS per Investigator
Percentage of PFS
PFS per Investigator (Months)
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0
3
6
9
12
15
18
30
24
21
27
176
233
111
121
77
99
60
83
12
20
149
139
94
109
73
96
38
48
0
0
Number of patients at risk:
Discontinued due to an AE
Did not discontinue due to an AE
0
2
Probability of PFS
NIVO+IPI DC
(n = 176)
NIVO+IPI no DC
(n = 233)
Median PFS, months (95%
CI)
16.7 (10.2, NA) 10.8 (5.9, 23.0)
HR (99.5% CI)
0.74 (0.56, 0.98),
P
< 0.04
49.3
%
45.9
%
52.2
%
48.4
%
71.7
%
56.5
%
DC
=
patients who discontinued due to an AE; NA
=
not available; no DC
=
patients who did not discontinue due to an AE.
Efficacy and safety outcomes in patients with advanced melanoma
(MEL) who discontinued treatment with nivolumab (NIVO) plus
ipilimumab (IPI) due to toxicity
Schadendorf, D et al. EADO 2016
DC
=
patients who discontinued due to an AE; no DC
=
patients who did not discontinue due to an AE; NR = not recorded.
1. Larkin J et al.
N Engl J Med.
2015;373:23-34. 2. Used with permission by Wolchok JD et al. ASCO 2016.
•
Minimum follow-up of 18 months, median length of follow-up = 21.3 months
Best Overall Response
NIVO+IPI
Discontinue
d due to AEs
(n = 176)
Did not
discontinue
due to AEs
(n = 233)
ORR, % (95% CI)
68.2
(60.8, 75.0)
50.2
(43.6, 56.8)
P
value for
comparison
0.0200
Best overall response, %
Complete response
17.6
12.0
Partial response
50.6
38.2
Stable disease
15.9
10.7
Progressive disease
13.1
27.0
Unable to determine
2.8
12.0
Time to Response and Durability of Response in Patients
Who Discontinued Due to AEs
Patients
0
8 16 24 32 40 48 56 64 72 80 88 96 104 112 120
Time (Weeks)
On treatment
Off treatment
First response
Ongoing response
NIVO + IPI
DC
(n =
176)
No DC
(n =
233)
Median time to
response, months
(range)
2.8
(1.1-
15.2)
2.8
(1.4-
17.1)
Median duration of
response, months
(range)
NR
NR
Ongoing response
among responders,
n/N (%)
82/120
(68)
94/117
(80)
P
value = 0.0213
• Minimum follow-up of 18 months
C
=
patients who discontinued due to n AE; no DC
=
pa ents who did not disc ntinue due to an AE; NR = not recorded.
