KEYNOTE-052: efficacy
Only confirmed responses are reported. Data cut-off date: 1 June 2016
a
3 patients had stable disease within 6 weeks of treatment start
and then discontinued
b
10 patients dropped out of the study before the first
post-baseline imaging, either due to clinical progression or AE
c
Only confirmed responses are included (n=24)
Balar et al. ESMO 2016
N=100
n
% (95% CI)
ORR
24 24% (16–34)
CR
6
6% (2
–
13)
PR
18 18% (11
–
27)
SD
15
15% (9
–
24)
Progressive disease
48 48% (38
–
58)
Non-evaluable
a
3
3% (1
–
9)
No assessment
b
10
10% (5
–
18)
Confirmed ORR per RECIST v1.1, central
review
Treatment exposure and response duration
c
0
10
20
30
40
50
60
Weeks
PR or CR
PD
Last dose
+
Median follow-up duration
•
8 months (range, 0.1–13.4)
Median time to response
•
2.0 months (range, 1.9–4.8)
Median duration of response
•
Not reached (range, 1.4+ to 9.8+ months)
•
Duration of response ≥6 months: 83%
