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Integrated Efficacy Results:
1º End-Point: Overall Response Rates(ORR)
§
Investigator-assessed confirmed
ORR per RECIST v1.1 53.8%
(95% CI 43.8–63.5)
§
Independent radiology review confirmed ORR per RECIST v1.1 of 41.5% (95% CI 32.0–51.5); 4.7% of patients achieved a complete
response and 36.8% achieved a partial response
ORR,
% (n) [95% CI]
†
Study 10 (n=42)
ARIEL2 (n=64)
Pooled efficacy population (n=106)
59.5 (25)
[43.3–74.4]
50.0 (32)
[37.2–62.8]
53.8 (57)
[43.8–63.5]
Best overall response, % (n)
Complete response
9.5 (4)
7.8 (5)
8.5 (9)
Partial response
50.0 (21)
42.2 (27)
45.3 (48)
Stable disease
28.6 (12)
37.5 (24)
34.0 (36)
Progressive disease
4.8 (2)
10.9 (7)
8.5 (9)
Not evaluable
7.1 (3)
1.6 (1)
3.8 (4)
Oza AM et al.
Gynecol Oncol
. 2017;147:267–275