Innovative Therapeutics in Oncology and Neuroscience
Approved
ZEJULA
Only PARP Inhibitor Approved in First-Line Ovarian Cancer for All Comers Regardless
of Biomarker Status (PRIMA and PRIME Study)
100
90
80
60
10
70
China PRIME Study - ZEJULA demonstrated a statistically significant and clinically meaningful improvement in PFS with a
tolerable safety profile in Chinese patients with newly diagnosed ovarian cancer following a response to platinum-based
chemotherapy, regardless of biomarker status
PFS (by BICR) in the ITT Population - Primary Endpoint
HR (95% CI), 0.45 (0.34ā0.60)
p<0.001
16.5 months longer
median PFS with
niraparib versus placebo
Progression-free survival (%)
60
60
50
50
40-
30-
++
20
Niraparib
10-
+ Placebo
Median follow-up: 27.5 months
Censored observation
0
0
3
6
9
12
15
18
21
24
-24
27
30
33
36
39
Months since randomization
Number at risk
255
129
227
101
207
74
186
54
170
44
151
40
136
37
125
36
103
32
72
41
24
17
34
13
0
1
0 0
Niraparib Placebo
(N=255)
(N=129)
PFS (54.4% data maturity)
Events, n (%) 123 (48.2)
(95% CI), months (19.2-NE)
Patients without PD or death (%)
86 (66.7)
mPFS
24.8
8.3
(7.3-11.1)
24 months
52.6
30.4
.
ā« The safety profile of niraparib was
improved with ISD prospectively
applied to all patients
23
Abbreviations: Blinded independent central review (BICR), confidence interval (CI), hazard ratio (HR), intention-to-treat (ITT), median progression-free survival (mPFS), not estimable (NE), progressive disease (PD), overal surival (OS), individualized
starting dose (ISD).
Note: Additional efficacy and safety data from the Phase 3 PRIME study of ZEJULA (niraparib) presented by Dr. Lingying Wu, Director of the Department of Gynecologic Oncology, National Cancer Center / National Clinical Research Center for Cancer /
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Society of Gynecologic Oncology Annual Meeting, March 2022.
Clinical Data -
OncologyView entire presentation