Innovative Therapeutics in Oncology and Neuroscience
Approved
ZEJULA
First Fully Powered, Randomized, Controlled (RCT) Phase 3 Trial Ever Conducted
in Ovarian Cancer in China (NORA Study)
China NORA study - An individualized starting dose (ISD) regimen preserved efficacy and improved safety profile in Chinese
patients, underscoring the promise of ZEJULA as a maintenance therapy for Chinese patients with platinum-sensitive recurrent
ovarian cancer
100
☑
PFS (by BICR) in the ITT Population - Primary Endpoint
70% Reduction of Hazard for Relapse or Death
with Niraparib
80
60
60
60
Progression-free Survival, %
40
40
Niraparib
--Placebo
X
Median PFS
Niraparib
(n=166)
Placebo
(n=83)
Months (95% CI)
18.3
(11.0-NE)
5.4
(3.7-5.7)
Hazard Ratio (95% CI)
0.30
(0.21-0.43)
p-value*
<0.0001
Clinical Data -
Oncology
0
T
T
0 2
4
6 8 10 12 14
Time Since Randomization (months)
16 18
20
20
No. of Patients at Risk
Niraparib 166 151 129 110 97 86 67 40 22 22 5
Placebo
83 62 40 26 16 10 9 6
6
6
Current Status
22
22
24
•
.
1
0
Only PARP inhibitor included in the NRDL as first-line and
recurrent maintenance treatment for ovarian cancer patients
regardless of biomarker status in China
*p-value is from stratified log-rank test
China NORA study met all primary and secondary endpoints
ISD regimen based on weight and platelets was shown to be
effective, with lower rates of anemia and thrombocytopenia
Core Opportunity
The leader in PARPi hospital sales for ovarian cancer in
China (~55K incidence)
24
20
20
Abbreviations: Randomized clinical trial (RCT), blinded independent central review (BICR), confidence interval (CI), intention-to-treat (ITT), progression-free survival (PFS), not estimable (NE).
Sources: Zai Lab ESMO presentation, September 2020; Globocan, 2020.View entire presentation