Innovative Therapeutics in Oncology and Neuroscience
25
ZEJULA
Favorable Overall Survival (OS) Trend in All Patient Groups Compared with Placebo (NORA Study)
Approved
China NORA Phase 3 Study - Interim OS Analysis at 2022 ESMO Virtual Plenary 1,2
OS in the ITT Population
OS Subgroup Analysis in gBRC Amut
OS Subgroup Analysis in non-gBRCAmut
Median OS
(months)
Niraparib
(n=177)
Placebo
(n=88)
Median OS
(months)
Niraparib
(n=65)
Placebo
(n=35)
Median OS
(months)
Niraparib
(n=112)
Placebo
(n=53)
Months (95%
CI)
46.32
(41.03-NE) (33.08-NE)
43.37
Months (95%
CI)
NR
(35.38-NE)
47.61
(31.57-NE)
Months (95%
CI)
43.10
(38.41-NE)
38.41
(29.54-NE)
Hazard Ratio
(95% CI)
Hazard Ratio
(95% CI)
0.76
(0.40-1.46)
Hazard Ratio
(95% CI)
0.86
(0.53-1.38)
Once-daily oral
Zejula
niraparib
capsules 100 mg
0.82
(0.56-1.21)
Key Conclusion
ZEJULA maintenance treatment using an
individualized starting dose (ISD) regimen
provides a favorable OS trend
irrespective of gBRCA status compared
with placebo
•
Next Steps & Core Opportunity
Full OS analysis of the NORA study is expected at an
upcoming medical conference in 2024
⚫ Zai Lab independently conducted the PRIME study for
first-line ovarian cancer in China
Abbreviations: overall survival (OS), intention to treat (ITT), confidence interval (CI), not evaluable (NE), not reached (NR).
Sources: Zai Lab presentation at 2022 ESMO Virtual Plenary; Globocan, 2020.
Notes: (1) Ad hoc Interim Overall Survival Results of Niraparib with Individualized Starting Dose as Maintenance Therapy in Patients with Platinum-Sensitive Recurrent Ovarian Cancer (NORA): A Double-blind, Randomized, Placebo-controlled, Phase 3
trial; Data cutoff date was September 23, 2022; (2) Median follow-up time for OS in niraparib and placebo arm was 45.7 and 44.5 months.
Clinical Data -
OncologyView entire presentation