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VP7-2022: An 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 III trial
Published: December 15, 2022
DOI: https://doi.org/10.1016/j.annonc.2022.11.007
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M.R. Mirza, X. Wu, J. Zhu, R. Yin, J. Yang, J. Liu, J. Wang, L. Wu, Z. Liu, Y. Gao, D. Wang, G. Lou, H. Yang, Q. Zhou, B. Kong, Y. Huang, L. Chen, X. Zhen, J. Dong, J. Hou
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Background
Niraparib has previously shown efficacy in a phase 3 NORA trial, which demonstrated significantly improved PFS in patients with platinum-sensitive recurrent ovarian cancer (PSROC). The aim of this adhoc interim analysis is to investigate the effect of niraparib on OS with individualized starting dose (ISD).
Methods
This double-blind, placebo-controlled, randomized, phase 3 NORA trial enrolled 265 Chinese patients with PSROC who achieved a CR or PR to the last platinum-based chemotherapy (NCT03705156). A majority of patients (249/265) was randomized (2:1) to receive niraparib or placebo by individualized starting dose according to baseline body weight and platelet count (200 mg for patients with baseline body weight < 77 kg or platelet count < 150,000/μL; otherwise, 300 mg). OS analysis was adopted by an ITT method and a censoring method for patients in placebo who were switched to PARPi.
Results
Patients were randomized to receive niraparib (n = 177) or placebo (n = 88). Data cut-off occurred on Sep. 23, 2022. Median follow-up time for OS in niraparib and placebo arm was 45.7 and 44.5 mos, respectively. An adhoc interim OS analysis was conducted at 44% (117/265) maturity. Using ITT method, mOS was numerically longer for patients receiving niraparib versus placebo in the ITT population: 46.3 [95% CI, 41.0-NE] versus 43.4 (95% CI, 33.1-NE) mos [HR =0.826; 95% CI, 0.56-1.21]. Forty three percent (38/88) patients in the placebo arm received subsequent PARPi therapy. A consistent OS trend was observed by censoring patients receiving PARPi in placebo arm, regardless of gBRCA status. Detailed data are provided in the table. No new safety signals were identified.
Conclusions
NORA showed a potentially favorable OS trend irrespective of gBRCA status with niraparib maintenance treatment using an ISD regimen for patients with PSROC.
Clinical trial identification: NCT03705156.
Legal entity responsible for the study: Zai Lab (Shanghai) Co., Ltd.
Funding: This work was supported by Zai Lab and also partially supported by the National Major Scientific and Technological Special Project for ‘Significant New Drugs Development’ in 2018, China (grant number 2018ZX09736019).
Disclosure: M.R. Mirza: Financial Interests, Personal, Advisory Board: AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche, Zai Lab; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK, Karyopharm; Financial Interests, Personal, Stocks/Shares: Karyopharm; Financial Interests, Institutional, Research Grant: GSK, AstraZeneca, Ultimovacs, Apexigen; Financial Interests, Institutional, Invited Speaker: Deciphera; Non-Financial Interests, Personal, Advisory Role: Ultimovacs, Apexigen.
X. Zhen: Financial Interests, Personal, Full or part-time Employment: Zai Lab (US) LLC; Financial Interests, Personal, Stocks/Shares: Zai Lab (US) LLC.
J. Dong, J. Hou: Financial Interests, Personal, Full or part-time Employment: Zai Lab (Shanghai) Co., Ltd; Financial Interests, Personal, Stocks/Shares: Zai Lab (Shanghai) Co., Ltd.
All other authors have declared no conflicts of interest.
