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34 Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 trial
  1. Xiaohua Wu1,
  2. Jianqing Zhu2,
  3. Rutie Yin3,
  4. Jiaxin Yang4,
  5. Jihong Liu5,
  6. Jing Wang6,
  7. Lingying Wu7,
  8. Ziling Liu8,
  9. Yunong Gao9,
  10. Danbo Wang10,
  11. Ge Lou11,
  12. Hongying Yang12,
  13. Qi Zhou13,
  14. Beihua Kong14,
  15. Yi Huang15,
  16. Zhao Huang16,
  17. Juan Dong16,
  18. Charlie Zhang16,
  19. Jianmei Hou16 and
  20. Mansoor R Mirza17
  1. 1Fudan University Shanghai Cancer Center, Shanghai, China
  2. 2Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China
  3. 3West China Second University Hospital, Sichuan University, Chengdu, China
  4. 4Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
  5. 5Sun Yat-sen University Cancer Center, Guangzhou, China
  6. 6Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China
  7. 7National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
  8. 8The First Hospital of Jilin University, Changchun, China
  9. 9Peking University Cancer Hospital and Institute, Beijing, China
  10. 10Liaoning Cancer Hospital and Institute, Shenyang, China
  11. 11Harbin Medical University Cancer Hospital, Harbin, China
  12. 12The Third Affiliated Hospital of Kunming Medical University (Yunnan Cancer Hospital), Kunming, China
  13. 13Chongqing University Cancer Hospital, Chongqing, China
  14. 14Qilu Hospital of Shandong University, Ji’Nan, China
  15. 15Hubei Cancer Hospital, Wuhan, China
  16. 16Zai Lab (Shanghai) Co., Ltd, Shanghai, China
  17. 17Rigshospitalet-Copenhagen University Hospital, Copenhagen, Denmark


Introduction/Background In the randomised, double-blind, placebo-controlled phase 3 NORA trial (NCT03705156) among patients with platinum-sensitive recurrent ovarian cancer (PSROC), niraparib maintenance therapy using an individualised starting dose (ISD) demonstrated a significant improvement in progression-free survival at the primary analysis and a favourable trend in overall survival (OS) at an interim analysis, irrespective of germline BRCA mutation (gBRCAm) status. In contrast, an inconsistent OS trend was observed among patients without gBRCAm across similar trials of poly(ADP-ribose) polymerase inhibitors (PARPis) in the same setting. This analysis aimed to present the final OS data of NORA.

Methodology Eligible patients who were adults with PSROC and responded to their last platinum-based chemotherapy were randomised (2:1) to receive niraparib or placebo once daily. Following a protocol amendment, an ISD was used: 200 mg for those with bodyweight <77 kg and/or platelet count <150×103/µL and 300 mg otherwise. NORA was not powered for OS analysis. This planned, descriptive, final OS analysis was conducted after ≥50% of OS events occurred in the intention-to-treat population.

Results Totally, 265 patients were randomised (177 niraparib; 88 placebo) and 249 (94.0%) received an ISD. Baseline characteristics were well balanced between the two groups. By the data cut-off (14 August 2023), median follow-up for OS was 57.9 months (IQR, 54.8–61.6). Notably, 41 (46.6%) placebo-treated patients received subsequent PARPi therapy. With 138 (52.1%) OS events reported, median OS (95% CI) in the overall population was 51.5 months (41.4–58.9) with niraparib and 47.6 months (33.3-not evaluable) with placebo (HR, 0.86; 95% CI, 0.60–1.23). A consistent OS trend was observed in both patients with and without gBRCAm (table 1). No new safety signal was identified for niraparib.

Conclusion Niraparib maintenance therapy using ISD demonstrated a favourable OS trend versus placebo in patients with PSROC, regardless of gBRCAm status.

Disclosures Charlie Zhang, Jianmei Hou, Zhao Huang, Juan Dong are employees of Zai Lab. They have stocks of Zai Lab. Mansoor R. Mirza has received the grants/research support from GSK, AstraZeneca, Ultimovacs, Apexigen, Deciphera. Mansoor R. Mirza received the honoraria or consultation fees from AstraZeneca, Biocad, GSK, Karyopharm, Merck, Roche, Zai Lab, is the stock shareholder of Karyopharml. Mansoor R. Mirza has some Non-Financial Interests: Advisory role (Ultimovacs, Apexigen). Member of Board of Directors: Karyopharm

Abstract 34 Table 1

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