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453 Senaparib maintenance in newly diagnosed advanced ovarian cancer: FLAMES study
  1. Xiaohua Wu1,
  2. Jihong Liu2,
  3. Jing Wang3,
  4. Li Wang4,
  5. Zhongqiu Lin5,
  6. Xiaobin Wang6,
  7. Jianqing Zhu7,
  8. Beihua Kong8,
  9. Junwei Fei9,
  10. Ying Tang10,
  11. Bairong Xia11,
  12. Zhiqing Liang12,
  13. Ke Wang13,
  14. Yi Huang14,
  15. Hong Zheng15,
  16. An Lin16,
  17. Kui Jiang17,
  18. Wei Wang18,
  19. Xin Wang19 and
  20. Ge Lou20
  1. 1Fudan University Shanghai Cancer Center, Shanghai, China
  2. 2Sun Yat-sen University Cancer Center, Guangzhou, China
  3. 3Hunan Cancer Hospital, Changsha, China
  4. 4Henan Cancer Hospital, Zhengzhou, China
  5. 5Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
  6. 6Liaoning Cancer Hospital and Institute, Shenyang, China
  7. 7Zhejiang Cancer Hospital, Hangzhou, China
  8. 8Qilu Hospital of Shandong University, Jinan, China
  9. 9The First Hospital of Jilin University, Changchun, China
  10. 10Chongqing University Cancer Hospital, Chongqing, China
  11. 11Anhui Provincial Cancer Hospital, Hefei, China
  12. 12The Southwest Hospital of AMU, Chongqing, China
  13. 13Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
  14. 14Hubei Cancer Hospital, Wuhan, China
  15. 15Beijing Cancer Hospital, Beijing, China
  16. 16Fujian Provincial Cancer Hospital, Fuzhou, China
  17. 17The Second Hospital of Dalian Medical University, Dalian, China
  18. 18The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
  19. 19Zhongshan Hospital Xiamen University, Xiamen, China
  20. 20Harbin Medical University Cancer Hospital, Harbin, China


Introduction/Background Maintenance therapy, particularly with Poly-ADP-ribose polymerase (PARP) inhibitors, is recommended to extend platinum-related benefits in ovarian cancer (OC). Senaparib, a potent and selective PARP inhibitor, was investigated in the FLAMES phase 3 trial to confirm its efficacy and safety as first-line (1L) maintenance therapy for Chinese patients with newly diagnosed advanced OC.

Methodology In this double-blind, placebo-controlled trial, 404 eligible patients with newly diagnosed FIGO stage III-IV, high-grade serous, or endometrioid OC, who completed 1L platinum-based chemotherapy with complete (CR) or partial response (PR), were randomized (2:1) to receive senaparib or placebo at 100 mg/day orally. Stratification considered CR/PR and BRCA (breast cancer susceptibility gene) mutation status. The primary endpoint was progression-free survival (PFS), assessed by blinded independent central review (BICR) using RECIST v1.1.

Results As of March 16, 2023, 270 patients received senaparib, and 133 received placebo, with a median follow-up duration of 22.3 months. Senaparib significantly improved PFS over placebo (HR 0.43, 95% CI 0.32–0.58, P < 0.0001), regardless of BRCA status (HR 0.43, P < 0.01). Secondary endpoints, supported by subgroup and investigator assessment, consistently reinforced the primary analyses. The most common adverse events (AEs) were anaemia (81%), neutropenia 76%), leukopenia (75%), and thrombocytopenia (70%) in the senaparib arm; and neutropenia (32%), leukopenia (29%), hypertriglyceridaemia (26%), and transaminase increased (26%) in the placebo arm. AEs led to dose reduction and discontinuation were 63.3% vs. 6.0% and 4.4% vs. 0% in senaparib arm and placebo arm, respectively. No MDS and fatal events reported.

Conclusion First-line maintenance Senaparib significantly reduced the risk of progression or death in advanced OC patients, irrespective of BRCA mutation status. Senaparib demonstrated favorable safety profiles, no additional safety signals were identified.

Disclosures All authors declared no conflicts of interest.

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