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#511 Efficacy and safety of senaparib as maintenance treatment in patients with newly diagnosed advanced ovarian cancer (FLAMES study): a randomized, double-blind, placebo-controlled, phase 3 trial
  1. Xiaohua Wu1,
  2. Jihong Liu2,
  3. Xiaobin Wang3,
  4. Jing Wang4,
  5. Li Wang5,
  6. Jianqing Zhu6,
  7. Beihua Kong7,
  8. Junwei Fei8,
  9. Ying Tang9,
  10. Bairong Xia10,
  11. Zhiqing Liang11,
  12. Ke Wang12,
  13. Zhongqiu Lin13,
  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, Guangzhou, China
  3. 3Cancer Center, Shenyang, China
  4. 4Liaoning Cancer Hospital & Institute, Changsha, China
  5. 5Hunan Cancer Hospital, Zhengzhou, China
  6. 6Henan Cancer Hospital, Hangzhou, China
  7. 7Zhejiang Cancer Hospital, Jinan, China
  8. 8Qilu Hospital of Shandong University, Changchun, China
  9. 9The First Hospital of Jilin University, Chongqing, China
  10. 10Chongqing University Cancer Hospital, Hefei, China
  11. 11Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital, Chongqing, China
  12. 12South West Hospital, Tianjin, China
  13. 13Third Military Medical University, Guangzhou, China
  14. 14Tianjin Medical University Cancer Institute & Hospital, Wuhan, China
  15. 15Sun Yat-sen Memorial Hospital, Beijing, China
  16. 16Sun Yat-sen University, Fuzhou, China
  17. 17Hubei Cancer Hospital, Dalian, China
  18. 18Beijing Cancer Hospital, Guangzhou, China
  19. 19Fujian Provincial Cancer Hospital, Xiamen, China
  20. 20The Second Hospital of Dalian Medical University, Harbin, China


Introduction/Background Ovarian cancer (OC) is the most lethal gynecologic cancers. The first-line (1L) treatment of newly diagnosed advanced OC is surgery and platinum-based chemotherapy, up to 85% of patients (pts) may experience a recurrence. Poly ADP-ribose polymers (PARP) inhibitors are recommended as maintenance therapy to prolong the benefit of platinum. Senaparib (IMP4297) is a novel, high potency PARP inhibitor. The phase 3 study FLAMES is to confirm the efficacy and safety of Senaparib as 1L maintenance therapy in Chinese pts with newly diagnosed advanced OC.

Methodology Eligible pts are those with high-grade serous or endometrioid tumors staged FIGO (International Federation of Gynecology and Obstetrics) III or IV, who completed 1L platinum-based chemotherapy with complete response (CR) or partial response (PR). Pts were randomized 2:1 to receive senaparib (Sena) or placebo (PBO) 100 mg/day orally, stratified by CR/PR and breast cancer susceptibility gene (BRCA) mutation positive/negative. Primary endpoint was progression-free survival (PFS ) evaluated according to RECIST v1.1.

Results As of Mar of 16 ,2023, 404 pts have been randomized. 268 and 135 pts received Sena and PBO with median follow-up x months. Sena significantly improved PFS (mPFS x vs x mo; HR 0.xx, p<0.01) over placebo. All subgroup analysis demonstrated consistent benefit. Incidence rates of grade ≥3 treatment emergent adverse events (AEs) were x% vs x%, AEs leading to dose reduction and discontinuation were x% vs x% and x% vs x%. No AE leading to death. The most common grade ≥3 TEAEs were anemia (x%) , thrombocytopenia (x%), and neutropenia (x%).

Conclusion Pts who received Sena had a meaningful and significant improvement in PFS compared to those who received PBO and the PFS is much longer than other PARP inhibitors, regardless of biomarker status. Sena was well tolerated, no new safety signals were identified.

Disclosures All of the authors have no conflict of interest to report.

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