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PO012LBA/#1511  Flames: randomized phase 3 trial of maintenance senaparib in patients with newly diagnosed advanced ovarian cancer
  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,
  20. Ge Lou20 and
  21. Hongming Pan21
  1. 1Fudan University Shanghai Cancer Center, Department of Gynecologic Oncology, Shanghai, China
  2. 2Sun Yat-sen University Cancer Center, Gynecologic Oncology, Guangzhou, China
  3. 3Liaoning Cancer Hospital & Institute, Department of Gynecologic Oncology, Shenyang, China
  4. 4Hu’nan Cancer Hospital, Department of Gynecologic Oncology, Changsha, China
  5. 5Henan Cancer Hospital, Department of Gynecologic Oncology, Zhengzhou, China
  6. 6Zhejiang Cancer Hospital, Department Of Gynecologic Oncology, Hangzhou, China
  7. 7Qilu hospital of Shandong University, Obstetrics & Gynecology, Jinan, Shandong province, China
  8. 8The First Hospital of Jilin University, Department of Gynecologic Oncology, Changchun, China
  9. 9Cancer Hospital Affiliated to Chongqing University, Gynaecological Cancer, Chongqing, China
  10. 10Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital, Department of Gynecologic Oncology, Hefei, China
  11. 11The Southwest Hospital of AMU, Department of Gynecologic Oncology, Chongqing, China
  12. 12Tianjin Cancer Hospital, Department of Gynecologic Oncology, Tianjin, China
  13. 13Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Department of Gynecologic Oncology, Guangzhou, China
  14. 14Hubei Cancer Hospital, Department of Gynecologic Oncology, Wuhan, China
  15. 15Peking University Cancer Hospital & Institute, Gynecologic Oncology, Beijing, China
  16. 16Fujian Cancer Hospital, Gynecologic Oncology, Fuzhou, China
  17. 17The Second Hospital of Dalian Medical University, Department of Oncology, Dalian, China
  18. 18The First Affiliated Hospital of Guangzhou Medical University, Department of Obstetrics and Gynaecology, Guangzhou, China
  19. 19Zhongshan Hospital Xiamen University, Department of Gynecologic Oncology, Xiamen, China
  20. 20Harbin Medical University Cancer Hospital, Gynecological Oncology, Harbin, China
  21. 21Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Department of Gynecologic Oncology, Hangzhou, China


Introduction FLAMES is a randomized, double-blind, placebo-controlled, phase 3 trial to evaluate efficacy and safety of senaparib as first line (1L) maintenance therapy in patients with newly diagnosed advanced ovarian cancer (OC).

Methods Chinese patients with newly diagnosed, FIGO stage III-IV, high-grade serous or endometrioid OC who had achieved complete response (CR) or partial response (PR) to 1L platinum-based chemotherapy were randomized (2:1) to receive senaparib or placebo. Primary endpoint was progression-free survival (PFS ) evaluated by BICR according to RECIST v1.1. A prespecified subgroup analysis was performed based on FIGO stage (III vs IV), BRCA mutation (positive vs negative), 1L treatment response (CR vs PR), neoadjuvant chemotherapy (yes vs no) and presence of residual disease after debulking surgery (yes vs no).

Results 404 patients were randomized to receive senaparib vs placebo with a median follow up of 22.4 and 22.2 months, respectively. PFS was significantly increased in senaparib arm (HR 0.43, 95% CI 0.32–0.58, P < 0.0001) over placebo. All subgroup analysis demonstrated consistent treatment benefit ( HR <0.50, P<0.0001, figure 1). Incidence rates of grade ≥3 adverse events (AEs) were 66.3% vs 20.3%, respectively. The most common grade ≥3 AEs were anemia (29.3%) , thrombocytopenia (26.7%), and neutropenia (24.8%) after received senaparib. No new safety signals were identified among all subgroups.

Abstract PO012LBA/#1511 Figure 1
Abstract PO012LBA/#1511 Figure 2

Conclusion/Implications Maintenance senaparib significantly improved PFS regardless of FIGO stage, 1L treatment response, surgical timing and residual disease status versus placebo in patients with newly diagnosed advanced OC.

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