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Poster Display session 2

4168 - Efficacy and safety of oral poly (ADP-ribose) polymerase inhibitor fluzoparib in patients with BRCA1/2 mutations and platinum sensitive recurrent ovarian cancer

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Ovarian Cancer

Presenters

Ning Li

Citation

Annals of Oncology (2019) 30 (suppl_5): v403-v434. 10.1093/annonc/mdz250

Authors

N. Li1, L. Wu1, Y. zhang2, J. Liu3, Q. Zhou4, J. Zhu5, R. Yin6, L. Wang7, G. Li8, X. Wu9, H. Pan10, S. Yao11, Q. Wu12, K. Gu13, H. zhang14, X. Wan15, R. An16, J. Zou17, Q. wang17

Author affiliations

  • 1 Department Of Gynecologic Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 2 Department Of Gynecologic Oncology, Qilu Hospital of Shandong University, 250002 - shandong/CN
  • 3 Department Of Gynecologic Oncology, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 4 Department Of Gynecologic Oncology, Chongqing Cancer Hospital, 400030 - Chongqing/CN
  • 5 Department Of Gynecologic Oncology, Zhejiang Cancer Hospital, 310022 - Hangzhou/CN
  • 6 Department Of Gynecological Chemotherapy, West China Second University Hospital, Sichuan university, 610066 - Chengdu/CN
  • 7 Department Of Gynecologic Oncology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, 450008 - Zhengzhou/CN
  • 8 Gynaecological Cancer, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, 430023 - Wuhan/CN
  • 9 Department Of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN
  • 10 Gynaecological Cancer, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, 310022 - Zhejiang/CN
  • 11 Department Of Gynecologic Oncology, The First Affiliated Hospital, Sun Yat-sen University, 510060 - Guangzhou/CN
  • 12 Department Of Gynecologic Oncology, Jiangsu Cancer Hospital, 210000 - Nanjing/CN
  • 13 Gynaecological Cancer, The First Affiliated Hospital of Anhui Medical University, 230022 - Hefei/CN
  • 14 Gynaecological Cancer, Fourth Hospital of Hebei Medical University, 050071 - Shijiazhuang/CN
  • 15 Department Of Gynecologic Oncology, Shanghai Frist Maternity And Infant Hospital, 200032 - Shanghai/CN
  • 16 Gynaecological Cancer, The first affiliated hospital of xi'an jiaotong university, 710061 - xian/CN
  • 17 Na, Jiangsu Hengrui Medicine Co. LTD, 201210 - Shanghai/CN

Resources

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Abstract 4168

Background

Fluzoparib is a potent orally administered poly(ADP-ribose) polymerase (PARP) inhibitor. The safety and tolerability of fluzoparib has been evaluated in a phase 1 trial (NCT02575651). In this study, we aim to characterize the efficacy and safety of fluzoparib in patients (pts) with germline BRCA1/2 mutations and platinum sensitive recurrent ovarian cancer who had received ≥2 prior lines of chemotherapy.

Methods

This was an open-label, multi-centre, phase 2 study of oral fluzoparib in pts with recurrent ovarian cancer. Adult pts (≥18 years) with germline BRCA1 or BRCA2 mutations and platinum-sensitive recurrent high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with two or more previous platinum-based chemotherapy regimens were enrolled. Patients were treated with fluzoparib capsule at 150 mg orally twice daily up to disease progression or intolerable toxicity. The primary endpoint was objective response rate (ORR) per RECIST 1.1.

Results

From April 4 2018 to March 21 2019, 113 pts at Chinese national-wide 26 sites were received the fluzoparib. At the data cutoff date (April 15, 2019), 103 pts were efficacy evaluable (follow-up ≥8 weeks). The ORR and disease control rate (DCR) were 64.1% (66/103) and 95.1% (98/103), respectively. Complete response (CR) was observed in 9 pts (8.7%). Median duration of response (DOR) and progression free survival (PFS) have not yet been reached. Any grade treatment-related AEs (TRAEs) occurred in 108 patients (95.6%). The most common (≥20%) TRAE were nausea (55.8%), fatigue (47.8%), white blood cell count decreased (44.2%), anemia or decreased hemoglobin (42.5%), neutrophil count decreased (31.9%), decreased appetite (30.1%), thrombocytopenia (29.1%), and vomiting (23.9%). The most common grade ≥3 TRAE was anemia/hemoglobin decreased. Treatment-emergent AEs led to treatment interruption and dose reduction in 31.0% and 21.1% of patients, respectively.

Conclusions

Fluzoparib demonstrated promising antitumor activity and acceptable safety in patients with advanced BRCA1/2-mutated ovarian cancer. And this is the first report of a PARP inhibitor in Chinese patients with BRCA1/2 mutations and recurrent ovarian cancer.

Clinical trial identification

NCT03509636.

Editorial acknowledgement

Legal entity responsible for the study

Jiangsu Hengrui Medicine Co. LTD, China.

Funding

Jiangsu Hengrui Medicine Co. LTD.

Disclosure

J. Zou: Shareholder / Stockholder / Stock options: Jiangsu Hengrui Medicine Co. LTD. Q. wang: Shareholder / Stockholder / Stock options: Jiangsu Hengrui Medicine Co. LTD. All other authors have declared no conflicts of interest.

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