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.
Resources from the same session
5694 - Findings from a new specialist remote Counselling Service for Neuroendocrine Neoplasm (NEN) patients and family members
Presenter: Catherine Bouvier
Session: Poster Display session 2
Resources:
Abstract
4725 - Hematologic malignancies in temozolomide-treated metastatic pancreatic neuroendocrine tumors
Presenter: Nicole Balmaceda
Session: Poster Display session 2
Resources:
Abstract
5842 - Efficacy and toxicity of combination chemotherapy with cyclophosphamide, vincristine and an anthracycline in patients with metastatic extrapulmonary neuroendocrine carcinoma
Presenter: Leonidas Apostolidis
Session: Poster Display session 2
Resources:
Abstract
1543 - An Australian multi-centre experience of the use of peptide receptor radionuclide therapy for bronchial carcinoid tumours.
Presenter: Lisi Lim
Session: Poster Display session 2
Resources:
Abstract
4175 - Extra-pulmonary (EP) high grade (HG) neuroendocrine carcinoma (NEC): real-life outcomes of fifty-eight patients from a Portuguese cancer center.
Presenter: Rita Conde
Session: Poster Display session 2
Resources:
Abstract
3274 - Efficacy of immune check-point inhibitors (ICPi) in large cell neuroendocrine tumors of lung (LCNET)
Presenter: Shira Sherman
Session: Poster Display session 2
Resources:
Abstract
3534 - HORMONET: Study of Tamoxifen in Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression
Presenter: Milton Barros
Session: Poster Display session 2
Resources:
Abstract
2137 - Clinical utility of Metabolic Tumor Volume in Papillary Thyroid Carcinoma
Presenter: Norihiko Takemoto
Session: Poster Display session 2
Resources:
Abstract
3864 - Correlation of thyroglobulin (Tg) oscillations with progression-free survival (PFS) in patients with radioactive iodine-refractory (RAI-R) differentiated thyroid carcinoma (DTC) treated with multikinase inhibitors (MKI).
Presenter: Jorge Hernando Cubero
Session: Poster Display session 2
Resources:
Abstract
2820 - Analytical validation of a thyroid cancer diagnostic method based on the relative quantification of CLDN10, HMGA2 and LAMB3 expression
Presenter: Mateus Barrosfilho
Session: Poster Display session 2
Resources:
Abstract