^
Association details:
| Biomarker: | BRCA2 mutation |
|---|---|
| Cancer: | Ovarian Cancer |
| Drug: | AiRuiYi (fluzoparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Fuzuloparib maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer: A multicenter, randomized, double-blind, placebo-controlled, phase III trial
Published date:
03/19/2021
Excerpt:
...patients were randomly assigned to the fuzuloparib (n = 167) or placebo (n = 85). The HR derived from prespecified subgroup analyses showed a consistent trend of benefit in patients with BRCA 1/2 mutation (HR, 0.14, 95% CI, 0.07-0.28)...
Source:
Title:
A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
Excerpt:
...- Confirmed documented BRCA1/2 mutation;...
Trial ID:
Source:
Title:
An Open-label, Multicenter, Single-arm, Phase II Study of Fluzoparib in Patients with Germline BRCA1/2 Mutation and Platinum-sensitive Recurrent Ovarian Cancer
Published date:
03/09/2021
Excerpt:
Fluzoparib demonstrated promising antitumor activity and acceptable safety profile in germline BRCA1/2-mutated, platinum-sensitive relapsed ovarian cancer. Thus, fluzoparib might be a novel treatment option for this population
DOI:
10.1158/1078-0432.CCR-20-3546
Trial ID:
Source:
Title:
Phase I dose-escalation and expansion study of PARP inhibitor, fluzoparib (SHR3162), in patients with advanced solid tumors
Published date:
04/29/2020
Excerpt:
In patients with germline BC susceptibility gene mutation (gBRCA Mut) (11/43 OC; 2/16 BC), mPFS was 8.9 months for OC (range, 1.0-23.2; 95% CI, 1.0-16.8) and 14 and 28 months for BC (those two patients both also had somaticBRCA Mut)….Efficacy in patients with gBRCA1/2Mut gBRCA1/2Mut was tested in 43 patients with OC and 16 patients with BC; 11 in 43 OC (7 gBRCA1Mut, 2 gBRCA2Mut, 2 both gBRCA1/2Mut) and 2 in 16 BC (one gBRCA2Mut, one both gBRCA1/2Mut) had a gBRCAMut.
DOI:
10.21147/j.issn.1000-9604.2020.03.08
Source:
Title:
341 - Efficacy and safety of oral poly (ADP-ribose) polymerase inhibitor fluzoparib in patients with BRCA1/2 mutations and recurrent ovarian cancer
Published date:
03/29/2020
Excerpt:
This was an open-label, multicenter, phase 2 study of oral fluzoparib in Chinese patients with recurrent ovarian cancer. Adult patents (≥18 years) with germline BRCA1 or BRCA2 mutations...Median duration of response was 10.1 months (95% CI 7.23–NC). ..Fluzoparib had demonstrated promising antitumor activity and an acceptable safety profile in patients with recurrent BRCA1- or BRCA2-mutated ovarian cancer.
Trial ID:
Source:
Title:
4168 - Efficacy and safety of oral poly (ADP-ribose) polymerase inhibitor fluzoparib in patients with BRCA1/2 mutations and platinum sensitive recurrent ovarian cancer
Published date:
09/29/2019
Excerpt:
The ORR and disease control rate (DCR) were 64.1% (66/103) and 95.1% (98/103), respectively…Fluzoparib demonstrated promising antitumor activity and acceptable safety in patients with advanced BRCA1/2-mutated ovarian cancer.
Trial ID:
