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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | Ovarian Cancer |
| Drug: | Partruvix (pamiparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
China NMPA Approves PARP Inhibitor Pamiparib for Patients with Previously Treated Advanced Ovarian Cancer
Published date:
05/07/2021
Excerpt:
BeiGene...announced that its PARP inhibitor pamiparib has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.
Trial ID:
Source:
Title:
Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China
Published date:
07/27/2020
Excerpt:
BeiGene...announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) of pamiparib, BeiGene’s investigational inhibitor of PARP1 and PARP2, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy....t is supported by clinical results from the pivotal Phase 2 portion of the Phase 1/2 trial...
Source:
Title:
Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
Excerpt:
...2) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation 4....
Trial ID:
Source:
Title:
Pamiparib in Fusion Positive, Reversion Negative High Grade Serous Ovarian Cancer or Carcinosarcoma With BRCA1/2 Gene Mutations If Progression on Substrate Poly ADP Ribose Polymerase Inhibitbor (PARPI) or Chemotherapy
Excerpt:
...Patients with a histopathological diagnosis of HGSC or carcinosarcoma of the ovary (including primary peritoneal cancers and fallopian tube cancers) as defined by histological diagnosis and immunohistochemistry (IHC) and with a germline or somatic BRCA1/2 mutation:...
Trial ID:
More C2 evidence
Source:
Title:
A Phase II, Signal-Seeking Trial of the Clinical Benefit Rate Associated with Pamiparib in Subjects with Germline or Somatic BRCA1/2 High Grade Serous Ovarian Cancer or carcinosarcoma who have progressed on P-gp substrate chemotherapy or PARP inhibitors with the Presence of an ABCB1 Fusion and the Absence of a BRCA1/2 Reversion
Excerpt:
...Patients with a histopathological diagnosis of HGSC or carcinosarcoma of the ovary (including primary peritoneal cancers and fallopian tube cancers) as defined by histological diagnosis and immunohistochemistry (IHC) and with a germline or somatic BRCA1/2 mutation:...
Trial ID:
Less C2 evidence
Source:
Title:
Pamiparib Monotherapy for Patients With Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated With at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study
Published date:
11/29/2021
Excerpt:
In PSOC patients, 8 achieved a complete response (CR) and 45 achieved a partial response (PR); ORR was 64.6% (95% CI, 53.3-74.9). In PROC patients, 6 achieved a PR; ORR was 31.6% (95% CI, 12.6-56.6). Pamiparib 60 mg BID showed antitumor activity with durable responses in patients with PSOC or PROC with gBRCAmut...
DOI:
10.1158/1078-0432.CCR-21-1186
Source:
Title:
820P - Phase II study of pamiparib in Chinese patients (pts) with advanced ovarian cancer (aOC)
Published date:
09/14/2020
Excerpt:
...113 pts (cohort 1, n=90; cohort 2, n=23) were enrolled. Median age was 54 yr (range: 34-79), 25.6% (n=29) of pts had received ≥4 prior systemic chemotherapy lines, and 54.0% (n=61) of pts had an ECOG score of 1 at study entry. At data cutoff, median follow-up was 12.2 mo (range: 0.2-21.5). Across both cohorts, pamiparib showed preliminary antitumor activity (Table). In cohort 1, confirmed ORRIRC was 64.6%, median DoR was 14.5 mo (95% CI, 11.1-NE), progression-free survival (PFS) was 15.2 mo (95% CI, 10.35-NE), and median overall survival (OS) was not yet mature...Promising antitumor activity was observed in pts with platinum-sensitive/resistant aOC. Pamiparib was generally tolerated...
Trial ID:
Source:
Title:
Abstract CT050: A phase I dose escalation study of BGB-290 in Chinese subjects with advanced ovarian, fallopian, and primary peritoneal, or advanced triple-negative breast cancer
Published date:
04/14/2018
Excerpt:
Preliminary activity showed 2 confirmed PRs (BRCA+=1) and 6 SD (BRCA+=4) in HGOC pts (all platinum-resistant/refractory); median duration of treatment is 133 days (range: 8–260) with 5 pts still on treatment. Best response in the 5 TNBC pts was PD (BRCA+=1).
DOI:
10.1158/1538-7445.AM2018-CT050
Trial ID:
