^
Association details:
| Biomarker: | HRD |
|---|---|
| Cancer: | Ovarian Cancer |
| Drug: | Zejula (niraparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated:...for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:...a deleterious or suspected deleterious BRCA mutation, or...genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.
Test:
Source:
Title:
Poly(ADP-Ribose) Polymerase Inhibitors in the Management of Ovarian Cancer: ASCO Guideline Rapid Recommendation Update
Published date:
09/23/2022
Excerpt:
Newly Diagnosed Ovarian Cancer….Recommendation 2.1….For those who are HRD positive, determined using FDA-approved companion diagnostic tests, rucaparib and niraparib are options.
DOI:
10.1200/JCO.22.01934
Source:
Title:
32 - Time to first subsequent therapy (TFST) and progression-free survival 2 (PFS2) from the phase 3 randomized, double-blind PRIMA/ENGOT-OV26/GOG-3012 study in patients with newly diagnosed ovarian cancer
Published date:
03/29/2020
Excerpt:
In patients with homologous recombination-proficient tumors, the median TFST was 3.7 months longer in patients receiving niraparib than in patients receiving placebo (HR = 0.64, 95% CI 0.46–0.90, P < 0.0105). PFS2 data show point estimates HR < 1, as shown in Table 1 (20% data maturity in overall population)....Preliminary data on TFST and PFS2 were supportive of a clinical benefit of niraparib therapy in a broad population of patients with ovarian cancer following response to first-line chemotherapy.
Source:
Title:
Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer
Published date:
12/19/2019
Excerpt:
The median duration of progression-free survival in patients with homologous-recombination deficiency was 21.9 months with niraparib and 10.4 months with placebo (hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001)...Within the population with homologous-recombination deficiency, the median duration of progression-free survival was 22.1 months in the niraparib group and 10.9 months in the placebo group (hazard ratio, 0.40; 95% CI, 0.27 to 0.62) in the subgroup with BRCA mutations and 19.6 months and 8.2 months, respectively (hazard ratio, 0.50; 95% CI, 0.31 to 0.83), in the subgroup without BRCA mutations....
DOI:
10.1056/NEJMoa1910962
Trial ID:
Source:
Title:
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer
Excerpt:
Patients in the niraparib group had a significantly longer median duration of progression-free survival than did those in the placebo group, including 21.0 vs. 5.5 months in the gBRCA cohort (hazard ratio, 0.27; 95% confidence interval [CI], 0.17 to 0.41), as compared with 12.9 months vs. 3.8 months in the non-gBRCA cohort for patients who had tumors with homologous recombination deficiency (HRD) (hazard ratio, 0.38; 95% CI, 0.24 to 0.59)...
DOI:
10.1056/NEJMoa1611310
Trial ID:
Source:
Title:
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Excerpt:
...Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)`PFS was defined as the time between randomization and disease progression or death from any cause. ...
Trial ID:
Source:
Title:
A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Excerpt:
...- Participants must have high-grade serous or endometrioid or high-grade predominantly serous or endometrioid histology, regardless of homologous recombination deficiency (HRD) or germline breast cancer susceptibility gene (gBRCA) mutation status....
Trial ID:
More C2 evidence
Source:
Title:
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Excerpt:
...Duration of Response (DoR)`ORR by HRD Status and Breast Cancer Gene (BRCA) Status`Disease Control Rate (DCR)`Progression Free Survival`Overall Survival`Time to First Subsequent Therapy (TFST)...
Trial ID:
Source:
Title:
PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer
Excerpt:
...Participant who is able to provide tumor slides obtained during cytoreductive surgery for a prospective examination of the homologous recombination deficiency (HRD)....
Trial ID:
Source:
Title:
A Study of Niraparib in Patients With Relapsed Ovarian Cancer
Excerpt:
...Patients must be gBRCA mutation or HRD positive...
Trial ID:
Source:
Title:
A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy
Excerpt:
......
Trial ID:
Source:
Title:
Niraparib in Tumors Metastatic to the CNS
Excerpt:
...- Diagnosis of triple negative breast cancer or ovarian cancer, or any cancer histology with the presence of alteration in BRCA1, BRCA2, PARP metabolism, DNA repair pathways and HRD (homologous recombination deficiency) genes in the metastatic site as described in Section 9.2 using a CLIA-certified assay....
Trial ID:
Source:
Title:
Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer
Excerpt:
...Participants must agree to undergo tumor homologous recombination deficiency/deficient (HRD) testing, and this test result must show that participants have an HRD-positive tumor (defined by the presence of a deleterious or suspected deleterious breast cancer gene (BRCA) mutation or be positive for genomic instability) by the central laboratory selected by the sponsor....
Trial ID:
Source:
Title:
A Study for Post-Marketing Surveillance of Niraparib in the Treatment of Adult Participants for Approved Indications in South Korea
Excerpt:
...Monotherapy treatment of adult participants with recurrent ovarian, fallopian tube or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens with either a) BRCA mutation (irrespective of platinum sensitivity) or b) platinum-sensitive HRD positive....
Trial ID:
Less C2 evidence
Source:
Title:
The efficacy and safety of niraparib for ovarian cancer: a single-center observational study from China
Published date:
05/17/2021
Excerpt:
Twenty-two patients all received niraparib at a bolus of 200 mg/d. Fifty percent of patients with high-grade serous ovarian cancer are HRD-positive....two patients achieved partial response (PR) and one patient achieved stable disease (SD), yielding objective response rate (ORR) of 33.3%...
DOI:
10.1186/s13048-021-00803-2
