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Association details:
| Biomarker: | BRCA2 mutation |
|---|---|
| Cancer: | Prostate Cancer |
| Drug: | Zejula (niraparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
09/07/2023
Excerpt:
Prostate Cancer: SYSTEMIC THERAPY FOR M1 CRPC: ADENOCARCINOMA...Useful in certain circumstances…Niraparib/abiraterone for BRCA mutation…
Secondary therapy:
abiraterone acetate
Source:
Title:
258MO - Niraparib plus abiraterone acetate plus prednisone (NIRA+AAP) as first-line treatment in patients with BRCA+ metastatic castration-resistant prostate cancer (mCRPC): Second interim analysis in the Asian subgroup of the MAGNITUDE study
Published date:
11/27/2023
Excerpt:
In the BRCA+ cohort, improvement in rPFS by BICR was observed with NIRA+AAP (N = 17) vs. PBO+AAP (N = 19), with 71% reduced risk of progression or death (HR, 0.29, 95% CI, 0.11, 0.77)...Longer follow-up of the Asian subgroup confirms initial observations of a benefit from NIRA+AAP in BRCA+ mCRPC pts, which is consistent with the overall MAGNITUDE study results.
Secondary therapy:
abiraterone acetate + prednisone
Trial ID:
Source:
Title:
Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial
Published date:
07/01/2023
Excerpt:
At IA2 with 24.8 months of median follow-up in the BRCA1/2 subgroup, niraparib plus AAP significantly prolonged radiographic progression-free survival
Secondary therapy:
abiraterone acetate
DOI:
https://doi.org/10.1016/j.annonc.2023.06.009
Trial ID:
Source:
Title:
Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer
Published date:
03/23/2023
Excerpt:
Median rPFS in the BRCA1/2 subgroup was significantly longer in the niraparib + AAP group compared with the placebo + AAP group (16.6 v 10.9 months; hazard ratio [HR], 0.53; 95% CI, 0.36 to 0.79; P = .001)….Combination treatment with niraparib + AAP significantly lengthened rPFS in patients with HRR+ mCRPC compared with standard-of-care AAP.
Secondary therapy:
abiraterone acetate
DOI:
10.1200/JCO.22.01649
Trial ID:
Source:
Title:
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Published date:
10/19/2019
Excerpt:
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received prior taxane chemotherapy and androgen receptor (AR)-targeted therapy.
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...
Source:
Title:
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies (Galahad)
Excerpt:
...Biomarker-positive by at least one of the following criteria: (a) Biallelic deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing)...ORR of soft tissue disease with no evidence of bone progression in participants with either biallelic Breast Cancer gene 1 (BRCA1) or Breast Cancer gene 2 (BRCA2) or germline BRCA...
Trial ID:
Source:
Title:
High prevalence and heterogeneity of emergence of BRCA reversion mutations at progression on niraparib treatment in BRCA-mutant metastatic castration-resistant prostate cancer (mCRPC) patients
Published date:
03/09/2022
Excerpt:
Patients with reversion mutations showed better composite response (defined as ORR by RECIST 1.1, or CTC conversion to <5/7.5 mL blood, or ≥50% decline in prostate specific antigen) (74.2% vs 25.8%, p=0.01) and longer duration on treatment (median 6.9 vs 3.7 mo, p<0.05) compared to those without or low reversions. Additionally, patients with reversions trended to have longer median radiographic progression-free survival compared to those without or low reversions (8.1 vs 5.5 mo, p=0.12). In conclusion, the high prevalence of patients with BRCA reversion mutations and the displayed longer benefit from niraparib...
Source:
Title:
Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial
Published date:
02/04/2022
Excerpt:
At final analysis, with a median follow-up of 10·0 months (IQR 6·6–13·3), the objective response rate in the measurable BRCA cohort (n=76) was 34·2% (95% CI 23·7–46·0)….Niraparib is tolerable and shows anti-tumour activity in heavily pretreated patients with metastatic castration-resistant prostate cancer and DRDs, particularly in those with BRCA alterations.
DOI:
https://doi.org/10.1016/S1470-2045(21)00757-9
Trial ID:
Source:
Title:
Niraparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): Correlative measures of tumor response in phase II GALAHAD study.
Published date:
02/13/2020
Excerpt:
Pts with (HRR biomarker [BM]+; ATM, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, HDAC2, PALB2)...NIRA + AAP significantly improved rPFS by BICR in the BRCA1/2 subgroup and in all HRR BM+ pts...NIRA + AAP improves rPFS and other clinically relevant outcomes in pts with mCRPC and alterations in HRR associated genes.
Trial ID:
Source:
Title:
PD04-02: Using genomic and transcriptomic properties to determine androgen response in Ductal Prostate Cancers and determine efficacy of Poly(ADP-ribose) polymerase inhibitors with androgen signalling inhibitors therapy in vitro
Published date:
03/31/2023
Excerpt:
Validated BRCA2 heterozygous mutant (201.1A-Cx)...patient-derived DAC organoid models were treated with PARPi, enzalutamide and the combination of PARPi + enzalutamide…. Niraparib + Enzalutamide significantly reduced organoid viability of BRCA2 heterozygous mutant (201.1A-Cx) and HR proficient (287R) cells compared to control, Niraparib or Enzalutamide alone. Moreover, PARPi and ARSI were synergistic in these DAC models.
Secondary therapy:
enzalutamide capsule
