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Association details:
Biomarker:HRD
Cancer:Prostate Cancer
Drug:Zejula (niraparib) (PARP inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
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:
rPFS was also prolonged in the total HRR+ population [HR = 0.76 (95% CI 0.60-0.97); nominal P = 0.0280; median follow-up 26.8 months].
Secondary therapy:
abiraterone acetate
DOI:
https://doi.org/10.1016/j.annonc.2023.06.009
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Impact of run-in treatment with abiraterone acetate and prednisone (AAP) in the MAGNITUDE study of niraparib (NIRA) and AAP in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations.

Published date:
02/13/2023
Excerpt:
423 pts with mCRPC and HRR gene alterations were randomized 1:1 to receive NIRA/AAP...Pts receiving AAP ≤2 mos had similar benefit (radiographic progression-free survival [rPFS] hazard ratio [HR], 0.69 [95% confidence interval [CI], 0.36-1.30]; time to cytotoxic chemotherapy [TCC] HR, 0.52 [95% CI, 0.24-1.11]; time to symptomatic progression [TSP] HR, 0.32 [95% CI, 0.13-0.79]; Table) to pts not receiving any prior AAP.
DOI:
10.1200/JCO.2023.41.6_suppl.172
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

158MO - Niraparib with abiraterone acetate and prednisone (NIRA+AAP) as first-line therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR+) gene alterations: Asian subgroup analysis of the MAGNITUDE study

Published date:
11/28/2022
Excerpt:
Improvement in rPFS by BICR was observed with NIRA+AAP vs PBO+AAP…Data from this Asian subgroup analysis of the MAGNITUDE study are aligned with the global results and support the benefit of NIRA+AAP in HRR+ mCRPC...
Secondary therapy:
abiraterone acetate
Trial ID:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Peritoneal Cancer)
New
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.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

MP27-17 NIRAPARIB WITH ABIRATERONE ACETATE AND PREDNISONE FOR METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: RESULTS FROM THE PHASE 2 QUEST STUDY

Published date:
04/09/2022
Excerpt:
CRR was 52.2% (90% CI, 33.5‒70.4). ORR was 50% (5/10 pts; 90% CI, 9.0–40.4); duration of response was 4.73 mos (range 3.7‒8.2)….In pts with mCRPC and HRD alterations and prior AR-targeted therapy, NIRA+AAP has promising efficacy and a manageable safety profile.
Secondary therapy:
abiraterone acetate
DOI:
https://doi.org/10.1097/JU.0000000000002570.17
Trial ID: