SUMMARY

• In the population pharmacokinetics (PK) analysis of niraparib/abiraterone acetate, no clinically significant effect of age on the PK of niraparib/abiraterone acetate has been observed.¹
• MAGNITUDE is an ongoing, phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of AKEEGA with prednisone compared to placebo/abiraterone acetate with prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations, including BRCA1/2.²
  • Among 225 patients with BRCA1/2 alterations, the median age was 67 years (range, 45-100) in patients receiving niraparib/AAP and 68 years (range, 43-88) in patients receiving placebo/AAP.

IN-VITRO/NONCLINICAL AND CLINICAL DATA

Pharmacokinetic Properties

• In the population PK analysis of AKEEGA, no clinically significant effects on the PK of niraparib and abiraterone acetate has been observed based on age (45-90 years for niraparib and 43-90 years for abiraterone acetate).¹

MAGNITUDE Study

• Chi et al (2023)² conducted a second interim analysis of the ongoing, phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of AKEEGA with prednisone compared to placebo/AAP in patients with mCRPC and HRR gene alterations, including BRCA1/2. The summary below is limited to information from the second interim analysis of the MAGNITUDE study.

Results

Patient Characteristics

• Among 225 patients with BRCA1/2 alterations, the median age was 67 years (range, 45100) in patients receiving niraparib/AAP and 68 years (range, 43-88) in patients receiving placebo/AAP.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 11 June 2024. Summarized in this response are relevant data pertaining to this topic in patients with prostate cancer.