In patients with
BRCA2 m mCSPC

54% reduction

in risk of radiographic
progression or death vs
standard of care (SoC*)
HR, 0.46 (95% CI, 0.32-0.66)1

Efficacy
59% improvement

in time to symptomatic progression (TSP) vs SoC*
(interim analysis)
HR, 0.41 (95% CI, 0.26-0.65)1

Efficacy
87% of patients

remained on AKEEGA® without discontinuing due to adverse reactions1

Safety

AMPLITUDE: A phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluated AKEEGA® + P (n=348) vs placebo + AAP (n=348) in patients with HRR mutations. Of these patients, 323 had BRCA2  mutations (162 and 161 in the AKEEGA® + P and placebo + AAP treatment arms, respectively). All patients received prednisone 5 mg daily and were required to have received treatment with ADT (medical or surgical) for >14 days prior to randomization. The primary endpoint was investigator-assessed radiographic progression-free survival. Secondary endpoints included time to symptomatic progression, overall survival, and safety.1

Trial Design

The most common adverse reactions that occurred in >20% of patients with BRCA2 m mCSPC receiving AKEEGA® and with a ≥5% difference vs SoC were hypertension (51%), musculoskeletal pain (45%), constipation (41%), fatigue (39%), nausea (30%), respiratory tract infection (23%), and arrhythmia (23%).1

AKEEGA® studies included over 600 patients with BRCA mutations1,2

*SoC = abiraterone acetate + prednisone.1

AAP, abiraterone acetate + prednisone; BRCA2 m, BRCA2 gene-mutated; CI, confidence interval; FDA, U.S. Food and Drug Administration; HR, hazard ratio; HRR, homologous recombination repair; mCSPC, metastatic castration-sensitive prostate cancer; P, prednisone; SoC, standard of care.


References:

  1. AKEEGA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. Attard G, Agarwal N, Graff JN, et al. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025. doi:10.1038/s41591-025-03961-8