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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

AKEEGA® (niraparib and abiraterone acetate)

Medical Information

AKEEGA - Concomitant Use with Chemotherapy

Last Updated: 07/01/2025

Summary

In the phase 3 MAGNITUDE study evaluating the efficacy and safety of AKEEGA with prednisone compared to placebo/abiraterone acetate with prednisone as first-line (L1) therapy in metastatic castration-resistant prostate cancer (mCRPC) for patients with certain homologous recombination repair (HRR) mutations, including BRCA1/2, patients who received taxane-based chemotherapy in the mCRPC setting were excluded.¹^-⁵ Additionally, concomitant chemotherapy use was prohibited during the study.³

CLINICAL DATA

No clinical studies have been identified evaluating the use of AKEEGA with concurrent chemotherapy for the treatment of patients with prostate cancer.

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 01 July 2025. Summarized in this response are relevant data pertaining to this topic in patients with prostate cancer.

References

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1	Janssen Research & Development, LLC. A study of niraparib in combination with abiraterone acetate and prednisone versus abiraterone acetate and prednisone for treatment of participants with metastatic prostate cancer (MAGNITUDE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 June 11]. Available from: https://clinicaltrials.gov/show/NCT03748641 NLM Identifier: NCT03748641.
2	Chi KN, Rathkopf D, Smith MR, et al. Niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer. J Clin Oncol. 2023;41(18):3339-3351.
3	Chi KN, Rathkopf D, Smith MR, et al. Protocol for: Niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer. J Clin Oncol. 2023;41(18):3339-3351.
4	Chi KN, Sandhu S, Smith MR, et al. 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. Ann Oncol. 2023;34(9):772-782.
5	Chi KN, Castro E, Attard G, et al. Niraparib and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: final overall survival analysis for the phase 3 MAGNITUDE trial. [published online ahead of print May 05, 2025]. Eur Urol Oncol. doi:10.1016/j.euo.2025.04.012.

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