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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)

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Comparison of AKEEGA with Enzalutamide

Last Updated: 06/24/2024

Summary

No prospective, randomized, head-to-head clinical trials comparing the efficacy and safety of AKEEGA with enzalutamide have been conducted.
ProBio (Prostate-Biomarker, NCT03903835) is an ongoing, phase 3, outcome-adaptive, multiarm, multiple-assignment, randomized, open-label, international biomarker-driven platform study in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC) or first-line (L1) metastatic castration-resistant prostate cancer (mCRPC). Patients will be randomized to receive either standard of care (SOC) or an experimental treatment including abiraterone acetate, AKEEGA, or enzalutamide based on predefined biomarker signatures. The study has a planned enrollment of 750 patients. The efficacy and safety results have not been published.¹^,²

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and DerwentDrug File (and/or other resources, including internal/external databases) was conducted on 18 June 2024. Summarized in this response are relevant data pertaining to this topic in patients with prostate cancer.

References

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1	Karolinska Institutet. ProBio: a biomarker driven study in patients with metastatic prostate cancer (ProBio). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 June 18]. Available from: https://clinicaltrials.gov/study/NCT03903835?term=apalutamide&intr=Niraparib&rank=4. NLM Identifier: NCT03903835.
2	De Laere B, Crippa A, Discacciati A, et al. Clinical trial protocol for ProBio: an outcome-adaptive and randomised multiarm biomarker-driven study in patients with metastatic prostate cancer. Eur Urol Focus. 2022;8:1617-1621.