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AKEEGA® (niraparib and abiraterone acetate)

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AKEEGA - Concomitant Use with Chemotherapy

Last Updated: 07/10/2024

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 09 July 2024. 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 2024 July 09]. 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 K, Castro E, Attard G, et al. Niraparib (NIRA) with abiraterone acetate plus prednisone (AAP) as first-line (1L) therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: three-year update and final analysis (FA) of MAGNITUDE. Oral presentation presented at: European Society of Medical Oncology (ESMO) Congress; October 20-24, 2023; Madrid, Spain.