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AKEEGA® (niraparib and abiraterone acetate)

Medical Information

Use of AKEEGA with Concurrent Radiotherapy

Last Updated: 07/18/2024

Summary

  • In the phase 3 MAGNITUDE study evaluating the efficacy and safety of AKEEGA with prednisone compared with placebo/abiraterone acetate with prednisone (AAP) 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 were excluded if radiation therapy was administered within 28 days of randomization.1-4
    • During the study, concomitant radiotherapy for tumor progression was prohibited, excluding palliative radiotherapy in select cases after discussion with the sponsor.2
    • Study treatment was discontinued for unequivocal clinical progression, which included the need to initiate radiation therapy for tumor progression as defined within the protocol.

CLINICAL DATA

No clinical studies have been identified evaluating the use of AKEEGA with concurrent radiotherapy 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

1 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.  
2 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.  
3 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.  
4 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.