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AKEEGA® (niraparib and abiraterone acetate)

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AKEEGA - Second Progression-Free Survival (PFS2)

Last Updated: 06/27/2024

SUMMARY

In MAGNITUDE, the ongoing, phase 3 study evaluating the efficacy and safety of AKEEGA plus 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, progression-free survival on first subsequent therapy (PFS2) is a prespecified exploratory endpoint.¹^-³ Data on PFS2 have not been published.

CLINICAL DATA

No relevant clinical data have been identified evaluating the effect of AKEEGA on PFS2 in 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 11 June 2024. Summarized in this response are relevant data pertaining to this topic in patients with prostate cancer.

References

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1	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.
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, 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.