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AKEEGA® (niraparib and abiraterone acetate)

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AKEEGA - AMPLITUDE Study

Last Updated: 08/21/2024

SUMMARY

AMPLITUDE (NCT04497844) is an ongoing, phase 3, randomized, double-blind,
placebo-controlled, international, multicenter study evaluating the efficacy and safety of niraparib and abiraterone acetate in a DAT formulation with prednisone plus androgen deprivation therapy (ADT) compared to matching oral placebo/abiraterone acetate in a DAT formulation with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). The primary endpoint is radiographic progression-free survival (rPFS). The study has a planned enrollment of 788 patients from 352 sites in 32 countries.¹^-³
Efficacy and safety results from the AMPLITUDE study have not been published. The planned primary completion date is November 15, 2024.³

CLINICAL DATA

AMPLITUDE Study

Study Design/Methods

The study design is presented in Figure: AMPLITUDE Study Design.

AMPLITUDE Study Design¹^-³

Abbreviations: AA, abiraterone acetate; ADT, androgen deprivation therapy; AML, acute myeloid leukemia; AR, androgen receptor; BRCA, breast cancer susceptibility gene; CT, computed tomography; DAT, dual-action tablet; HRR, homologous recombination repair; mCSPC, metastatic castration-sensitive prostate cancer; MDS, myelodysplastic syndrome; MRI, magnetic resonance imaging; NIRA, niraparib; PARP, poly (adenosine diphosphate-ribose) polymerase; PBO, placebo; PC, prostate cancer; PFS, progression-free survival; PO, orally; R, randomization; rPFS, radiographic PFS.^aUp to maximum of 6 cycles allowed; final dose must be received ≤3 months prior to randomization.^bIf completed ≥1 year before randomization.^cIncluding radiation, prostatectomy, lymph node dissection, and systemic therapies.^dDefined as time from randomization to date of radiographic progression or death, whichever occurs first.^eEvaluation based on adverse events and clinical lab evaluations using National Cancer Institute Common Terminology Criteria for Adverse
Events v5.0.

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 August 2024.

References

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1	Rathkopf DE, Chi KN, Olmos D, et al. AMPLITUDE: a study of niraparib in combination with abiraterone acetate plus prednisone (AAP) versus AAP for the treatment of patients with deleterious germline or somatic homologous recombinant repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). Rapid abstract presentation presented at: American Society of Clinical Oncology Genitourinary (ASCO) Genitourinary Cancers Symposium; February 11-13, 2021; Virtual.
2	Janssen Research & Development, LLC. A study of niraparib in combination with abiraterone acetate and prednisone versus abiraterone acetate and prednisone for the treatment of participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC) (AMPLITUDE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 August 09]. Available from: https://clinicaltrials.gov/show/NCT04497844 NLM Identifier: NCT04497844.
3	Rathkopf DE, Chi KN, Olmos D, et al. AMPLITUDE: niraparib and abiraterone acetate plus prednisone to treat patients with metastatic castration-sensitive prostate cancer and deleterious germline or somatic homologous recombination repair gene alterations. Poster presented at: 23rd Annual Meeting of the Society of Urologic Oncology (SUO); November 30-December 2, 2022; San Diego, CA.