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AKEEGA®

(niraparib and abiraterone acetate)

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AKEEGA® (niraparib and abiraterone acetate)

Medical Information

AKEEGA - Concomitant Use with Chemotherapy

Last Updated: 01/13/2026

Summary

  • In the phase 3 MAGNITUDE study evaluating the efficacy and safety of AKEEGA with prednisone compared to placebo/abiraterone acetate (AA) 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
  • The phase 3 AMPLITUDE study is an ongoing, randomized, double-blind, placebo-controlled, multicenter, global study evaluating the efficacy and safety of niraparib and AA in a dual-action tablet formulation with prednisone plus androgen deprivation therapy (ADT) compared with matching oral placebo/AA with prednisone (AAP) plus ADT in patients with deleterious germline or somatic HRR gene–altered metastatic castration-sensitive prostate cancer (mCSPC; N=696).6-10

CLINICAL DATA

AMPLITUDE Study

Attard et al (2025)9,10 reported the efficacy and safety results of AKEEGA plus ADT vs placebo/AAP plus ADT in patients with deleterious germline or somatic HRR gene–altered mCSPC (N=696).

Study Design/Methods

  • Phase 3, randomized, double-blind, placebo-controlled, multicenter, global study.
  • The study design is presented in Figure: AMPLITUDE Study Design.
  • All prestudy and concomitant therapies were documented from the time informed consent was obtained until 30 days following the final dose of study medication.11 

AMPLITUDE Study Design6-10

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Abbreviations: AA, abiraterone acetate; AAP, abiraterone acetate plus prednisone; ADT, androgen deprivation therapy; AML, acute myeloid leukemia; ARPI, androgen receptor pathway inhibitor; BRCA, breast cancer susceptibility gene; CT, computed tomography; DAT, dual-action tablet; ECOG PS, Eastern Cooperative Oncology Group performance status; HRR, homologous recombination repair; mCSPC, metastatic castration-sensitive prostate cancer; MDS, myelodysplastic syndrome; MRI, magnetic resonance imaging; NIRA, niraparib; PARPi, poly (adenosine diphosphate-ribose) polymerase inhibitor; PBO, placebo; PC, prostate cancer; PO, orally; QD, once daily; R, randomization; rPFS, radiographic progression-free survival.
aPatients with lymph node-only disease were not eligible. Metastatic disease as documented by CT, MRI, or bone scan.
bFinal dose must be received ≤3 months prior to randomization.
c≤1 course radiation or surgery for symptoms; radiation completed before randomization.
dIf completed ≥1 year before randomization.
eIncluding radiation, prostatectomy, lymph node dissection, and systemic therapies.
fBy investigator. Defined as time from randomization to date of radiographic progression or death, whichever occurred first.
gEvaluation based on adverse events and clinical lab evaluations using National Cancer Institute Common Terminology Criteria for Adverse
Events v5.0.

Results

  • Patient characteristics were well balanced between the 2 groups.
  • Of the 196 patients in the placebo/AAP group who discontinued treatment, at data cutoff, 141 (72%) patients were reported to have received a life-prolonging subsequent treatment for prostate cancer chosen based on the treating physician’s judgment and local approvals, which included chemotherapy in 102 patients (72%) and poly(adenosine diphosphate-ribose) polymerase inhibitor (PARPi) therapy in 47 patients (33%). The subsequent therapies used are presented in Table: Subsequent Therapy (ITT Population).
  • Of the 102 patients treated with chemotherapy, 18 (17.6%) patients received carboplatin or cisplatin, agents that share a similar mechanism of action as PARP inhibitors.
  • Among the 159 patients in the niraparib and abiraterone group who were no longer on trial treatment (158 discontinued and 1 did not initiate therapy), 89 (56%) patients subsequently received a lifeprolonging therapy. Of these, 71 (80%) patients were treated with chemotherapy, and 10 (11%) patients received a PARPi.

Subsequent Therapy (ITT Population)9,10
Patients who discontinued treatment intervention, n (%)
AKEEGA plus prednisone
(n=159)b
Placebo/AAP
(n=196)
Any subsequent prostate cancer therapy (denominator for below)
89
141
Chemotherapyc
71 (79.8)
102 (72.3)
   Docetaxel
59 (83.1)
84 (82.4)
   Cabazitaxel
18 (25.4)
27 (26.5)
   Carboplatin
11 (15.5)
15 (14.7)
   Cisplatin
2 (2.8)
3 (2.9)
   Etoposide
2 (2.8)
4 (3.9)
   Cyclophosphamide
1 (1.4)
3 (2.9)
   Mitoxantrone
1 (1.4)
1 (1.0)
   Imifoplatin
0
1 (1.0)
   Paclitaxel
0
2 (2.0)
ARPId
27 (30.3)
40 (28.4)
PARPie
10 (11.2)
47 (33.3)
Radiopharmaceuticals
8 (9.0)
10 (7.1)
Immunotherapy
2 (2.2)
7 (5.0)
Otherf
7 (7.9)
15 (10.6)
Abbreviations: AAP, abiraterone acetate plus prednisone; ARPI, androgen receptor pathway inhibitor; ITT, intention-to-treat; PARPi, poly(adenosine diphosphateribose) polymerase inhibitor; rPFS, radiographic progression-free survival.
aData reflect all subsequent lines of therapy. Recurrent medications were counted only once per patient. Selected subsequent therapies were those with potential rPFS benefit.bOne randomized patient never received the study treatment.
cThe most common in AKEEGA plus prednisone vs placebo/AAP were as follows: docetaxel (n=59 [83.1%] vs n=84 [82.4%]), cabazitaxel (n=18 [25.4%] vs n=27 [26.5%]), and carboplatin (n=11 [15.5%] vs n=15 [14.7%]).
dThe most common in AKEEGA plus prednisone vs placebo/AAP were as follows: enzalutamide (n=23 [85.2%] vs n=36 [90.0%]) and apalutamide (n=3 [11.1%] vs n=3 [7.5%]).
eThe most common in AKEEGA plus prednisone vs placebo/AAP was: olaparib (n=10 [100%] vs n=42 [89.4%]), respectively.
fCapivasertib, ODM 208, AMG 509, vobramitamab duocarmazine, ZEN 3694, cabozantinib, datopotamab deruxtecan, enfortumab vedotin, investigational antineoplastic drugs, NUV 868, zanzalintinib.

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 01 July 2025. 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 2025 July 01]. 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 KN, Castro E, Attard G, et al. Niraparib and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: final overall survival analysis for the phase 3 MAGNITUDE trial. Eur Urol Oncol. 2025;8(4):986-998.  
6 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 recombination 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.  
7 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 2025 July 01]. Available from: https://clinicaltrials.gov/show/NCT04497844 NLM Identifier: NCT04497844.  
8 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.  
9 Attard G, Agarwal N, Graff JN, et al. Phase 3 AMPLITUDE trial: niraparib and abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer patients with alterations in homologous recombination repair genes. Oral Presentation presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2025; Chicago, IL.  
10 Attard G, Agarwal N, Graff JN, et al. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025;31(12):4109-4118.  
11 Attard G, Aggarwal N, Graff JN, et al. Supplement to: Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025;31(12):4109-4118.