IP Library › Granted Patent US 12,734,180
Granted Patent B2
US 12,734,180 · App. 17/998,198 · Granted Sep 15, 2026

Treatment of prostate cancer with a combination of abiraterone acetate, niraparib tosylate monohydrate and prednisone

Inventors: Thomas Ronald A. Quinten (Zeveneken, BE); Urbain Alfons C. Delaet (Balen, BE); Philip Erna H. Heyns (Vosselaar, BE); Tatiana Marcozzi (Borgerhout, BE); Johny Bertels (Mol, BE); Katrien Luyten (Oud-Turnhout, BE); Kaustubh Ramesh Tambwekar (Geel, BE); Angela Lopez-Gitlitz (Los Angeles, CA); Paul J. A. Hartman Kok (Eersel, NL)
Assignee: Janssen Pharmaceutica NV
A61K31/58A61K9/1617A61K9/1635A61K9/1694A61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/2054A61K9/28A61K31/454A61K31/573A61K38/25A61P13/08A61P15/00A61P35/00A61P35/04
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Quick Facts
Patent No.
US 12,734,180
App. No.
17/998,198
Granted
Sep 15, 2026
Kind
B2
Abstract

The present disclosure relates to a combination of abiraterone acetate and niraparib, free-dose and fixed-dose combinations of abiraterone acetate and niraparib, and methods of treatment of prostate cancer with said combinations.

Claims (18)

1 . A method for the treatment of prostate cancer in a male human patient, said method comprising administering to the patient an effective amount of a pharmaceutical formulation comprising abiraterone acetate and niraparib tosylate monohydrate, plus prednisone, wherein the patient has received or continues with gonadotropin releasing hormone agonists (GnRHa) therapy, or has undergone bilateral orchiectomy, prior to the treatment with the pharmaceutical formulation, plus prednisone.

2 . The method of claim 1 , wherein the prostate cancer is mCRPC.

3 . The method of claim 1 , wherein the mCRPC is first-line (L1) mCRPC.

4 . The method of claim 1 , wherein the patient is positive for homologous recombination deficiency (HRD), or the patient is not positive for HRD.

5 . The method of claim 4 , wherein the HRD status is detected by monoallelic or biallelic alterations in one or more DNA repair genes comprising BRCA1 (Breast Cancer gene 1), BRCA2 (Breast Cancer gene 2), ATM (ataxia-telangiectasia mutated), FANCA (Fanconi Anemia Complementation Group A gene), PALB2 (Partner and Localizer of BRCA2 gene), CHEK2 (Checkpoint Kinase 2 gene), BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1 gene), HDAC2 (Histone deacetylase 2), or CDK12 (Cyclin Dependent Kinase 12).

6 . The method of claim 1 , wherein the patient continues with the GnRHa therapy during the treatment with the pharmaceutical formulation, plus prednisone, if not surgically castrated.

7 . A method for the treatment of mCRPC, with or without DNA-repair gene defects (DRD) or HRD in a male human patient, said method comprising administering to the patient an effective amount of a pharmaceutical formulation comprising abiraterone acetate and niraparib tosylate monohydrate, plus prednisone, wherein the mCRPC is also with cyclin dependent kinase 12 (CDK12) pathogenic alterations.

8 . A method for the treatment of mCRPC, with or without DNA-repair gene defects (DRD) or HRD in a male human patient, said method comprising administering to the patient an effective amount of a pharmaceutical formulation comprising abiraterone acetate and niraparib tosylate monohydrate, plus prednisone, wherein the patient continues with gonadotropin releasing hormone agonists (GnRHa) therapy during the treatment with the pharmaceutical formulation plus prednisone, if not surgically castrated.

9 . A method for the treatment of mCRPC, with or without DNA-repair gene defects (DRD) or HRD in a male human patient, said method comprising administering to the patient an effective amount of a pharmaceutical formulation comprising abiraterone acetate and niraparib tosylate monohydrate, plus prednisone, wherein the patient continues with gonadotropin releasing hormone agonists (GnRHa) therapy during the treatment with the pharmaceutical formulation plus prednisone, if not surgically castrated, and wherein the patient has been exposed to anti-androgens selected from nilutamide, flutamide, bicalutamide, enzalutamide, apalutamide, darolutamide, and abiraterone acetate; prior to the treatment with the pharmaceutical formulation plus prednisone.

10 . A method for the treatment of mCRPC, with or without DNA-repair gene defects (DRD) or HRD in a male human patient, said method comprising administering to the patient an effective amount of a pharmaceutical formulation comprising abiraterone acetate and niraparib tosylate monohydrate, plus prednisone, wherein the patient has been exposed to anti-androgens selected from nilutamide, flutamide, bicalutamide, enzalutamide, apalutamide, darolutamide, and abiraterone acetate; prior to the treatment with the pharmaceutical formulation plus prednisone, wherein said anti-androgens are washed-out prior to the treatment with the pharmaceutical formulation plus prednisone.

11 . The method of claim 1 , wherein said pharmaceutical formulation is a free-dose combination (FrDC) of abiraterone acetate and niraparib; or a FrDC of abiraterone acetate and niraparib tosylate monohydrate.

12 . The method of claim 1 , wherein said pharmaceutical formulation is a fixed-dose combination (FDC) comprising abiraterone acetate and niraparib; or a FDC comprising abiraterone acetate and niraparib tosylate monohydrate.

13 . The method of claim 11 , wherein the FrDC or FDC comprise, each independently, about 50 mg niraparib eq. and about 500 mg abiraterone acetate; about 100 mg niraparib eq. and about 500 mg abiraterone acetate; about 50 mg niraparib eq. and about 375 mg abiraterone acetate; about 100 mg niraparib eq. and about 375 mg abiraterone acetate; about 50 mg niraparib eq. and about 250 mg abiraterone acetate; about 100 mg niraparib eq. and about 250 mg abiraterone acetate; about 33 mg niraparib eq. and about 333 mg abiraterone acetate; or about 67 mg niraparib eq. and about 333 mg abiraterone acetate.

14 . The method of claim 11 , wherein the FrDC or FDC are oral dosage forms.

15 . The method of claim 14 , wherein the oral dosage form is a tablet, a capsule, or a sachet.

16 . The method of claim 1 , wherein the patient is positive for homologous recombination deficiency (HRD) and the HRD status is detected by monoallelic or biallelic alterations in one or more DNA repair genes comprising BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast Cancer gene 2).

17 . The method of claim 8 , wherein the patient is positive for homologous recombination deficiency (HRD) and the HRD status is detected by monoallelic or biallelic alterations in one or more DNA repair genes comprising BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast Cancer gene 2).

18 . The method of claim 9 , wherein the patient is positive for homologous recombination deficiency (HRD) and the HRD status is detected by monoallelic or biallelic alterations in one or more DNA repair genes comprising BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast Cancer gene 2).

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 9, 2023
From: QUINTEN, THOMAS RONALD A; DELAET, URBAIN ALFONS C; HEYNS, PHILIP ERNA H; MARCOZZI, TATIANA; BERTELS, JOHNY; LUYTEN, KATRIEN; TMBWEKAR, KAUSTUBH RAMESH; HARTMAN KOK, PAUL J A
To: JANSSEN PHARMACEUTICA NV
Reel/Frame 062642/0946 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 9, 2023
From: LOPEZ-GITLITZ, ANGELA
To: JANSSEN RESEARCH & DEVELOPMENT, LLC
Reel/Frame 062643/0014 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 9, 2023
From: JANSSEN RESEARCH & DEVELOPMENT, LLC
To: JANSSEN PHARMACEUTICA NV
Reel/Frame 062643/0052 →
Priority Claims (1)
EP 20173749 · May 8, 2020 · regional
Continuity (3)
Provisional Application 63142919 · Jan 28, 2021
Provisional Application 63174282 · Apr 13, 2021
Related Publication 20230218640A1 · Jul 13, 2023
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Consider the impact of ZYTIGA (Registered) 500 mg film-coated tablets over the course of a month or a year for your patients with mCRPC, ZYTIGA (Registered) (abiraterone acetate) Dosing & Monitoring HCP, May 24, 2018, 7… [cited by applicant]
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Cougar Biotechnology Announces Initiation of Phase III Trial of CB7630 (Abiraterone Acetate), News Release, available at http://www.cougarbiotechnology.com (2008). [cited by applicant]
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Cougar Biotechnology Presents Positive CB7630 Clinical Data at AACR Annual Meeting Late-Breaking Clinical Trials Session, News Release, available at: http:www.cougarbiotechnology.com (2007). [cited by applicant]
Cougar Biotechnology Presents Positive CB7630 Phase II Data at Chemotherapy Foundation Symposium; News Release, available at: http://www.cougarbiotechnology.com (2007). [cited by applicant]
Cougar Biotechnology Presents Positive CB7630 Phase II Data at EORTC-NCI-AACR Symposium, News Release, available at: http://www.cougarbiotechnology.com (2008). [cited by applicant]
Cougar Biotechnology to Present Clinical Data on CB7630 (Abiraterone Acetate) at American Society of Clinical Oncology 2008 Annual Meeting. News Release, available at http://www.cougarbiotechnology.com (2008). [cited by applicant]