Methods of treating prostate cancer with GnRH antagonist

Patent metadata

Field	Value
Publication number	US-10973870-B2
Application number	US-202016851179-A
Country	US
Kind code	B2
Filing date	Apr 17, 2020
Priority date	Feb 11, 2008
Publication date	Apr 13, 2021
Grant date	Apr 13, 2021

Abstract

The invention provides methods and dosing regimens for safely and effectively treating androgen-dependent prostate cancer with a gonadotrophin releasing hormone (GnRH) antagonist without causing a testosterone spike and/or other side effect of GnRH agonist therapy such as a urinary tract infection, or an arthralgia-related or cardiovascular side effect.

First claim

The invention claimed is:

1. A method of treating locally advanced prostate cancer in a subject, comprising:
choosing a dosing regimen of degarelix over gonadotrophin releasing hormone (GnRH) agonist treatment to decrease the likelihood of developing a musculoskeletal disorder or a connective tissue disorder compared to GnRH agonist treatment when treating prostate cancer in the subject; and
administering the dosing regimen of degarelix of an initial dose of 160-320 mg of degarelix to the subject and a maintenance dose of 60-160 mg of degarelix to the subject, wherein following the initial dose, the maintenance dose is administered once every 20-36 days thereafter.

2. The method of claim 1 , wherein the subject is less than 65 years old.

3. The method of claim 1 , wherein the treatment provides a decreased likelihood of developing or experiencing an increase in arthralgia compared to the treatment with the GnRH agonist.

4. The method of claim 1 , wherein the treatment provides a decreased likelihood of developing or experiencing an increase in muscle stiffness compared to the treatment with the GnRH agonist.

5. The method of claim 1 , wherein the initial dose is 240 mg of degarelix and the maintenance dose is about 80 mg of degarelix, wherein the maintenance dose is administered once every approximately 28 days of treatment.

6. The method of claim 1 , wherein the initial dose of degarelix is administered as two subcutaneous injections.

7. The method of claim 1 , wherein the maintenance dose of degarelix is administered monthly.

8. The method of claim 1 , wherein the GnRH agonist is leuprolide.

9. The method of claim 1 , wherein the subject has a body mass index of less than 30 kg/m 2 .

10. The method of claim 1 , wherein the initial dose of degarelix is administered at a concentration ranging from 5 mg/mL to 40 mg/mL.

11. The method of claim 1 , wherein the initial dose of degarelix is administered at a concentration of 40 mg/mL.

12. The method of claim 1 , wherein the maintenance dose of degarelix is administered as a single injection.

13. The method of claim 1 , wherein the maintenance dose of degarelix is administered at a concentration ranging from 5 mg/mL to 40 mg/m L.

14. The method of claim 1 , wherein the maintenance dose of degarelix is administered at a concentration of 20 mg/m L.

15. A method of treating locally advanced prostate cancer in a subject comprising:
choosing a dosing regimen of degarelix over leuprolide treatment to decrease the likelihood of developing a musculoskeletal disorder or a connective tissue disorder compared to leuprolide treatment when treating prostate cancer in the subject; and
administering the dosing regimen of degarelix of an initial dose of 160-320 mg of degarelix to the subject and a maintenance dose of 60-160 mg of degarelix to the subject, wherein following the initial dose, the maintenance dose is administered once every 20-36 days thereafter.

Assignees

• Ferring Bv

Inventors

• Olesen Tine Kold
• Persson Bo-Eric
• Cantor Per
• Van Der Meulen Egbert A
• Jensen Jens-Kristian Slott

Classifications

• A61P35/04

  specific for metastasis · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61K38/08

  Peptides having 5 to 11 amino acids {(A61K38/043 - A61K38/046 take precedence)} · CPC title

• A61K38/09 Primary

  Luteinising hormone-releasing hormone [LHRH] {, i.e. Gonadotropin-releasing hormone [GnRH]}; Related peptides · CPC title