Pharmaceutical combination for the treatment of melanoma

Patent metadata

Field	Value
Publication number	US-12383530-B2
Application number	US-202318497653-A
Country	US
Kind code	B2
Filing date	Oct 30, 2023
Priority date	Jul 12, 2013
Publication date	Aug 12, 2025
Grant date	Aug 12, 2025

Abstract

The present invention relates to a pharmaceutical combination comprising a cyclin dependent kinase (CDK) inhibitor represented by a compound of formula I (as described herein) or a pharmaceutically acceptable salt thereof; and at least one anticancer agent selected from a BRAF inhibitor or a MEK inhibitor, for use in the treatment of melanoma. The present invention also relates to a method for the treatment of melanoma comprising administering to a subject in need thereof, a therapeutically effective amount of a CDK inhibitor and a therapeutically effective amount of at least one anticancer agent selected from a BRAF inhibitor or a MEK inhibitor.

First claim

We claim:

1. A pharmaceutical combination for the treatment of melanoma, the combination comprising a therapeutically effective amount of a CDK (cyclin dependent kinase) inhibitor of formula I or a pharmaceutically acceptable salt thereof;

wherein Ar is 2 chloro-4-trifluoromethylphenyl; and a therapeutically effective amount of at least one anticancer agent selected from vemurafenib, dabrafenib, and trametinib.

2. The pharmaceutical combination according to claim 1 , wherein the CDK inhibitor is (+)-trans-2-(2-chloro-4-trifluoromethylphenyl)-5,7-dihydroxy-8-(2-hydroxymethyl-1-methyl-pyrrolidin-3-yl)-chromen-4-one hydrochloride.

3. The pharmaceutical combination according to claim 1 , wherein the anticancer agent is vemurafenib.

4. The pharmaceutical combination according to claim 1 , wherein the anticancer agent is dabrafenib.

5. The pharmaceutical combination according to claim 1 , wherein the anticancer agent is trametinib.

6. The pharmaceutical combination according to claim 1 , wherein the CDK inhibitor and the at least one anticancer agent are administered simultaneously to a subject in need thereof.

7. The pharmaceutical combination according to claim 1 , wherein the CDK inhibitor and the at least one anticancer agent are administered sequentially to a subject in need thereof.

8. The pharmaceutical combination according to claim 1 , wherein the melanoma is non-refractory melanoma.

9. The pharmaceutical combination according to claim 8 , wherein the melanoma is non-refractory BRAF mutant melanoma.

10. The pharmaceutical combination according to claim 9 , wherein the melanoma is non-refractory BRAFV600 mutant melanoma.

11. The pharmaceutical combination according to claim 10 , wherein the melanoma is non-refractory BRAFV600E or BRAFV600K mutant melanoma.

12. The pharmaceutical combination according to claim 1 , wherein the melanoma is recurrent or refractory melanoma.

13. The pharmaceutical combination according to claim 12 , wherein the melanoma is recurrent or refractory BRAF mutant melanoma.

14. The pharmaceutical combination according to claim 13 , wherein the melanoma is recurrent or refractory BRAFV600 mutant melanoma.

15. The pharmaceutical combination according to claim 14 , wherein the melanoma is recurrent or refractory BRAFV600E melanoma or BRAFV600K mutant melanoma.

16. The pharmaceutical combination according to claim 1 , wherein the melanoma is metastatic melanoma.

17. The pharmaceutical combination according to claim 16 , wherein the melanoma is metastatic BRAF mutant melanoma.

18. The pharmaceutical combination according to claim 17 , wherein the melanoma is metastatic BRAFV600 mutant melanoma.

19. The pharmaceutical combination according to claim 18 , wherein the melanoma is metastatic BRAFV600E melanoma or BRAFV600K mutant melanoma.

Assignees

• Piramal Entpr Ltd

Inventors

• Agarwal Veena
• Periyasamy Giridharan
• Rathos Maggie
• Srivastava Ankita
• Srinivasa Sreesha

Classifications

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K31/519

  ortho- or peri-condensed with heterocyclic rings · CPC title

• A61K31/506

  not condensed and containing further heterocyclic rings · CPC title

• A61K31/437

  the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title