# US 10,245,251 B2 · Synergistic pharmaceutical combination for the treatment of squamous cell carcinoma of head and neck

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- Number: US 10,245,251 B2
- Document ID: US10245251B2
- Status: Granted
- Kind: B2
- Application number: 15/206,185
- Filed: 2016-07-08
- Published: 2017-06-08
- Granted: 2019-04-02
- Earliest claimed: 2011-05-31
- Assignees: Piramal Enterprises Limited
- Applicants: Piramal Enterprises Limited
- Inventors: Veena Agarwal; Arun Balakrishnan; Giridharan Periyasamy
- Web page: https://patentgrep.com/patent/US10245251B2

## CPC

- A61K 31/4025: not condensed and containing further heterocyclic rings, e.g. cromakalim
- A61K 31/282: Platinum compounds
- A61K 31/337: having four-membered rings, e.g. taxol
- A61K 31/44: Non condensed pyridines; Hydrogenated derivatives thereof
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61K 31/517: ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
- A61K 33/24: Heavy metals; Compounds thereof
- A61K 33/243: Platinum; Compounds thereof
- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61P 35/00: Antineoplastic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to a pharmaceutical combination for use in the treatment of squamous cell carcinoma, comprising a CDK inhibitor selected from the compounds of formula (I); or a pharmaceutically acceptable salt thereof and one or more antineoplastic agents selected from sorafenib, lapatinib, erlotinib, cisplatin, 5-fluorouracil, docetaxel or cetuximab or a pharmaceutically acceptable salt thereof. The said pharmaceutical combination exhibits synergy when used in the treatment of squamous cell carcinoma of head and neck (SCCHN). The invention also relates to a pharmaceutical composition comprising the said combination and a method for the treatment of squamous cell carcinoma of head and neck (SCCHN), using a therapeutically effective amount of said combination.

## Claims

### Claim 1

A method for the treatment of squamous cell carcinoma of head and neck in a subject comprising administering to said subject a therapeutically effective amount of:
a CDK inhibitor of formula I:
wherein Ar is 2-chloro-4-trifluoromethylphenyl; or a pharmaceutically acceptable salt or solvate thereof; and
a therapeutically effective amount of one or more antineoplastic agents selected from sorafenib, and lapatinib.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the compound of formula I is (+)-trans-2-(2-chloro-4-trifluoromethylphenyl)-5,7-dihydroxy-8-(2-hydroxymethyl-1-methyl-pyrrolidin-3-yl)-chromen-4-one hydrochloride.

### Claim 3 (depends on 1)

The method according to claim 1, wherein said one or more antineoplastic agents is sorafenib.

### Claim 4 (depends on 1)

The method according to claim 1, wherein said one or more antineoplastic agents is lapatinib.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said method further comprises administration of radiation.