# US 2019/0167639 A1 · Synergistic pharmaceutical combination for the treatment of squamous cell carcinoma of head and neck

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- Number: US 2019/0167639 A1
- Document ID: US20190167639A1
- Status: Published application
- Kind: A1
- Application number: 16/270,643
- Filed: 2019-02-08
- Published: 2019-06-06
- 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/US20190167639A1

## 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 at position 1

1-20. (canceled)

### Claim 21

A method of treating cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a CDK inhibitor of Formula I, or a pharmaceutically acceptable salt or solvate thereof, and a therapeutically effective amount of an antineoplastic agent selected from sorafenib, lapatinib, erlotinib, cisplatin, 5-fluorouracil, docetaxel, and cetuximab, wherein in Formula I Ar is 2-chloro-phenyl or 2-chloro-4-trifluoromethyl phenyl:

### Claim 22 (depends on 21)

The method of claim 21, wherein the pharmaceutically acceptable salt is (+)-trans-2-(2-chloro-phenyl)-5,7-dihydroxy-8-(2-hydroxymethyl-1-methyl-pyrrolidin-3-yl)-chromen-4-one hydrochloride.

### Claim 23 (depends on 21)

The method of claim 21, wherein the pharmaceutically acceptable salt is (+)-trans-2-(2-chloro-4-trifluoromethylphenyl)-5,7-dihydroxy-8-(2-hydroxymethyl-1-methyl-pyrrolidin-3-yl)-chromen-4-one hydrochloride.

### Claim 24 (depends on 21)

The method of claim 21, wherein the antineoplastic agent is sorafenib.

### Claim 25 (depends on 21)

The method of claim 21, wherein the antineoplastic agent is lapatinib.

### Claim 26 (depends on 21)

The method of claim 21, wherein the antineoplastic agent is erlotinib.

### Claim 27 (depends on 21)

The method of claim 21, wherein the antineoplastic agent is cisplatin.

### Claim 28 (depends on 21)

The method of claim 21, wherein the antineoplastic agent is 5-fluorouracil.

### Claim 29 (depends on 21)

The method of claim 21, wherein the antineoplastic agent is docetaxel.

### Claim 30 (depends on 21)

The method of claim 21, wherein the antineoplastic agent is cetuximab.

### Claim 31 (depends on 21)

The method of claim 21, wherein the cancer is squamous cell carcinoma.

### Claim 32 (depends on 21)

The method of claim 21, wherein the cancer is head and neck cancer.

### Claim 33 (depends on 21)

The method of claim 21, wherein the cancer is tongue cancer.

### Claim 34 (depends on 21)

The method of claim 21, wherein the cancer is pharyngeal cancer.

### Claim 35 (depends on 21)

The method of claim 21, further comprising administration of radiation.