# US 10,945,990 B2 · Combination of a PD-1 antagonist and eribulin for treating cancer

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- Number: US 10,945,990 B2
- Document ID: US10945990B2
- Status: Granted
- Kind: B2
- Application number: 15/554,540
- Filed: 2016-03-03
- Published: 2018-03-15
- Granted: 2021-03-16
- Earliest claimed: 2015-03-04
- Assignees: Eisai R&D Management Co., Ltd.; Merck Sharp & Dohme Corp.
- Applicants: Merck Sharp & Dohme Corp.; Eisai R&D Management Co., Ltd.
- Inventors: Junji Matsui; Gursel Aktan; Vassiliki Karantza; RuiRong Yuan; Yasuhiro Funahashi; Erhan Berrak
- Web page: https://patentgrep.com/patent/US10945990B2

## CPC

- A61K 31/357: having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
- A61K 9/0019: {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)}
- A61K 39/39566: {against immunoglobulins, e.g. anti-idiotypic antibodies}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/14: for lactation disorders, e.g. galactorrhoea
- A61P 35/00: Antineoplastic agents
- A61P 35/04: specific for metastasis
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/2818: {against CD28 or CD152}
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- 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
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

The present disclosure describes combination therapies comprising an antagonist of Programmed Death 1 receptor (PD-1) and eribulin or a pharmaceutically acceptable salt thereof, and the use of the combination therapies for the treatment of cancer.

## Claims

### Claim 1

A method for treating triple negative breast cancer in an individual comprising administering to the individual a combination therapy which comprises (i) an antagonist of a Programmed Death 1 protein (PD-1), wherein the PD-1 antagonist is pembrolizumab, and (ii) eribulin or a pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the individual is a human.

### Claim 3 (depends on 1)

The method of claim 1, wherein the triple negative breast cancer is metastatic.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pharmaceutically acceptable salt of eribulin is eribulin mesylate.

### Claim 5 (depends on 1)

The method of claim 1, wherein the eribulin or the pharmaceutically acceptable salt thereof is administered at a dose of 1.4 mg/m2, 1.1 mg/m2, or 0.7 mg/m2 on days 1 and 8 of a 21-day cycle, wherein the pembrolizumab is administered at a dose of 200 mg Q3W.

### Claim 6 (depends on 1)

The method of claim 1, wherein the cancer tests positive for PD-L1 expression by an immunohistochemical assay.