# US 2019/0167790 A1 · Abt-165 in combination with folinic acid, 5-fluorouracil, and irinotecan for the treatment of cancers

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- Number: US 2019/0167790 A1
- Document ID: US20190167790A1
- Status: Published application
- Kind: A1
- Application number: 16/207,758
- Filed: 2018-12-03
- Published: 2019-06-06
- Earliest claimed: 2017-12-05
- Assignees: AbbVie Biotherapeutics Inc.
- Applicants: AbbVie Biotherapeutics Inc.
- Inventors: Louie Naumovski
- Web page: https://patentgrep.com/patent/US20190167790A1

## CPC

- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48)
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61P 35/00: Antineoplastic agents
- C07K 16/22: against growth factors {; against growth regulators}
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- A61K 2039/505: {comprising antibodies}
- C07K 2317/32: specific for a neo-epitope on a complex, e.g. antibody-antigen or ligand-receptor
- C07K 2317/35: Valency
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- 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

This invention pertains to a method for the treatment of cancer in a subject comprising administering to the subject an effective amount of ABT-165 in combination with folinic acid, 5-fluorouracil and irinotecan (FOLFIRI).

## Claims

### Claim 1

A method for the treatment of colorectal cancer in a subject who is in need thereof, comprising administering to the subject an effective amount of a dual-variable domain immunoglobulin molecule with dual specificity for both delta-like ligand 4 (DLL4) and vascular endothelial growth factor (VEGF), ABT-165, dosed at about 2.5 mg/kg in combination with folinic acid and 5-fluorouracil.

### Claim 2 (depends on 1)

The method of claim 1, wherein ABT-165 is dosed once every 2 weeks in a subject.

### Claim 3 (depends on 1)

The method of claim 1, wherein ABT-165 is dosed in combination with folinic acid, 5-fluorouracil, and irinotecan to a subject.

### Claim 4 (depends on 1)

The method of claim 1, wherein ABT-165 is dosed at about 2.5 mg/kg every 2 weeks in combination with folinic acid, 5-fluorouracil, and irinotecan to a subject.

### Claim 5 (depends on 1)

The method of claim 1, wherein ABT-165 is dosed at about 2.5 mg/kg every 2 weeks in combination with folinic acid, 5-fluorouracil, and irinotecan to a subject as first line therapy.

### Claim 6 (depends on 1)

The method of claim 1, wherein ABT-165 is dosed at about 2.5 mg/kg every 2 weeks in combination with folinic acid, 5-fluorouracil, and irinotecan to a subject as second line or higher therapy.

### Claim 7

A method for the treatment of cancer that is sensitive to FOLFIRI therapy, comprising administering to the subject an effective amount of a dual-variable domain immunoglobulin molecule with dual specificity for both delta-like ligand 4 (DLL4) and vascular endothelial growth factor (VEGF), ABT-165, dosed at about 2.5 mg/kg in combination with folinic acid and 5-fluorouracil, wherein said cancer is selected from the group consisting of: gastroesophageal cancer, pancreatic cancer, breast cancer, glioblastoma multiforme, ovarian cancer, or non-small cell lung cancer in a subject who is in need thereof.

### Claim 8 (depends on 7)

The method of claim 7, wherein ABT-165 is dosed once every 2 weeks in a subject.

### Claim 9 (depends on 7)

The method of claim 7, wherein ABT-165 is dosed in combination with folinic acid, 5-fluorouracil, and irinotecan to a subject.

### Claim 10 (depends on 7)

The method of claim 7, wherein ABT-165 is dosed at about 2.5 mg/kg every 2 weeks in combination with folinic acid, 5-fluorouracil, and irinotecan to a subject.

### Claim 11 (depends on 7)

The method of claim 7, wherein ABT-165 is dosed at about 2.5 mg/kg every 2 weeks in combination with folinic acid, 5-fluorouracil, and irinotecan to a subject as first line therapy.

### Claim 12 (depends on 7)

The method of claim 7, wherein ABT-165 is dosed at about 2.5 mg/kg every 2 weeks in combination with folinic acid, 5-fluorouracil, and irinotecan to a subject as second line or higher therapy.
