# US 11,110,179 B2 · Combination of CD33 antibody drug conjugates with chemotherapeutic agents

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- Number: US 11,110,179 B2
- Document ID: US11110179B2
- Status: Granted
- Kind: B2
- Application number: 16/306,118
- Filed: 2017-06-02
- Published: 2019-05-09
- Granted: 2021-09-07
- Earliest claimed: 2016-06-03
- Assignees: Seagen Inc.
- Applicants: Seagen Inc.
- Inventors: Dana Kennedy; Eric Feldman
- Web page: https://patentgrep.com/patent/US11110179B2

## CPC

- A61K 31/5517: condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
- A61K 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)}
- A61K 31/7068: having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K 47/68035: {the drug being a pyrrolobenzodiazepine}
- A61K 47/6867: {the tumour determinant being from a cell of a blood cancer}
- A61P 35/02: specific for leukemia
- C07K 16/2803: {against the immunoglobulin superfamily}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- 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 relates to treatment of cancer using a CD33 antibody drug conjugate in combination with chemotherapeutic agents.

## Claims

### Claim 1

A method of treating CD33 expressing acute myeloid leukemia (AML) in a subject in need of such treatment, the method comprising:
1) administering an anthracycline antibiotic, and a CD33 antibody drug conjugate (ADC) in an induction period of seven days, wherein the CD33-ADC comprises a humanized 2H12 antibody and a PBD cytotoxic agent, and wherein 10 μg/kg or 20 μg/kg of the CD33-ADC is administered on day one of the induction period and 10 μg/kg of the CD33-ADC is administered on day four of the induction period;
wherein the anthracycline antibiotic: 1) is cytarabine and is administered on induction days 1-7; or 2) is daunorubicin and is administered on induction days 1-3; and
2) after the induction period, administering the CD33-ADC and cytarabine in up to four consolidation cycles each comprising seven days, wherein the CD33-ADC is administered on day 1 of each consolidations cycle at 10 μg/kg or 20 μg/kg, and wherein cytarabine is administered on days 1, 3, and 5 of each consolidation cycles at 3 mg/m2/day.

### Claim 2 (depends on 1)

The method of claim 1, wherein the PBD cytotoxic agent has the formula

### Claim 3 (depends on 1)

The method of claim 1, wherein the anthracycline antibiotic is daunorubicin and is administered at 60 mg/m2/day on induction days 1-3.

### Claim 4 (depends on 1)

The method of claim 1, wherein the anthracycline antibiotic is cytarabine and is administered at 100 mg/m2/day on induction days 1-7.

### Claim 5 (depends on 1)

The method of claim 1, wherein the humanized 2H12 antibody comprises a light chain variable region of SEQ ID NO:1 and a heavy chain variable region of SEQ ID NO:2.

### Claim 6

A method of treating CD33 expressing acute myeloid leukemia (AML) in a subject in need of such treatment, the method comprising:
1) administering an anthracycline antibiotic, and a CD33 antibody drug conjugate (ADC) in an induction period of seven days, wherein the CD33-ADC comprises a humanized 2H12 antibody and a PBD cytotoxic agent, and wherein 30 μg/kg or 40 μg/kg of the CD33-ADC is administered on day one of the induction period;
wherein the anthracycline antibiotic: 1) is cytarabine and is administered on induction days 1-7; or 2) is daunorubicin and is administered on induction days 1-3; and
2) after the induction period, administering the CD33-ADC and cytarabine in up to four consolidation cycles each comprising seven days, wherein the CD33-ADC is administered on day 1 of each consolidations cycle at 10 μg/kg or 20 μg/kg, and wherein cytarabine is administered on days 1, 3, and 5 of each consolidation cycles at 3 mg/m2/day.

### Claim 7 (depends on 6)

The method of claim 6, wherein the PBD cytotoxic agent has the formula

### Claim 8 (depends on 6)

The method of claim 6, wherein the anthracycline antibiotic is daunorubicin and is administered at 60 mg/m2/day on induction days 1-3.

### Claim 9 (depends on 6)

The method of claim 6, wherein the anthracycline antibiotic is cytarabine and is administered at 100 mg/m2/day on induction days 1-7.

### Claim 10 (depends on 6)

The method of claim 6, wherein the humanized 2H12 antibody comprises a light chain variable region of SEQ ID NO:1 and a heavy chain variable region of SEQ ID NO:2.

### Claim 11 (depends on 1)

The method of claim 1, wherein the method further comprising, after the consolidation cycles, administering the CD33-ADC in up to eight maintenance cycles each comprising forty two days, wherein the CD33-ADC is administered at 5 μg/kg on day 1 of each maintenance cycle.

### Claim 12 (depends on 6)

The method of claim 6, wherein the method further comprising, after the consolidation cycles, administering the CD33-ADC in up to eight maintenance cycles each comprising forty two days, wherein the CD33-ADC is administered at 5 μg/kg on day 1 of each maintenance cycle.