# US 11,299,543 B2 · Use of an anti-PD-1 antibody in combination with an anti-CD30 antibody in cancer treatment

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- Number: US 11,299,543 B2
- Document ID: US11299543B2
- Status: Granted
- Kind: B2
- Application number: 16/306,282
- Filed: 2017-06-01
- Published: 2019-07-18
- Granted: 2022-04-12
- Earliest claimed: 2016-06-02
- Assignees: Bristol-Myers Squibb Company; Seattle Genetics. Tnc.
- Applicants: Bristol-Myers Squibb Company; Seattle Genetics, Inc.
- Inventors: Benedetto Farsaci; Neil Josephson; Anthony Cao; Ryan Heiser
- Web page: https://patentgrep.com/patent/US11299543B2

## CPC

- C07K 16/2818: {against CD28 or CD152}
- A61K 47/68031: {the drug being an auristatin}
- A61K 47/6849: {the antibody targeting a receptor, a cell surface antigen or a cell surface determinant}
- A61K 47/6877: {the antibody being an immunoglobulin containing regions, domains or residues from different species}
- A61K 47/6889: {Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment}
- A61P 35/00: Antineoplastic agents
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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)
- 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

This disclosure provides methods for treating a tumor in a subject comprising administering to the subject an anti-PD-1 antibody and an anti-CD30 antibody. In some embodiments, the tumor is derived from a lymphoma (e.g., a Hodgkin lymphoma or a non-Hodgkin lymphoma). In certain embodiments, the anti-CD30 antibody is an antibody-drug conjugate, e.g., brentuximab vedotin.

## Claims

### Claim 1

A method of treating a human subject afflicted with a Hodgkin lymphoma, comprising:
(a) administering to the human subject about 3 mg/kg of an antibody or an antigen-binding portion thereof that binds specifically to a Programmed Death-1 receptor (PD-1) and inhibits PD-1 activity (anti-PD-1 antibody) once every three weeks; and
(b) administering to the human subject about 1.8 mg/kg of brentuximab vedotin once every three weeks;
wherein (i) brentuximab vedotin is administered to the human subject on day 1 of a first 21-day cycle; and
(ii) the anti-PD-1 antibody is administered to the human subject on day 8 of the first 21-day cycle;
wherein a combination of brentuximab vedotin and the anti-PD-1 antibody is administered on day 1 of each of a second 21-day cycle, a third 21-day cycle; and a fourth 21-day cycle, wherein the second 21-day cycle, the third 21-day cycle, and the fourth 21-day cycle follow in succession after the first 21-day cycle; and
wherein the Hodgkin lymphoma comprises one or more cells that express CD30.

### Claim 2 (depends on 1)

The method of claim 1, wherein the Hodgkin lymphoma is classical Hodgkin lymphoma (cHL).

### Claim 3 (depends on 1)

The method of claim 1, wherein at least about 0.1% of the Hodgkin lymphoma cells express CD30.

### Claim 4 (depends on 1)

The method of claim 1, wherein at least about 5% of the Hodgkin lymphoma cells express CD30.

### Claim 5 (depends on 1)

The method of claim 1, wherein the anti-PD-1 antibody comprises nivolumab.

### Claim 6 (depends on 1)

The method of claim 1, wherein the Hodgkin lymphoma comprises one or more cells that express PD-L1, PD-L2, or both PD-L1 and PD-L2.

### Claim 7 (depends on 1)

The method of claim 1, wherein the human subject exhibits progression-free survival of at least about one month after the initial administration of the anti-PD-1 antibody and/or brentuximab vedotin.

### Claim 8 (depends on 1)

The method of claim 1, wherein the Hodgkin lymphoma is relapsed Hodgkin lymphoma or refractory Hodgkin lymphoma.

### Claim 9 (depends on 8)

The method of claim 8, wherein the relapsed Hodgkin lymphoma is relapsed Hodgkin lymphoma after autologous stem cell transplant (ASCT) or relapsed Hodgkin lymphoma in a human subject ineligible for ASCT.

### Claim 10 (depends on 1)

The method of claim 1, wherein the anti-PD-1 antibody comprises pembrolizumab.