# US 10,870,889 B2 · Immunoglobulin expression levels as biomarker for proteasome inhibitor response

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- Number: US 10,870,889 B2
- Document ID: US10870889B2
- Status: Granted
- Kind: B2
- Application number: 14/910,668
- Filed: 2014-08-08
- Published: 2016-06-23
- Granted: 2020-12-22
- Earliest claimed: 2013-08-08
- Assignees: Onyx Therapeutics, Inc.
- Applicants: Onyx Therapeutics, Inc.
- Inventors: Brian Tuch; Jeremiah Degenhardt; Andrea Loehr; Kevin Kwei; Christopher J. Kirk
- Web page: https://patentgrep.com/patent/US10870889B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A61K 31/145: having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2) (isothiourea A61K31/155)
- A61K 31/69: Boron compounds
- A61K 38/05: Dipeptides
- A61K 38/07: Tetrapeptides
- A61P 35/02: specific for leukemia
- G01N 33/5759: {involving compounds localised on the membrane of tumour or cancer cells}
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/158: Expression markers
- G01N 2333/70535: Fc-receptors, e.g. CD16, CD32, CD64 (CD2314/705F)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Methods of treating a tumor in a subject and methods of determining a treatment regimen for a subject with a tumor are provided herein. In exemplary aspects, the methods comprise measuring the level of expression of immunoglobulin, FCGR2B, a gene listed in Table 4, or a combination thereof. In exemplary aspects, the subject is a subject from which a sample was obtained, wherein the level of immunoglobulin, FCGR2B, a gene listed in Table 4, or a combination thereof, has been measured from the sample. Related kits, computer readable-storage media, systems, and methods implemented by a processor in a computer are further provided.

## Claims

### Claim 1

A method for treating a tumor in a subject, said method comprising (i) determining the subject as responsive to treatment with a proteasome inhibitor by (a) obtaining a sample from the subject, wherein the sample comprises a cell from the tumor, (b) measuring the level of expression of Fc gamma receptor 2B (FCGR2B) in the sample and (c) determining the subject as responsive to treatment with a proteasome inhibitor when the level of expression of FCGR2B of the sample is greater than or equal to an FPKQ cutoff of 75 and (ii) administering to the subject an effective amount of a proteasome inhibitor.

### Claim 2 (depends on 1)

The method of claim 1, wherein the proteasome inhibitor is carfilzomib, bortezomib, or oprozomib.

### Claim 3 (depends on 1)

The method of claim 1, wherein the tumor is a hematological tumor.

### Claim 4 (depends on 2)

The method of claim 2, wherein the proteasome inhibitor is bortezomib.

### Claim 5 (depends on 3)

The method of claim 3, wherein the hematological tumor is a multiple myeloma.

### Claim 6 (depends on 1)

The method of claim 1, comprising measuring the level of expression of FCGR2B in CD138-positive tumor cells obtained from the subject.

### Claim 7 (depends on 1)

The method of claim 1, comprising extracting RNA from CD138-positive tumor cells.

### Claim 8 (depends on 1)

The method of claim 1, wherein the sample comprises CD138-positive tumor cells isolated from bone marrow cells.

### Claim 9 (depends on 1)

The method of claim 1, wherein
the subject (i) has previously been treated for multiple myeloma or (ii) has previously been diagnosed with multiple myeloma or (iii) is a human patient having or suspected of having multiple myeloma, refractory multiple myeloma, or relapsed multiple myeloma.

### Claim 10 (depends on 1)

The method of claim 1, wherein the method comprises use of a kit comprising one or more binding agents to FCGR2B gene or gene product.

### Claim 11 (depends on 2)

The method of claim 2, wherein the proteasome inhibitor is carfilzomib.

### Claim 12 (depends on 5)

The method of claim 5, wherein the multiple myeloma is relapsed multiple myeloma or refractory multiple myeloma.

### Claim 13 (depends on 1)

The method of claim 1, wherein the proteasome inhibitor is disulfiram.