# US 12,005,057 B2 · Methods of treating ovarian cancer

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- Number: US 12,005,057 B2
- Document ID: US12005057B2
- Status: Granted
- Kind: B2
- Application number: 15/986,536
- Filed: 2018-05-22
- Published: 2018-11-01
- Granted: 2024-06-11
- Earliest claimed: 2016-06-29
- Assignees: Tesaro, Inc.
- Applicants: Tesaro, Inc.
- Inventors: Mary Lynne Hedley; Robert Martell
- Web page: https://patentgrep.com/patent/US12005057B2

## CPC

- A61K 31/454: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
- 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)
- A61P 35/00: Antineoplastic agents
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/156: Polymorphic or mutational markers
- 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
- 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

## Abstract

The present invention provides methods of administering a PARP inhibitor to a cancer patient.

## Claims

### Claim 1

A method of treating a patient diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, comprising
administering daily to said patient an oral dose of niraparib equivalent to 200 mg or 300 mg of niraparib free base,
wherein the patient has undergone at least one cycle of platinum-based chemotherapy; and
wherein the patient carries no germline or somatic mutation in BRCA1 or BRCA2 genes and the cancer has no homologous recombination deficiency.

### Claim 2 (depends on 1)

The method of claim 1, wherein the ovarian cancer, fallopian tube cancer, or primary peritoneal cancer is platinum sensitive.

### Claim 3 (depends on 1)

The method of claim 1, wherein the patient has undergone at least two cycles of platinum-based chemotherapy.

### Claim 4 (depends on 3)

The method of claim 3, wherein the patient has a complete response to the platinum-based chemotherapy.

### Claim 5 (depends on 3)

The method of claim 3, wherein the patient has a partial response to the platinum-based chemotherapy.

### Claim 6 (depends on 3)

The method of claim 3, wherein the administration of niraparib is commenced within 8 weeks of the end of the last cycle of platinum-based chemotherapy.

### Claim 7 (depends on 1)

The method of claim 1, comprising administering the niraparib in continuous 28-day cycles.

### Claim 8 (depends on 1)

The method of claim 1, wherein the niraparib is administered daily for a period of 6.9 months, and wherein administration is continued until disease progression occurs.

### Claim 9 (depends on 1)

The method of claim 1, comprising administering daily to said patient an oral dose of niraparib tosylate monohydrate.

### Claim 10 (depends on 9)

The method of claim 9, comprising administering daily to said patient an oral dose of niraparib tosylate monohydrate equivalent to 200 mg of niraparib free base.

### Claim 11 (depends on 9)

The method of claim 9, comprising administering daily to said patient an oral dose of niraparib tosylate monohydrate equivalent to 300 mg of niraparib free base.

### Claim 12

A method of treating a patient diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, the method comprising administering daily to said patient an oral dose of niraparib, wherein the patient is HRD negative and wherein the patient has undergone at least one cycle of platinum-based chemotherapy.

### Claim 13 (depends on 12)

The method of claim 12 wherein the patient is BRCA1/2wt.

### Claim 14 (depends on 12)

The method of claim 12 wherein the patient is diagnosed as BRCAwt prior to administration of the oral dose of niraparib.

### Claim 15 (depends on 12)

The method of claim 12 wherein the niraparib is administered to the patient for at least one 28 day cycle.

### Claim 16 (depends on 15)

The method of claim 15 wherein the daily dose of niraparib is progressively reduced from an oral dose of niraparib equivalent to 300 mg to a dose of 200 mg of niraparib over the at least one 28 day cycle.

### Claim 17 (depends on 12)

The method of claim 12 wherein the niraparib is administered to the patient prior to determining that the patient is HRD negative.

### Claim 18

A method of treating a patient diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, consisting of
administering daily to said patient an oral dose of niraparib equivalent to 200 mg or 300 mg of niraparib free base,
wherein the patient has undergone at least one cycle of platinum-based chemotherapy; and
wherein the patient carries no germline or somatic mutation in BRCA1 or BRCA2 genes and the cancer has no homologous recombination deficiency.

### Claim 19

A method of treating a patient diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, the method consisting of administering daily to said patient an oral dose of niraparib, wherein the patient is HRD negative and wherein the patient has undergone at least one cycle of platinum-based chemotherapy.