# US 11,077,189 B2 · Adjuvant treatment of HER2-positive breast cancer

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- Number: US 11,077,189 B2
- Document ID: US11077189B2
- Status: Granted
- Kind: B2
- Application number: 15/907,718
- Filed: 2018-02-28
- Published: 2018-09-06
- Granted: 2021-08-03
- Earliest claimed: 2017-03-02
- Assignees: Genentech, Inc.; Hoffmann-La Roche Inc.
- Applicants: Genentech, Inc.; F. Hoffmann-La Roche AG
- Inventors: Mark C. Benyunes; Graham Alexander Ross
- Web page: https://patentgrep.com/patent/US11077189B2

## CPC

- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 31/513: having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
- A61K 31/555: containing heavy metals, e.g. hemin, hematin, melarsoprol
- A61K 31/675: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
- A61K 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 35/00: Antineoplastic agents
- C07K 16/32: against translation products of oncogenes
- A61K 31/337: having four-membered rings, e.g. taxol
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- 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
- 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

Methods are provided for the adjuvant treatment of operable HER2-positive primary breast cancer in human patients by administration of pertuzumab in addition to chemotherapy and trastuzumab. The methods reduce the risk of recurrence of invasive breast cancer or death for a patient diagnosed with HER2-positive early breast cancer (eBC) compared to administration of trastuzumab and chemotherapy, without pertuzumab.

## Claims

### Claim 1

A method of increasing invasive disease free survival (IDFS) at 3 years in HER2-positive early breast cancer patients without increase in cardiac toxicity, wherein the patients have a high risk of cancer recurrence, have a baseline left ventricular ejection fraction (LVEF)≥55%, and have not received prior anti-HER2 therapy, comprising administering to said patients, following surgery:
(a) anthracycline-based chemotherapy selected from:
(i) 3-4 cycles of 500-600 mg/m2 5-FU+90-120 mg/m2 epirubicin+500-600 mg/m2 cyclophosphamide, or of 500-600 mg/m2 5-FU+50 mg/m2 doxorubicin+500-600 mg/m2 cyclophosphamide; or
(ii) 4 cycles of 60 mg/m2 doxorubicin+500-600 mg/m2 cyclophosphamide, or of 90-120 mg/m2 epirubicin+500-600 mg/m2 cyclophosphamide;
(b) following said anthracycline-based chemotherapy, taxane comprising 4 cycles of 75 mg/m2 or 100 mg/m2 docetaxel every 3 weeks or 12 cycles of 80 mg/m2 paclitaxel every week, wherein the taxane is administered in combination with pertuzumab, and trastuzumab, and pertuzumab and trastuzumab are each administered intravenously starting on Day 1 of the first taxane-containing cycle and administered for a total of 52 weeks, and wherein an initial dose of pertuzumab is 840 mg followed every 3 weeks by 420 mg pertuzumab, and an initial dose of trastuzumab is 8 mg/kg followed every 3 weeks by 6 mg/kg trastuzumab,
wherein said IDFS at 3 years from initial administration in said patients is increased compared to patients to whom anthracycline-based chemotherapy, taxane, and trastuzumab without pertuzumab are administered, wherein the cardiac toxicity is a LVEF decline ≥10 points from baseline and a drop to less than 50%, and wherein said high risk patients are node positive or hormone receptor negative.

### Claim 2 (depends on 1)

The method of claim 1, wherein said high risk patients are node positive.

### Claim 3 (depends on 1)

The method of claim 1, wherein said high risk patients are hormone receptor negative.

### Claim 4 (depends on 1)

The method of claim 1, wherein said high risk patients are node positive and hormone receptor negative.