# US 11,992,529 B2 · Adjuvant treatment of HER2-positive breast cancer

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- Number: US 11,992,529 B2
- Document ID: US11992529B2
- Status: Granted
- Kind: B2
- Application number: 17/305,556
- Filed: 2021-07-09
- Published: 2021-10-28
- Granted: 2024-05-28
- Earliest claimed: 2017-03-02
- Assignees: Genentech, Inc.; Hoffmann-La Roche Inc.
- Applicants: Genentech, Inc.; Hoffmann-La Roche Inc.
- Inventors: Mark C. Benyunes; Graham Alexander Ross
- Web page: https://patentgrep.com/patent/US11992529B2

## 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 adjuvant therapy for increasing invasive disease free survival (IDFS) at 3 years in patients with HER2-positive, node positive or hormone receptor negative, early breast cancer, comprising administering to said patients, following surgery:
(a) anthracycline-based chemotherapy comprising:
(i) 3 or 4 cycles of 5-fluorouracil+epirubicin+cyclophosphamide (FEC) or 5-fluorouracil+doxorubicin+cyclophosphamide (FAC); or
(ii) 4 cycles of doxorubicin+cyclophosphamide (AC) or epirubicin+cyclophosphamide (EC);
(b) following said anthracycline-based chemotherapy, pertuzumab, trastuzumab, and taxane-based chemotherapy, wherein:
(i) pertuzumab and trastuzumab are each administered intravenously starting on Day 1 of a first taxane-containing cycle and administered for 52 weeks;
(ii) an initial dose of pertuzumab is 840 mg followed every 3 weeks by 420 mg pertuzumab;
(iii) an initial dose of trastuzumab is 8 mg/kg followed every 3 weeks by 6 mg/kg trastuzumab; and
(iv) said taxane-based chemotherapy comprises 3 or 4 cycles of 75 mg/m2 and/or 100 mg/m2 docetaxel every 3 weeks or 12 cycles of 80 mg/m2 paclitaxel every week; and
wherein said IDFS at 3 years from initial administration in said patients is increased compared to patients to whom anthracycline-based chemotherapy, taxane-based chemotherapy, and trastuzumab without pertuzumab are administered.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

The method of claim 2, wherein said node positive patients have 4 or more involved lymph nodes.

### Claim 4 (depends on 3)

The method of claim 3, wherein said node positive patients have 4 to 9 involved lymph nodes.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

The method of claim 1, wherein said patients have a tumor >2 cm.

### Claim 8 (depends on 1)

The method of claim 1, wherein cardiac toxicity in said patients is not increased compared to patients to whom anthracycline-based chemotherapy, taxane-based chemotherapy, and trastuzumab without pertuzumab are administered, wherein said cardiac toxicity comprises drop in left ventricular ejection fraction (LVEF) of at least 10 points from baseline and to below 50%.

### Claim 9 (depends on 8)

The method of claim 8, wherein said cardiac toxicity comprises asymptomatic or mildly symptomatic decline in L VEF defined by NYHA as Class II toxicity.

### Claim 10 (depends on 8)

The method of claim 8, wherein said cardiac toxicity comprises symptomatic heart failure defined by NYHA as Class III/IV toxicity.

### Claim 11 (depends on 8)

The method of claim 8, wherein said patients have a baseline left ventricular ejection fraction (LVEF) ≥55%.