HRP20240069T1 - Adjuvantno liječenje her2-pozitivnog raka dojke - Google Patents
Adjuvantno liječenje her2-pozitivnog raka dojke Download PDFInfo
- Publication number
- HRP20240069T1 HRP20240069T1 HRP20240069TT HRP20240069T HRP20240069T1 HR P20240069 T1 HRP20240069 T1 HR P20240069T1 HR P20240069T T HRP20240069T T HR P20240069TT HR P20240069 T HRP20240069 T HR P20240069T HR P20240069 T1 HRP20240069 T1 HR P20240069T1
- Authority
- HR
- Croatia
- Prior art keywords
- pertuzumab
- trastuzumab
- chemotherapy
- combination
- administered
- Prior art date
Links
- 208000017891 HER2 positive breast carcinoma Diseases 0.000 title 1
- 238000009098 adjuvant therapy Methods 0.000 title 1
- 229960002087 pertuzumab Drugs 0.000 claims 29
- 229960000575 trastuzumab Drugs 0.000 claims 28
- 238000002512 chemotherapy Methods 0.000 claims 23
- 238000000034 method Methods 0.000 claims 17
- 238000001990 intravenous administration Methods 0.000 claims 5
- 206010006187 Breast cancer Diseases 0.000 claims 4
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 claims 4
- AOJJSUZBOXZQNB-TZSSRYMLSA-N Doxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-TZSSRYMLSA-N 0.000 claims 4
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims 4
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims 4
- 229960004397 cyclophosphamide Drugs 0.000 claims 4
- 208000026310 Breast neoplasm Diseases 0.000 claims 3
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 claims 3
- 229960003668 docetaxel Drugs 0.000 claims 3
- 208000030776 invasive breast carcinoma Diseases 0.000 claims 3
- AOJJSUZBOXZQNB-VTZDEGQISA-N 4'-epidoxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-VTZDEGQISA-N 0.000 claims 2
- HTIJFSOGRVMCQR-UHFFFAOYSA-N Epirubicin Natural products COc1cccc2C(=O)c3c(O)c4CC(O)(CC(OC5CC(N)C(=O)C(C)O5)c4c(O)c3C(=O)c12)C(=O)CO HTIJFSOGRVMCQR-UHFFFAOYSA-N 0.000 claims 2
- GHASVSINZRGABV-UHFFFAOYSA-N Fluorouracil Chemical compound FC1=CNC(=O)NC1=O GHASVSINZRGABV-UHFFFAOYSA-N 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 2
- 229930012538 Paclitaxel Natural products 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 229960004679 doxorubicin Drugs 0.000 claims 2
- 229960001904 epirubicin Drugs 0.000 claims 2
- 229960002949 fluorouracil Drugs 0.000 claims 2
- 108091008039 hormone receptors Proteins 0.000 claims 2
- 229960001592 paclitaxel Drugs 0.000 claims 2
- 238000010254 subcutaneous injection Methods 0.000 claims 2
- 239000007929 subcutaneous injection Substances 0.000 claims 2
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims 2
- 230000003321 amplification Effects 0.000 claims 1
- 190000008236 carboplatin Chemical compound 0.000 claims 1
- 229960004562 carboplatin Drugs 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 238000007901 in situ hybridization Methods 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 210000001165 lymph node Anatomy 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 238000003199 nucleic acid amplification method Methods 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 238000001356 surgical procedure Methods 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
- A61K2039/507—Comprising a combination of two or more separate antibodies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Claims (16)
1. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom, naznačen time, da je za uporabu u postupku za smanjivanje rizika od povratka invazivnog raka dojke ili od smrti pacijenata kojima je dijagnosticiran HER2-pozitivni rani rak dojke (eBC) u usporedbi s primjenom trastuzumaba i kemoterapije, bez pertuzumaba, pri čemu postupak obuhvaća davanje navedenim pacijentima poslije operativnog zahvata raka dojke, pertuzumaba u kombinaciji s trastuzumabom i kemoterapijom, dok pacijenti imaju rani rak dojke pozitivan na limfne čvorove, s time, da se kemoterapija bira od sljedećih
a) 5-fluorouracil + epirubicin + ciklofosfamid ili 5-fluorouracil + doksorubicin + ciklofosfamid, pri čemu kemoterapija nadalje sadrži primjenu docetaksela ili paklitaksela; ili
b) doksorubicin + ciklofosfamid ili epirubicin + ciklofosfdamid, pri čemu kemoterapija nadalje sadrži primjenu docetaksela ili paklitaksela; ili
c) docetaksel + karboplatin.
2. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema patentnom zahtjevu 1, naznačen time, da pacijenti ostaju na životu bez povratka invazivnog raka dojke najmanje jednu godinu, najmanje dvije godine, ili najmanje tri godine nakon spomenute primjene.
3. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema patentnom zahtjevu 1 ili 2, naznačen time, da je rak dojke kod pacijenata negativan na hormonski receptor (HR).
4. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da je rizik od povratka invazivnog raka dojke ili od smrti smanjen najmanje za oko 5%, ili najmanje za oko 10%, ili najmanje za oko 15%, ili najmanje za oko 20%, ili najmanje za oko 25%, u usporedbi s primjenom trastuzumaba i kemoterapije, bez pertuzumaba.
5. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema bilo kojem od patentnih zahtjeva 1 do 4, pri čemu HER2 pozitivan rak je naznačen razinom ekspresije HER2 od IHC 2+ ili 3+.
6. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da je rak HER2-amplificiran, opcionalno gdje se HER2 amplifikacija utvrđuje putem fluorescentne in situ hibridizacije (FISH).
7. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da se pertuzumab i trastuzumab primjenjuju intravenozno.
8. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da se pertuzumab i trastuzumab primjenjuju svaka tri tjedna.
9. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema patentnom zahtjevu 8, naznačen time, da se pertuzumab daje kao 840 mg IV udarna doza, nakon čega slijedi 420 mg, što se daje putem IV svaka tri tjedna.
10. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema patentnom zahtjevu 8 ili 9, naznačen time, da se trastuzumab daje kao 8 mg/kg intravenozna (IV) udarna doza, nakon čega slijedi 6 mg/kg, što se daje putem IV infuzije svaka tri tjedna.
11. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da se barem jedan od pertuzumaba i trastuzumaba primjenjuje supkutano.
12. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema patentnom zahtjevu 11, naznačen time, da se pertuzumab daje supkutano s udarnom dozom od 1200 mg, nakon čega slijedi 600 mg svaka tri tjedna.
13. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema patentnom zahtjevu 11 ili 12, naznačen time, da se pertuzumab i trastuzumab daju zajedno supkutano kao dvije odvojene supkutane injekcije.
14. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema patentnom zahtjevu 11 ili 12, naznačen time, da se pertuzumab i trastuzumab daju kao jedinstvena supkutana injekcija, opcionalno pritom se pertuzumab i trastuzumab daju kao jedinstvena zajednička formulacija za supkutanu primjenu.
15. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema bilo kojem od patentnih zahtjeva 1 do 14, naznačen time, da se pertuzumab i trastuzumab primjenjuju u vremenu od najmanje 52 tjedna.
16. Pertuzumab u kombinaciji s trastuzumabom i kemoterapijom za uporabu u postupku prema bilo kojem od patentnih zahtjeva 1 do 15, naznačen time, da primjena pertuzumaba i trastuzumaba slijedi nakon kemoterapije.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762466239P | 2017-03-02 | 2017-03-02 | |
| US201762469317P | 2017-03-09 | 2017-03-09 | |
| US201762486876P | 2017-04-18 | 2017-04-18 | |
| PCT/US2018/020154 WO2018160654A2 (en) | 2017-03-02 | 2018-02-28 | Adjuvant treatment of her2-positive breast cancer |
| EP18712044.9A EP3589661B1 (en) | 2017-03-02 | 2018-02-28 | Adjuvant treatment of her2-positive breast cancer |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20240069T1 true HRP20240069T1 (hr) | 2024-03-29 |
Family
ID=61691568
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240069TT HRP20240069T1 (hr) | 2017-03-02 | 2018-02-28 | Adjuvantno liječenje her2-pozitivnog raka dojke |
Country Status (18)
| Country | Link |
|---|---|
| US (3) | US11077189B2 (hr) |
| EP (1) | EP3589661B1 (hr) |
| JP (4) | JP6992081B2 (hr) |
| KR (4) | KR102417583B1 (hr) |
| CN (5) | CN110337450B (hr) |
| AU (3) | AU2018227788B2 (hr) |
| CA (1) | CA3048918C (hr) |
| DK (1) | DK3589661T3 (hr) |
| FI (1) | FI3589661T3 (hr) |
| HR (1) | HRP20240069T1 (hr) |
| IL (3) | IL289297B2 (hr) |
| LT (1) | LT3589661T (hr) |
| MX (2) | MX2019010296A (hr) |
| PT (1) | PT3589661T (hr) |
| RS (1) | RS65204B1 (hr) |
| SI (1) | SI3589661T1 (hr) |
| TW (2) | TWI792743B (hr) |
| WO (1) | WO2018160654A2 (hr) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI1210115T1 (sl) * | 1999-08-27 | 2009-12-31 | Genentech Inc | Doziranja za zdravljenje s protitelesi proti ErbB2 |
| TWI472339B (zh) | 2008-01-30 | 2015-02-11 | Genentech Inc | 包含結合至ｈｅｒ２結構域ii之抗體及其酸性變異體的組合物 |
| BRPI0812682A2 (pt) | 2008-06-16 | 2010-06-22 | Genentech Inc | tratamento de cáncer de mama metastático |
| US10380152B2 (en) * | 2016-01-19 | 2019-08-13 | International Business Machines Corporation | Cognitive system comparison and recommendation engine |
| JP6741875B2 (ja) | 2017-01-17 | 2020-08-19 | ジェネンテック， インコーポレイテッド | 皮下ｈｅｒ２抗体製剤 |
| KR102417583B1 (ko) | 2017-03-02 | 2022-07-07 | 제넨테크, 인크. | Her2-양성 유방암 어쥬번트 치료 |
| MX2021011278A (es) * | 2019-03-25 | 2022-03-17 | Alteogen Inc | Composicion farmaceutica para inyeccion subcutanea que comprende una variante de hialuronidasa humana ph20 y un farmaco. |
| US20220233563A1 (en) * | 2019-03-29 | 2022-07-28 | The Board Of Trustees Of The Leland Stanford Junior University | Methods of Treatments Based Upon Anthracycline Responsiveness |
| CA3137480A1 (en) * | 2019-05-02 | 2020-11-05 | Mab Discovery Gmbh | Combination of her2 antibodies |
| CN117224689B (zh) * | 2023-11-16 | 2024-02-23 | 上海复宏汉霖生物技术股份有限公司 | 联合抗her2抗体和化疗剂治疗胃癌的用途 |
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