RU2019125238A - Препараты антител против her2 для подкожного введения - Google Patents
Препараты антител против her2 для подкожного введения Download PDFInfo
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- RU2019125238A RU2019125238A RU2019125238A RU2019125238A RU2019125238A RU 2019125238 A RU2019125238 A RU 2019125238A RU 2019125238 A RU2019125238 A RU 2019125238A RU 2019125238 A RU2019125238 A RU 2019125238A RU 2019125238 A RU2019125238 A RU 2019125238A
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- Prior art keywords
- cancer
- pertuzumab
- administered
- trastuzumab
- pharmaceutical composition
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- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 title claims 5
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 title claims 5
- 238000007920 subcutaneous administration Methods 0.000 title claims 3
- 229960002087 pertuzumab Drugs 0.000 claims 12
- 206010006187 Breast cancer Diseases 0.000 claims 7
- 208000026310 Breast neoplasm Diseases 0.000 claims 7
- 206010028980 Neoplasm Diseases 0.000 claims 7
- 201000011510 cancer Diseases 0.000 claims 7
- 239000007788 liquid Substances 0.000 claims 7
- 239000008194 pharmaceutical composition Substances 0.000 claims 7
- 229960000575 trastuzumab Drugs 0.000 claims 7
- 206010055113 Breast cancer metastatic Diseases 0.000 claims 4
- 239000002246 antineoplastic agent Substances 0.000 claims 4
- 229940127089 cytotoxic agent Drugs 0.000 claims 4
- 229940123237 Taxane Drugs 0.000 claims 3
- 229940045799 anthracyclines and related substance Drugs 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 238000012423 maintenance Methods 0.000 claims 3
- 229940120723 recombinant human hyaluronidase Drugs 0.000 claims 3
- DKPFODGZWDEEBT-QFIAKTPHSA-N taxane Chemical class C([C@]1(C)CCC[C@@H](C)[C@H]1C1)C[C@H]2[C@H](C)CC[C@@H]1C2(C)C DKPFODGZWDEEBT-QFIAKTPHSA-N 0.000 claims 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 2
- 206010005003 Bladder cancer Diseases 0.000 claims 2
- 206010009944 Colon cancer Diseases 0.000 claims 2
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 2
- 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 2
- 201000001342 Fallopian tube cancer Diseases 0.000 claims 2
- 208000013452 Fallopian tube neoplasm Diseases 0.000 claims 2
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 2
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 2
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 2
- 201000009036 biliary tract cancer Diseases 0.000 claims 2
- 208000020790 biliary tract neoplasm Diseases 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 201000005202 lung cancer Diseases 0.000 claims 2
- 208000020816 lung neoplasm Diseases 0.000 claims 2
- 229930182817 methionine Natural products 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 201000002628 peritoneum cancer Diseases 0.000 claims 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 2
- 229940068977 polysorbate 20 Drugs 0.000 claims 2
- 239000008227 sterile water for injection Substances 0.000 claims 2
- 238000010254 subcutaneous injection Methods 0.000 claims 2
- 239000007929 subcutaneous injection Substances 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 229940124597 therapeutic agent Drugs 0.000 claims 2
- 201000005112 urinary bladder cancer Diseases 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 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 1
- STQGQHZAVUOBTE-UHFFFAOYSA-N 7-Cyan-hept-2t-en-4,6-diinsaeure Natural products C1=2C(O)=C3C(=O)C=4C(OC)=CC=CC=4C(=O)C3=C(O)C=2CC(O)(C(C)=O)CC1OC1CC(N)C(O)C(C)O1 STQGQHZAVUOBTE-UHFFFAOYSA-N 0.000 claims 1
- 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 1
- 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 1
- 229930012538 Paclitaxel Natural products 0.000 claims 1
- 229960000975 daunorubicin Drugs 0.000 claims 1
- STQGQHZAVUOBTE-VGBVRHCVSA-N daunorubicin 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(C)=O)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 STQGQHZAVUOBTE-VGBVRHCVSA-N 0.000 claims 1
- 229960003668 docetaxel Drugs 0.000 claims 1
- 229960004679 doxorubicin Drugs 0.000 claims 1
- 229960001904 epirubicin Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229960001592 paclitaxel Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 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 1
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- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
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Claims (30)
1. Жидкая фармацевтическая композиция, содержащая 600 мг пертузумаба в концентрации 60 мг/мл, 600 мг трастузумаба в концентрации 60 мг/мл, 2000 Ед/мл рекомбинантной гиалуронидазы человека (rHuPH20), 20 мМ His-HCl pH 5,5, 105 мМ трегалозы, 100 мМ сахарозы, 0,04% полисорбата 20, 10 мМ метионина и стерильную воду для инъекций до общего объема 10 мл.
2. Жидкая фармацевтическая композиция по п. 1, содержащаяся во флаконе объемом 15 мл.
3. Жидкая фармацевтическая композиция, содержащая 1200 мг пертузумаба в концентрации 80 мг/мл, 600 мг трастузумаба в концентрации 40 мг/мл, 2000 Ед/мл рекомбинантной гиалуронидазы человека (rHuPH20), 20 мМ His-HCl pH 5,5, 70 мМ трегалозы, 133 мМ сахарозы, 0,04% полисорбата 20, 10 мМ метионина и стерильную воду для инъекций до общего объема 15 мл.
4. Жидкая фармацевтическая композиция по п. 3, содержащаяся во флаконе объемом 20 мл.
5. Изделие, содержащее жидкую фармацевтическую композицию по любому из пп. 1-4.
6. Изделие по п. 5, дополнительно содержащее листок-вкладыш с инструкциями по подкожному введению жидкой фармацевтической композиции, содержащейся в изделии, человеку с HER2-положительным онкологическим заболеванием.
7. Изделие по п. 6, отличающееся тем, что HER2-положительное онкологическое заболевание выбрано из группы, состоящей из рака молочной железы, перитонеального рака, рака маточной трубы, рака легких, колоректального рака, рака желчных путей и рака мочевого пузыря.
8. Изделие по п. 7, отличающееся тем, что онкологическое заболевание представляет собой рак молочной железы.
9. Изделие по п. 8, отличающееся тем, что рак молочной железы представляет собой ранний рак молочной железы (РРМЖ) или метастатический рак молочной железы (МРМЖ).
10. Применение пертузумаба в производстве лекарственного средства для лечения HER2-положительного онкологического заболевания, при этом пертузумаб вводят подкожно в фиксированной нагрузочной дозе 1200 мг с последующей, по меньшей мере, одной поддерживающей дозой 600 мг.
11. Применение по п. 10, в котором после введения нагрузочной дозы следует введение нескольких поддерживающих доз.
12. Применение по п. 11, в котором первую поддерживающую дозу пертузумаба вводят указанному субъекту, представляющему собой человека, спустя приблизительно две недели или приблизительно три недели после введения нагрузочной дозы пертузумаба.
13. Применение по любому из п.11 или п.12, в котором фиксированные дозы пертузумаба вводят указанному субъекту, представляющему собой человека, приблизительно каждые 2 недели или приблизительно каждые 3 недели.
14. Применение по п. 13, в котором фиксированные дозы пертузумаба вводят приблизительно каждые 3 недели.
15. Применение по п. 10, в котором HER2-положительное онкологическое заболевание выбрано из группы, состоящей из рака молочной железы, перитонеального рака, рака маточной трубы, рака легких, колоректального рака, рака желчных путей и рака мочевого пузыря.
16. Применение по п. 15, в котором онкологическое заболевание представляет собой рак молочной железы.
17. Применение по п. 16, в котором онкологическое заболевание представляет собой ранний рак молочной железы (РРМЖ) или метастатический рак молочной железы (МРМЖ).
18. Применение по любому из пп. 10-17, включающее введение второго терапевтического агента пациенту.
19. Применение по п. 18, в котором второй терапевтический агент представляет собой другое антитело против HER2.
20. Применение по п. 19, в котором другое антитело против HER2 представляет собой трастузумаб.
21. Применение по п. 20, в котором фиксированную дозу пертузумаба вводят подкожно в комбинации с подкожно вводимым трастузумабом.
22. Применение по п. 21, в котором фиксированную дозу пертузумаба и трастузумаба вводят совместно подкожно в виде двух отдельных подкожных инъекций.
23. Применение по п. 21, в котором фиксированную дозу пертузумаба смешивают с фиксированной дозой трастузумаба и вводят в виде единой подкожной инъекции.
24. Применение по п. 21, в котором фиксированную дозу пертузумаба и фиксированную дозу трастузумаба вводят в виде одного совместного препарата для подкожного введения.
25. Применение по п.21, в котором совместный препарат дополнительно включает рекомбинантную гиалуронидазу человека (rHuPH20).
26. Применение по п. 25, в котором совместный препарат представляет собой жидкую фармацевтическую композицию по любому из пп. 1-4.
27. Применение по п. 20, дополнительно включающее введение химиотерапевтического агента.
28. Применение по п. 27, в котором химиотерапевтический агент представляет собой таксан или антрациклин.
29. Применение по п. 28, в котором химиотерапевтический агент представляет собой таксан и таксан содержит паклитаксел или доцетаксел.
30. Применение по п. 28, в котором химиотерапевтический агент представляет собой антрациклин и антрациклин содержит даунорубицин, доксорубицин или эпирубицин.
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