RU2007131693A - Введение фиксированных доз her-антител - Google Patents

Введение фиксированных доз her-антител Download PDF

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RU2007131693A
RU2007131693A RU2007131693/14A RU2007131693A RU2007131693A RU 2007131693 A RU2007131693 A RU 2007131693A RU 2007131693/14 A RU2007131693/14 A RU 2007131693/14A RU 2007131693 A RU2007131693 A RU 2007131693A RU 2007131693 A RU2007131693 A RU 2007131693A
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antibody
fixed dose
cancer
malignant tumor
pertuzumab
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RU2007131693/14A
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RU2438705C2 (ru
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Дэвид Е. ЭЛЛИСОН (US)
Дэвид Е. ЭЛЛИСОН
Рене БРЮНО (FR)
Рене Брюно
Цз нь-Фын ЛУ (US)
Цзянь-Фын ЛУ
Чее М. НГ (US)
Чее М. НГ
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Дженентек, Инк. (Us)
Дженентек, Инк.
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    • 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
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
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    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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Claims (40)

1. Способ лечения злокачественной опухоли, включающий в себя введение одной или нескольких фиксированных доз HER-антитела больному человеку в количестве, эффективном для лечения злокачественной опухоли.
2. Способ по п.1, в котором антитело связывается с рецептором HER, выбранным из группы, состоящей из EGFR, HER2 и HER3.
3. Способ по п.2, в котором антитело связывается с HER2.
4. Способ по п.3, в котором HER2-антитело связывается с доменом II внеклеточного домена HER2.
5. Способ по любому из предшествующих пунктов, в котором антитело связывается с местом соединения между доменами I, II и III внеклеточного домена HER2.
6. Способ по п.1, в котором HER-антитело ингибирует гетеродимеризацию HER2 с EGFR или HER3.
7. Способ по п.1, в котором HER-антитело содержит аминокислотные последовательности вариабельного домена легкой цепи и вариабельного домена тяжелой цепи, указанные в SEQ ID No. 3 и 4 соответственно.
8. Способ по п.1, в котором HER-антителом является пертузумаб.
9. Способ по п.1, в котором фиксированная доза находится в диапазоне примерно от 20 мг до 2000 мг HER-антитела.
10. Способ по п.1, в котором фиксированная доза выбрана из группы, состоящей из примерно 420 мг, примерно 525 мг, примерно 840 мг и примерно 1050 мг HER-антитела.
11. Способ по п.10, в котором фиксированная доза составляет примерно 420 мг HER-антитела.
12. Способ по п.10, в котором фиксированная доза составляет примерно 1050 мг HER-антитела.
13. Способ по п.1, в котором фиксированную дозу HER-антитела вводят пациенту примерно один раз в неделю, примерно один раз в 2 недели, примерно один раз в 3 недели или примерно один раз в 4 недели.
14. Способ по п.13, в котором фиксированную дозу HER-антитела вводят пациенту примерно один раз в 3 недели.
15. Способ по п.1, в котором HER-антитело является голым антителом.
16. Способ по п.1, в котором HER-антитело является интактным антителом.
17. Способ по п.1, в котором HER-антитело является фрагментом антитела, содержащим антигенсвязывающую область.
18. Способ по п.1, в котором HER-антитело является гуманизированным или человеческим IgG1-антителом.
19. Способ по п.1, в котором в злокачественной опухоли наблюдается экспрессия, амплификация или активация HER.
20. Способ по п.1, в котором злокачественная опухоль является злокачественной опухолью яичника, брюшины или фаллопиевых труб.
21. Способ по п.1, в котором злокачественной опухолью является метастатический рак молочной железы (MBC).
22. Способ по п.1, в котором злокачественной опухолью является немелкоклеточный рак легкого (NSCLC).
23. Способ по п.1, в котором злокачественной опухолью является рак простаты.
24. Способ по п.1, в котором злокачественной опухолью является рак прямой и ободочной кишки.
25. Способ по п.1, включающий в себя введение пациенту второго терапевтического средства.
26. Способ по п.25, в котором второе терапевтическое средство выбрано из группы, состоящей из химиотерапевтического средства, другого HER-антитела, антитела, направленного против другого связанного с опухолью антигена, противогормонального соединения, кардиопротектора, цитокина, лекарственного средства, направленного к EGFR, антиангиогенного средства, ингибитора тирозинкиназы, ингибитора ЦОГ, нестероидного противовоспалительного лекарственного средства, ингибитора фарнезилтрансферазы, антитела, которое связывает онкофетальный белок CA 125, HER2-вакцины, другой направленной к HER терапии, Raf или ras-ингибитора, инъекции липосом, содержащих доксорубицин·HCl, топотекана, таксана, двойного ингибитора тирозинкиназ, TLK286, EMD-7200, лекарственного средства для лечения тошноты, лекарственного средства для профилактики или лечения сыпи на коже или стандартных средств против акне, лекарственного средства, понижающего температуру тела, и гематопоэтического фактора роста.
27. Способ по п.26, в котором вторым терапевтическим средством является химиотерапевтическое средство.
28. Способ по п.27, в котором химиотерапевтическое средство представляет собой антиметаболитное химиотерапевтическое средство.
29. Способ по п.28, в котором антиметаболитным химиотерапевтическим средством является гемцитабин.
30. Способ по п.26, в котором вторым терапевтическим средством является трастузумаб, эрлотиниб·HCL или бевацизумаб.
31. Способ лечения злокачественной опухоли у больного человека, включающий в себя введение пациенту по меньшей мере одной фиксированной дозы пертузумаба, при этом фиксированная доза выбрана из группы, состоящей из примерно 420 мг, примерно 525 мг, примерно 840 мг и примерно 1050 мг пертузумаба.
32. Способ по п.31, в котором фиксированную дозу пертузумаба вводят пациенту примерно один раз в 3 недели.
33. Способ по п.31 или 32, в котором злокачественная опухоль выбрана из группы, состоящей из рака яичника, рака брюшины, рака фаллопиевых труб, метастатического рака молочной железы (MBC), немелкоклеточного рака легкого (NSCLC), рака простаты и рака прямой и ободочной кишки.
34. Изделие производства, включающее в себя флакон, содержащий фиксированную дозу HER-антитела, при этом фиксированная доза выбрана из группы, состоящей из примерно 420 мг, примерно 525 мг, примерно 840 мг и примерно 1050 мг HER-антитела.
35. Изделие производства по п.34, в котором HER-антителом является пертузумаб.
36. Изделие производства по п.34 или 35, дополнительно содержащее вкладыш в упаковку с инструкциями для пользователя по введению фиксированной дозы пациенту со злокачественной опухолью.
37. Изделие производства по п.36, в котором злокачественная опухоль выбрана из группы, состоящей из рака яичника, рака брюшины, рака фаллопиевых труб, метастатического рака молочной железы (MBC), немелкоклеточного рака легкого (NSCLC), рака простаты и рака прямой и ободочной кишки.
38. Изделие производства по п.36, в котором вкладыш в упаковку содержит дополнительные инструкции для пользователя по введению фиксированной дозы пациенту со злокачественной опухолью, у которого в злокачественной опухоли наблюдается экспрессия, амплификация или активация HER.
39. Изделие производства по п.36, включающее в себя два флакона, при этом первый флакон содержит фиксированную дозу пертузумаба, составляющую примерно 840 мг, а второй флакон содержит фиксированную дозу пертузумаба, составляющую примерно 420 мг.
40. Изделие производства по п.36, включающее в себя два флакона, при этом первый флакон содержит фиксированную дозу пертузумаба, составляющую примерно 1050 мг, а второй флакон содержит фиксированную дозу пертузумаба, составляющую примерно 525 мг.
RU2007131693/15A 2005-01-21 2005-06-15 Введение фиксированных доз her-антител RU2438705C2 (ru)

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