RU2010142390A - Комбинации конъюгата анти-her2-антитело-лекарственное средство и химиотерапевтических средств и способы применения - Google Patents

Комбинации конъюгата анти-her2-антитело-лекарственное средство и химиотерапевтических средств и способы применения Download PDF

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RU2010142390A
RU2010142390A RU2010142390/15A RU2010142390A RU2010142390A RU 2010142390 A RU2010142390 A RU 2010142390A RU 2010142390/15 A RU2010142390/15 A RU 2010142390/15A RU 2010142390 A RU2010142390 A RU 2010142390A RU 2010142390 A RU2010142390 A RU 2010142390A
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chemotherapeutic agent
cancer
carcinoma
trastuzumab
mcc
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RU2010142390/15A
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RU2510272C2 (ru
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Лини БЕРРИ (US)
Лини БЕРРИ
Гейл Льюис ФИЛЛИПС (US)
Гейл Льюис ФИЛЛИПС
Марк Кс. СЛИВКОВСКИ (US)
Марк Кс. СЛИВКОВСКИ
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Дженентек, Инк. (Us)
Дженентек, Инк.
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Abstract

1. Способ лечения гиперпролиферативного нарушения, включающий введение терапевтической комбинации в виде комбинированной композиции или поочередно млекопитающему, в котором терапевтическая комбинация содержит терапевтически эффективное количество трастузумаба-МСС-DM1 и терапевтически эффективное количество химиотерапевтического средства, выбранного из антитела-ингибитора димеризации HER2, антитела к VEGF, 5-FU, карбоплатина, лапатиниба, ABT-869, доцетаксела, GDC-0941 и GNE-390. ! 2. Способ по п.1, в котором антителом-ингибитором димеризации HER2 является пертузумаб. ! 3. Способ по п.1, в котором антителом к VEGF является бевацизумаб. ! 4. Способ по п.1, в котором химиотерапевтическим средством является 5-FU. ! 5. Способ по п.1, в котором химиотерапевтическим средством является карбоплатин. ! 6. Способ по п.1, в котором химиотерапевтическим средством является лапатиниб. ! 7. Способ по п.1, в котором химиотерапевтическим средством является АВТ-869. ! 8. Способ по п.1, в котором химиотерапевтическим средством является доцетаксел. ! 9. Способ по п.1, в котором химиотерапевтическим средством является GDC-0941. ! 10. Способ по п.1, в котором химиотерапевтическим средством является GNE-390. ! 11. Способ по п.1, в котором терапевтически эффективное количество трастузумаба-МСС-DM1 и терапевтически эффективное количество химиотерапевтического средства вводят в виде комбинированной композиции. ! 12. Способ по п.1, в котором терапевтически эффективное количество трастузумаба-МСС-DM1 и терапевтически эффективное количество химиотерапевтического средства вводят поочередно. ! 13. Способ по п.12, в котором млекопитающему вводят химиотерапевтическое средство и затем впоследс

Claims (32)

1. Способ лечения гиперпролиферативного нарушения, включающий введение терапевтической комбинации в виде комбинированной композиции или поочередно млекопитающему, в котором терапевтическая комбинация содержит терапевтически эффективное количество трастузумаба-МСС-DM1 и терапевтически эффективное количество химиотерапевтического средства, выбранного из антитела-ингибитора димеризации HER2, антитела к VEGF, 5-FU, карбоплатина, лапатиниба, ABT-869, доцетаксела, GDC-0941 и GNE-390.
2. Способ по п.1, в котором антителом-ингибитором димеризации HER2 является пертузумаб.
3. Способ по п.1, в котором антителом к VEGF является бевацизумаб.
4. Способ по п.1, в котором химиотерапевтическим средством является 5-FU.
5. Способ по п.1, в котором химиотерапевтическим средством является карбоплатин.
6. Способ по п.1, в котором химиотерапевтическим средством является лапатиниб.
7. Способ по п.1, в котором химиотерапевтическим средством является АВТ-869.
8. Способ по п.1, в котором химиотерапевтическим средством является доцетаксел.
9. Способ по п.1, в котором химиотерапевтическим средством является GDC-0941.
10. Способ по п.1, в котором химиотерапевтическим средством является GNE-390.
11. Способ по п.1, в котором терапевтически эффективное количество трастузумаба-МСС-DM1 и терапевтически эффективное количество химиотерапевтического средства вводят в виде комбинированной композиции.
12. Способ по п.1, в котором терапевтически эффективное количество трастузумаба-МСС-DM1 и терапевтически эффективное количество химиотерапевтического средства вводят поочередно.
13. Способ по п.12, в котором млекопитающему вводят химиотерапевтическое средство и затем впоследствии вводят трастузумаб-MCC-DM1.
14. Способ по п.12, в котором терапевтическую комбинацию вводят человеку с гиперпролиферативным нарушением с интервалами примерно три недели.
15. Способ по п.12, в котором трастузумаб-MCC-DM1 вводят человеку с гиперпролиферативным нарушением с интервалами примерно от одной недели до трех недель.
16. Способ по п.1, в котором введение терапевтической комбинации приводит к синергическому эффекту.
17. Способ по п.1, в котором гиперпролиферативное нарушение представляет собой злокачественную опухоль.
18. Способ по п.17, в котором гиперпролиферативное нарушение представляет собой злокачественную опухоль, экспрессирующую ErbB2.
19. Способ по п.17, в котором злокачественная опухоль представляет собой рак молочной железы, яичников, шейки матки, предстательной железы, яичка, органов мочеполовой системы, пищевода, гортани, глиобластому, нейробластому, рак желудка, кожи, кератоакантому, рак легких, плоскоклеточную карциному, крупноклеточную карциному, немелкоклеточную карциному легких (NSCLC), мелкоклеточную карциному, аденокарциному легких, рак кости, рак ободочной кишки, аденому, рак поджелудочной железы, аденокарциному, рак щитовидной железы, фолликулярную карциному, недифференцированную карциному, папиллярную карциному, семиному, меланому, саркому, карциному мочевого пузыря, карциному печени и желчных протоков, карциному почек, рак поджелудочной железы, миелоидные нарушения, лимфому, рак волосистых клеток, рак щечного кармана, носоглотки, глотки, рак губ, языка, ротовой полости, тонкого кишечника, рак ободочной-прямой кишки, толстого кишечника, прямой кишки, мозга и центральной нервной системы, ходжкинскую лимфому и лейкоз.
20. Способ по п.1, в котором количество трастузумаба-MCC-DM1 и количество химиотерапевтического средства составляет для каждого примерно от 1 мг до примерно 1000 мг.
21. Способ по п.1, в котором количество трастузумаба-MCC-DM1 и количество химиотерапевтического средства находятся в соотношении от примерно 1:10 до примерно 10:1 по массе.
22. Способ по п.1, в котором млекопитающим является пациент с положительной реакций на HER2.
23. Способ по п.1, в котором пациент с положительной реакций на HER2 получал терапию трастузумабом или лапатинибом.
24. Фармацевтическая композиция, содержащая трастузумаб-МСС-DM1, химиотерапевтическое средство, выбранное из антитела-ингибитора димеризации HER2, антитела к VEGF, 5-FU, карбоплатина, лапатиниба, ABT-869, доцетаксела, GDC-0941 и GNE-390; и один или несколько фармацевтически приемлемых носителей, регуляторов сыпучести, разбавителей или наполнителей.
25. Фармацевтическая композиция по п.24, содержащая фармацевтически приемлемый регулятор сыпучести, выбранный из диоксида кремния, порошкообразной целлюлозы, микрокристаллической целлюлозы, стеаратов металлов, алюмосиликата натрия, бензоата натрия, карбоната кальция, силиката кальция, кукурузного крахмала, карбоната магния, не содержащего примеси асбеста талька, стеаровета C, крахмала, крахмала 1500, лаурилсульфата магния, оксида магния и их комбинаций.
26. Фармацевтическая композиция по п.24, в которой количество трастузумаба-MCC-DM1 и количество химиотерапевтического средства составляет для каждого от примерно 1 мг до примерно 1000 мг.
27. Фармацевтическая композиция по п.24, в которой количество трастузумаба-MCC-DM1 и количество химиотерапевтического средства находятся в соотношении от примерно 1:10 до примерно 10:1 по массе.
28. Применение терапевтической комбинации в производстве лекарственного средства для лечения злокачественной опухоли, выбранной из рака молочной железы, яичников, шейки матки, предстательной железы, яичка, органов мочеполовой системы, пищевода, гортани, глиобластомы, нейробластомы, рака желудка, кожи, кератоакантомы, рака легких, плоскоклеточной карциномы, крупноклеточной карциномы, немелкоклеточной карциномы легких (NSCLC), мелкоклеточной карциномы, аденокарциномы легких, рака кости, рака ободочной кишки, аденомы, рака поджелудочной железы, аденокарциномы, рака щитовидной железы, фолликулярной карциномы, недифференцированной карциномы, папиллярной карциномы, семиномы, меланомы, саркомы, карциномы мочевого пузыря, карциномы печени и желчных протоков, карциномы почек, рака поджелудочной железы, миелоидных нарушений, лимфомы, рака волосистых клеток, рака щечного кармана, носоглотки, глотки, рака губ, языка, ротовой полости, тонкого кишечника, рака ободочной-прямой кишки, толстого кишечника, прямой кишки, мозга и центральной нервной системы, ходжкинской лимфомы и лейкоза;
где терапевтическую комбинацию вводят млекопитающему в виде комбинированной композиции или поочередно, и она содержит терапевтически эффективное количество трастузумаба-MCC-DM1 и терапевтически эффективное количество химиотерапевтического средства, выбранного из антитела-ингибитора димеризации HER2, антитела к VEGF, 5-FU, карбоплатина, лапатиниба, ABT-869, доцетаксела, GDC-0941 и GNE-390.
29. Изделие для лечения гиперпролиферативного нарушения, содержащее:
(а) терапевтическую комбинацию, вводимую млекопитающему в виде комбинированной композиции или поочередно, и содержащую терапевтически эффективное количество трастузумаба-MCC-DM1 и терапевтически эффективное количество химиотерапевтического средства, выбранного из антитела-ингибитора димеризации HER2, антитела к VEGF, 5-FU, карбоплатина, лапатиниба, ABT-869, доцетаксела, GDC-0941 и GNE-390; и
(b) инструкции по применению.
30. Способ определения соединений для применения в комбинации для лечения злокачественной опухоли, включающий:
(а) введение терапевтической комбинации трастузумаба-MCC-DM1 и химиотерапевтического средства, выбранного из антитела-ингибитора димеризации HER2, антитела к VEGF, 5-FU, карбоплатина, лапатиниба, ABT-869, доцетаксела, GDC-0941 и GNE-390, в клетки злокачественной опухоли молочной железы с амплификацией HER2; и
(b) определение ингибирования пролиферации клеток, где доброкачественные и злокачественные клетки молочной железы различаются по жизнеспособности клеток.
31. Способ по п.30, в котором клетки злокачественной опухоли молочной железы с амплификацией HER2 представляют клетки ВТ-474.
32. Способ определения терапевтической комбинации для применения в лечении злокачественной опухоли, включающий:
(а) обработку линии опухолевых клеток в условиях in vitro терапевтической комбинацией трастузумаба-MCC-DM1 и химиотерапевтического средства, выбранного из антитела-ингибитора димеризации HER2, антитела к VEGF, 5-FU, карбоплатина, лапатиниба, ABT-869, доцетаксела, GDC-0941 и GNE-390; и
(b) определение синергического и несинергического эффекта;
посредством чего определяют синергическую терапевтическую комбинацию для лечения рака.
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