RU2013106216A - BIOMARKERS OF CHRONIC Lymphocytic Leukemia - Google Patents

BIOMARKERS OF CHRONIC Lymphocytic Leukemia Download PDF

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RU2013106216A
RU2013106216A RU2013106216/15A RU2013106216A RU2013106216A RU 2013106216 A RU2013106216 A RU 2013106216A RU 2013106216/15 A RU2013106216/15 A RU 2013106216/15A RU 2013106216 A RU2013106216 A RU 2013106216A RU 2013106216 A RU2013106216 A RU 2013106216A
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cll
biomarker
drug
pi3k
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Дэвид ДОРНАН
Гийметт ДЮШАТО-НГУЙЕН
Три Цюан НГУЙЕН
Джузеппе ПАЛЕРМО
Мартин ВАЙССЕР
Жу-Фан ЕХ
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Ф. Хоффманн-Ля Рош Аг
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Abstract

1. Способ лечения пациента с хронической лимфоцитарной лейкемией (CLL), включающий введение пациенту терапевтически эффективного количества лекарственного средства против CLL, если было обнаружено, что пациент имеет повышенное количество одного или более чем одного биомаркера, выбранного из миРНК-151 3p (микроРНК151 3p), миРНК409 3p и РТК2.2. Способ по п.1, где лекарственное средство против CLL индуцирует сигнализацию FAK (киназа фокальной адгезии) или гомотипическую адгезию.3. Способ по п.1, где лекарственное средство против CLL представляет собой антагонист B-клеток.4. Способ по п.1, где лекарственное средство против CLL представляет собой антитело против CD20.5. Способ по п.4, где антитело против CD20 является гуманизированным, человеческим или химерным антителом против CD20.6. Способ по п.4, где антитело против CD20 выбрано из группы, состоящей из ритуксимаба, офатумумаба, GA101, SBI-087, велтузумаба и AME-133.7. Способ по п.6, где антитело против CD20 представляет собой ритуксимаб.8. Способ по п.1, где пациент имеет большую выживаемость без прогрессирования заболевания (PFS) относительно пациента, который не имеет повышенного количества биомаркера.9. Способ по п.1, дополнительно включающий введение пациенту химиотерапии.10. Способ по п.9, где химиотерапия включает циклофосфамид и флударабин.11. Способ по п.1, где пациент имеет повышенное количество миРНК151 3p.12. Способ по п.1, где пациент имеет повышенное количество миРНК409 3p.13. Способ по п.1, где пациент имеет повышенное количество РТК2 (протеинтирозинкиназа 2).14. Способ по п.1, где количество биомаркера оценивается путем профилирования генной экспрессии.15. Способ по п.14, где профилирование генной экспрессии включает п1. A method of treating a patient with chronic lymphocytic leukemia (CLL), comprising administering to the patient a therapeutically effective amount of an anti-CLL drug if it is found that the patient has an increased amount of one or more biomarkers selected from siRNA-151 3p (miRNA151 3p) , siRNA409 3p and PTK2.2. The method of claim 1, wherein the anti-CLL drug induces FAK (focal adhesion kinase) signaling or homotypic adhesion. The method of claim 1, wherein the anti-CLL drug is a B-cell antagonist. The method of claim 1, wherein the anti-CLL drug is an anti-CD20.5 antibody. The method of claim 4, wherein the anti-CD20 antibody is a humanized, human, or chimeric anti-CD20 antibody. The method of claim 4, wherein the anti-CD20 antibody is selected from the group consisting of rituximab, ofatumumab, GA101, SBI-087, veltuzumab, and AME-133.7. The method of claim 6, wherein the anti-CD20 antibody is rituximab. The method of claim 1, wherein the patient has greater disease progression-free survival (PFS) relative to a patient who does not have an increased amount of biomarker. The method of claim 1, further comprising administering chemotherapy to the patient. The method of claim 9, wherein the chemotherapy includes cyclophosphamide and fludarabine. The method of claim 1, wherein the patient has an increased amount of siRNA151 3p.12. The method according to claim 1, where the patient has an increased amount of siRNA409 3p.13. The method of claim 1, wherein the patient has an increased amount of PTK2 (protein tyrosine kinase 2). The method of claim 1, wherein the amount of biomarker is evaluated by profiling gene expression. The method of claim 14, wherein profiling the gene expression comprises

Claims (38)

1. Способ лечения пациента с хронической лимфоцитарной лейкемией (CLL), включающий введение пациенту терапевтически эффективного количества лекарственного средства против CLL, если было обнаружено, что пациент имеет повышенное количество одного или более чем одного биомаркера, выбранного из миРНК-151 3p (микроРНК151 3p), миРНК409 3p и РТК2.1. A method of treating a patient with chronic lymphocytic leukemia (CLL), comprising administering to the patient a therapeutically effective amount of an anti-CLL drug if it is found that the patient has an increased amount of one or more biomarkers selected from siRNA-151 3p (miRNA151 3p) , siRNA409 3p and PTK2. 2. Способ по п.1, где лекарственное средство против CLL индуцирует сигнализацию FAK (киназа фокальной адгезии) или гомотипическую адгезию.2. The method according to claim 1, where the anti-CLL drug induces signaling FAK (focal adhesion kinase) or homotypic adhesion. 3. Способ по п.1, где лекарственное средство против CLL представляет собой антагонист B-клеток.3. The method according to claim 1, where the anti-CLL drug is a B-cell antagonist. 4. Способ по п.1, где лекарственное средство против CLL представляет собой антитело против CD20.4. The method according to claim 1, where the anti-CLL drug is an anti-CD20 antibody. 5. Способ по п.4, где антитело против CD20 является гуманизированным, человеческим или химерным антителом против CD20.5. The method according to claim 4, where the anti-CD20 antibody is a humanized, human or chimeric anti-CD20 antibody. 6. Способ по п.4, где антитело против CD20 выбрано из группы, состоящей из ритуксимаба, офатумумаба, GA101, SBI-087, велтузумаба и AME-133.6. The method according to claim 4, where the anti-CD20 antibody is selected from the group consisting of rituximab, ofatumumab, GA101, SBI-087, veltuzumab and AME-133. 7. Способ по п.6, где антитело против CD20 представляет собой ритуксимаб.7. The method according to claim 6, where the anti-CD20 antibody is rituximab. 8. Способ по п.1, где пациент имеет большую выживаемость без прогрессирования заболевания (PFS) относительно пациента, который не имеет повышенного количества биомаркера.8. The method according to claim 1, where the patient has greater survival without progression of the disease (PFS) relative to a patient who does not have an increased amount of biomarker. 9. Способ по п.1, дополнительно включающий введение пациенту химиотерапии.9. The method according to claim 1, further comprising administering chemotherapy to the patient. 10. Способ по п.9, где химиотерапия включает циклофосфамид и флударабин.10. The method according to claim 9, where the chemotherapy includes cyclophosphamide and fludarabine. 11. Способ по п.1, где пациент имеет повышенное количество миРНК151 3p.11. The method according to claim 1, where the patient has an increased amount of siRNA151 3p. 12. Способ по п.1, где пациент имеет повышенное количество миРНК409 3p.12. The method according to claim 1, where the patient has an increased amount of siRNA409 3p. 13. Способ по п.1, где пациент имеет повышенное количество РТК2 (протеинтирозинкиназа 2).13. The method according to claim 1, where the patient has an increased amount of PTK2 (protein tyrosine kinase 2). 14. Способ по п.1, где количество биомаркера оценивается путем профилирования генной экспрессии.14. The method according to claim 1, where the amount of biomarker is estimated by profiling gene expression. 15. Способ по п.14, где профилирование генной экспрессии включает полимеразную цепную реакцию (ПЦР).15. The method according to 14, where the profiling of gene expression includes a polymerase chain reaction (PCR). 16. Способ по п.15, где ПЦР включает количественную ПЦР в реальном времени (кПЦР-РВ).16. The method according to clause 15, where PCR includes quantitative real-time PCR (qPCR-RV). 17. Способ по любому из пп.1-16, включающий тестирование образца от пациента на экспрессию биомаркера.17. The method according to any one of claims 1 to 16, comprising testing a sample from a patient for expression of a biomarker. 18. Способ по п.17, где образец содержит одноядерные клетки периферической крови (PBMC).18. The method according to 17, where the sample contains mononuclear cells of peripheral blood (PBMC). 19. Способ лечения пациента с хронической лимфоцитарной лейкемией (CLL), включающий введение пациенту терапевтически эффективного количества комбинации ритуксимаба, флударабина и циклофосфамида, если было обнаружено, что пациент имеет повышенное количество одного или более чем одного биомаркера, выбранного из миРНК151 3p, миРНК409 3p и РТК2.19. A method of treating a patient with chronic lymphocytic leukemia (CLL), comprising administering to the patient a therapeutically effective amount of a combination of rituximab, fludarabine and cyclophosphamide, if the patient has been found to have an increased amount of one or more biomarkers selected from siRNA151 3p, siRNA409 3p and RTK2. 20. Способ лечения пациента с хронической лимфоцитарной лейкемией (CLL), включающий введение пациенту терапевтически эффективного количества лекарственного средства против CLL, отличного от ритуксимаба, если было обнаружено, что пациент имеет пониженное количество одного или более чем одного биомаркера, выбранного из миРНК151 3p, миРНК409 3p и РТК2.20. A method of treating a patient with chronic lymphocytic leukemia (CLL), comprising administering to the patient a therapeutically effective amount of an anti-CLL drug other than rituximab, if it has been found that the patient has a reduced amount of one or more biomarkers selected from siRNA151 3p, siRNA409 3p and RTK2. 21. Способ выбора терапии для пациента с хронической лимфоцитарной лейкемией (CLL), включающий определение экспрессии биомаркера, выбранного из миРНК151 3p, миРНК409 3p, РТК2 и PI3K (фосфатидилинозитол-3-киназа) в образце от пациента, и выбор лекарственного средства против CLL на основе уровня экспрессии биомаркера.21. A method for selecting a therapy for a patient with chronic lymphocytic leukemia (CLL), comprising determining expression of a biomarker selected from siRNA151 3p, siRNA409 3p, PTK2, and PI3K (phosphatidylinositol-3-kinase) in a patient sample, and selecting a drug against CLL on based on the level of biomarker expression. 22. Способ по п.21, где пациента выбирают для лечения лекарственным средством против CLL, если образец раковой опухоли экспрессирует биомаркер на повышенном уровне.22. The method according to item 21, where the patient is selected for treatment with an anti-CLL drug if the cancer sample expresses a biomarker at an elevated level. 23. Способ по п.21, где лекарственное средство против CLL индуцирует сигнализацию FAK или гомотипическую адгезию.23. The method of claim 21, wherein the anti-CLL drug induces FAK signaling or homotypic adhesion. 24. Способ по п.21, где лекарственное средство против CLL представляет собой антагонист B-клеток.24. The method of claim 21, wherein the anti-CLL drug is a B-cell antagonist. 25. Способ по п.21, где лекарственное средство против CLL представляет собой антитело против CD20.25. The method according to item 21, where the anti-CLL drug is an anti-CD20 antibody. 26. Способ по п.21, где пациента выбирают для лечения лекарственным средством против CLL, отличным от ритуксимаба, если образец раковой опухоли экспрессирует биомаркер на пониженном уровне.26. The method according to item 21, where the patient is selected for treatment with an anti-CLL drug other than rituximab, if the cancer sample expresses a biomarker at a reduced level. 27. Диагностический набор, содержащий один или более чем один реактив для определения экспрессии биомаркера, выбранного из миРНК151 3p, миРНК409 3p, РТК2 и PI3K в образце от пациента с CLL.27. A diagnostic kit containing one or more reagents for determining expression of a biomarker selected from siRNA151 3p, siRNA409 3p, PTK2, and PI3K in a sample from a patient with CLL. 28. Диагностический набор по п.27, дополнительно содержащий инструкции для применения набора для выбора лекарственного средства против CLL для лечения пациента с CLL.28. The diagnostic kit of claim 27, further comprising instructions for using the anti-CLL drug selection kit for treating a patient with CLL. 29. Диагностический набор по п.27 или п.28, где один или более чем один реактив содержит пару ДНК-праймеров и зонд для детектирования биомаркера.29. The diagnostic kit according to item 27 or item 28, where one or more than one reagent contains a pair of DNA primers and a probe for detecting a biomarker. 30. Изделие, содержащее совместно упакованные лекарственное средство против CLL в фармацевтически приемлемом носителе и листок-вкладыш в упаковку, указывающий то, что лекарственное средство против CLL предназначено для лечения пациента с хронической лимфоцитарной лейкемией (CLL) на основе экспрессии одного или более чем одного биомаркера, выбранного из миРНК151 3p, миРНК409 3p, РТК2 и PI3K.30. A product containing a co-packaged anti-CLL drug in a pharmaceutically acceptable carrier and a package leaflet indicating that the anti-CLL drug is intended to treat a patient with chronic lymphocytic leukemia (CLL) based on the expression of one or more biomarkers selected from siRNA151 3p, siRNA409 3p, PTK2 and PI3K. 31. Способ изготовления изделия, включающий объединение в упаковке фармацевтической композиции, содержащей лекарственное средство против CLL и листок-вкладыш в упаковку, указывающий то, что фармацевтическая композиция предназначена для лечения пациента с хронической лимфоцитарной лейкемией (CLL) на основе экспрессии одного или более чем одного биомаркера, выбранного из миРНК151 3p, миРНК409 3p, РТК2 и PI3K.31. A method of manufacturing a product, comprising combining in a package a pharmaceutical composition containing an anti-CLL drug and a package insert indicating that the pharmaceutical composition is intended to treat a patient with chronic lymphocytic leukemia (CLL) based on the expression of one or more than one a biomarker selected from siRNA151 3p, siRNA409 3p, PTK2 and PI3K. 32. Способ рекламы лекарственного средства против CLL, включающий продвижение для целевой аудитории применения лекарственного средства против CLL для лечения пациента с хронической лимфоцитарной лейкемией (CLL) на основе экспрессии одного или более чем одного биомаркера, выбранного из миРНК151 3p, миРНК409 3p, РТК2 и PI3K.32. A method of advertising an anti-CLL drug, comprising promoting for the target audience the use of the anti-CLL drug for treating a patient with chronic lymphocytic leukemia (CLL) based on the expression of one or more biomarkers selected from siRNA151 3p, siRNA409 3p, PTK2 and PI3K . 33. Способ лечения пациента с хронической лимфоцитарной лейкемией (CLL), включающий введение терапевтически эффективного количества лекарственного средства против CLL пациенту, если было обнаружено, что пациент имеет пониженный биомаркер PI3K.33. A method of treating a patient with chronic lymphocytic leukemia (CLL), comprising administering a therapeutically effective amount of an anti-CLL drug to a patient, if it has been found that the patient has a reduced PI3K biomarker. 34. Способ по п.33, где биомаркер PI3K включает PIK3R3.34. The method according to p, where the PI3K biomarker includes PIK3R3. 35. Способ лечения пациента с хронической лимфоцитарной лейкемией (CLL), включающий введение пациенту терапевтически эффективного количества комбинации ритуксимаба, флударабина и циклофосфамида, если было обнаружено, что пациент имеет пониженный биомаркер PI3K.35. A method of treating a patient with chronic lymphocytic leukemia (CLL), comprising administering to the patient a therapeutically effective amount of a combination of rituximab, fludarabine and cyclophosphamide if it has been found that the patient has a reduced PI3K biomarker. 36. Способ по п.35, где биомаркер PI3K включает PIK3R3.36. The method according to clause 35, where the PI3K biomarker includes PIK3R3. 37. Способ лечения пациента с хронической лимфоцитарной лейкемией (CLL), включающий введение пациенту терапевтически эффективного количества лекарственного средства против CLL, отличного от ритуксимаба, если было обнаружено, что пациент имеет повышенный биомаркер PI3K.37. A method of treating a patient with chronic lymphocytic leukemia (CLL), comprising administering to the patient a therapeutically effective amount of an anti-CLL drug other than rituximab if the patient has been found to have an increased PI3K biomarker. 38. Способ по п.37, где биомаркер PI3K включает PIK3R3. 38. The method according to clause 37, where the PI3K biomarker includes PIK3R3.
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