RU2018111205A - Терапевтические комбинации, содержащие анти-folr1 иммуноконъюгаты - Google Patents
Терапевтические комбинации, содержащие анти-folr1 иммуноконъюгаты Download PDFInfo
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- RU2018111205A RU2018111205A RU2018111205A RU2018111205A RU2018111205A RU 2018111205 A RU2018111205 A RU 2018111205A RU 2018111205 A RU2018111205 A RU 2018111205A RU 2018111205 A RU2018111205 A RU 2018111205A RU 2018111205 A RU2018111205 A RU 2018111205A
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- 229940127121 immunoconjugate Drugs 0.000 title claims 17
- 230000001225 therapeutic effect Effects 0.000 title 1
- 238000000034 method Methods 0.000 claims 39
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims 20
- 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 12
- 239000003795 chemical substances by application Substances 0.000 claims 12
- 206010028980 Neoplasm Diseases 0.000 claims 10
- 201000011510 cancer Diseases 0.000 claims 10
- 229910052697 platinum Inorganic materials 0.000 claims 10
- 125000003275 alpha amino acid group Chemical group 0.000 claims 6
- 229960004679 doxorubicin Drugs 0.000 claims 6
- 238000003364 immunohistochemistry Methods 0.000 claims 6
- 239000000427 antigen Substances 0.000 claims 5
- 102000036639 antigens Human genes 0.000 claims 5
- 108091007433 antigens Proteins 0.000 claims 5
- 229960000397 bevacizumab Drugs 0.000 claims 5
- 239000012634 fragment Substances 0.000 claims 5
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 4
- 230000002055 immunohistochemical effect Effects 0.000 claims 4
- FUHCFUVCWLZEDQ-UHFFFAOYSA-N 1-(2,5-dioxopyrrolidin-1-yl)oxy-1-oxo-4-(pyridin-2-yldisulfanyl)butane-2-sulfonic acid Chemical compound O=C1CCC(=O)N1OC(=O)C(S(=O)(=O)O)CCSSC1=CC=CC=N1 FUHCFUVCWLZEDQ-UHFFFAOYSA-N 0.000 claims 3
- 206010033128 Ovarian cancer Diseases 0.000 claims 3
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 3
- 230000037396 body weight Effects 0.000 claims 3
- 229940046159 pegylated liposomal doxorubicin Drugs 0.000 claims 3
- 238000002360 preparation method Methods 0.000 claims 3
- 206010014733 Endometrial cancer Diseases 0.000 claims 2
- 206010014759 Endometrial neoplasm Diseases 0.000 claims 2
- 190000008236 carboplatin Chemical group 0.000 claims 2
- 229960004562 carboplatin Drugs 0.000 claims 2
- 102000006815 folate receptor Human genes 0.000 claims 2
- 108020005243 folate receptor Proteins 0.000 claims 2
- 201000002628 peritoneum cancer Diseases 0.000 claims 2
- 239000013612 plasmid Substances 0.000 claims 2
- 150000003431 steroids Chemical class 0.000 claims 2
- 238000002560 therapeutic procedure Methods 0.000 claims 2
- 208000013452 Fallopian tube neoplasm Diseases 0.000 claims 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 1
- 208000009989 Posterior Leukoencephalopathy Syndrome Diseases 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000003889 eye drop Substances 0.000 claims 1
- 201000001343 fallopian tube carcinoma Diseases 0.000 claims 1
- 238000009093 first-line therapy Methods 0.000 claims 1
- 201000005202 lung cancer Diseases 0.000 claims 1
- 208000020816 lung neoplasm Diseases 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 238000009094 second-line therapy Methods 0.000 claims 1
- 238000009095 third-line therapy Methods 0.000 claims 1
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Claims (45)
1. Способ лечения пациента, больного раком, включающий введение указанному пациенту, нуждающемуся в этом
(a) иммуноконъюгата, который связывается с рецептором фолиевой кислоты 1 (FOLR1), причем указанный иммуноконъюгат содержит (i) антитело или его антигенсвязывающий фрагмент, содержащий последовательность SEQ ID NO: 9 определяющей комплементарность области (CDR)1 вариабельной области тяжелой цепи (VH), последовательность SEQ ID NO: 10 CDR2 VH и последовательность SEQ ID NO: 12 CDR3 VH, и последовательность SEQ ID NO:6 CDR1 вариабельной области легкой цепи (VL), последовательность SEQ ID NO: 7 CDR2 VL, последовательность SEQ ID NO: 8 CDR3 VL, и (ii) майтанзиноид, причем указанный майтанзиноид связан с антителом или его антигенсвязывающим фрагментом посредством сульфо- SPDB, и
(b) анти-ФРЭС агент, агент на основе платины или доксорубицин.
2. Способ по п. 1, отличающийся тем, что иммуноконъюгат вводят в комбинации с анти-ФРЭС агентом.
3. Способ по п. 1, отличающийся тем, что иммуноконъюгат вводят в комбинации с агентом на основе платины.
4. Способ по п. 1, отличающийся тем, что иммуноконъюгат вводят в комбинации с доксорубицином.
5. Способ лечения пациента, больного раком, включающий введение указанному пациенту, нуждающемуся в этом
(а) иммуноконъюгата, который связывается с рецептором фолиевой кислоты 1 (FOLR1), причем указанный иммуноконъюгат содержит (i) антитело или его антигенсвязывающий фрагмент, содержащий последовательность SEQ ID NO: 9 определяющей комплементарность области (CDR)1 вариабельной области тяжелой цепи (VH), последовательность SEQ ID NO: 10 CDR2 VH и последовательность SEQ ID NO: 12 CDR3 VH, и последовательность SEQ ID NO: 6 CDR1 вариабельной области легкой цепи (VL), последовательность SEQ ID NO: 7 CDR2 VL, последовательность SEQ ID NO: 8 CDR3 VL, и (ii) майтанзиноид, причем указанный майтанзиноид связан с антителом или его антигенсвязывающий фрагментом посредством сульфо- SPDB,
(b) (i) анти-ФРЭС агент и агент на основе платины;
(ii) анти-ФРЭС агент и доксорубицин; или
(iii) агент на основе платины и доксорубицин; причем иммуноконъюгат линкер, причем линкер представляет собой сульфо-SPDB.
6. Способ по любому из пп. 1, 2 и 5, отличающийся тем, что анти-ФРЭС агент представляет собой бевацизумаб.
7. Способ по любому из пп. 1, 3, 5 и 6, отличающийся тем, что агент на основе платины представляет собой карбоплатин.
8. Способ по любому из пп. 1, 4 или 5, отличающийся тем, что доксорубицин представляет собой пегилированный липосомальный доксорубицин (PLD).
9. Способ по любому из пп. 1-8, отличающийся тем, что иммуноконъюгат, который связывается с FOLR1, содержит антитело или его антигенсвязывающий фрагмент, который содержит VH, содержащую последовательность SEQ ID NO: 3, и VL, содержащую последовательность SEQ ID NO: 5.
10. Способ по любому из пп. 1-9, отличающийся тем, что иммуноконъюгат содержит антитело, содержащее (i) тяжелую цепь, содержащую аминокислотную последовательность SEQ ID NO: 13, и (ii) а легкую цепь, содержащую аминокислотную последовательность SEQ ID NO: 15, и при этом майтанзиноид представляет собой DM4.
11. Способ по любому из пп. 1-10, отличающийся тем, что иммуноконъюгат содержит антитело, содержащее (i) тяжелую цепь, содержащую аминокислотную последовательность, идентичную аминокислотной последовательности тяжелой цепи, кодируемой плазмидой, депонированной Американской коллекции типовых культур (АТСС) под номером РТА-10772, и (ii) легкая цепь содержит аминокислотную последовательность, идентичную аминокислотной последовательности легкой цепи, кодируемой плазмидой, депонированной Американской коллекции типовых культур (АТСС) под номером РТА-10774, и при этом майтанзиноид представляет собой DM4.
12. Способ по любому из пп. 1-10, отличающийся тем, что майтанзиноид представляет собой DM4.
13. Способ по любому из пп. 1-12, отличающийся тем, что иммуноконъюгат вводят один раз каждые три недели в дозе 6 мг/кг скорректированного идеального веса тела (AIBW).
14. Способ по любому из пп. 1-12, отличающийся тем, что иммуноконъюгат вводят один раз каждые четыре недели в дозе 5 мг/кг скорректированного идеального веса тела (AIBW) или один раз каждые четыре недели в дозе 6 мг/кг скорректированного идеального веса тела (AIBW).
15. Способ по любому из пп. 6, 7 или 9-13, отличающийся тем, что бевацизумаб вводят один раз каждые три недели в дозе 15 мг/кг.
16. Способ по любому из пп. 6, 7 или 9-13, отличающийся тем, что бевацизумаб вводят два раза каждые четыре недели в дозе 10 мг/кг.
17. Способ по любому из пп. 7 или 9-13, отличающийся тем, что карбоплатин вводят один раз каждые три недели в дозе, дающей площадь под кривой (AUC) 5 мг/мл⋅мин или 6 мг/мл⋅мин.
18. Способ по любому из пп. 8-14, отличающийся тем, что PLD вводят один раз каждые четыре недели в дозе 40 мг/м2 или один раз каждые четыре недели в дозе 30 мг/м2.
19. Способ по любому из пп. 1-18, отличающийся тем, что иммуноконъюгат содержит от примерно 1 майтанзиноида на антитело до примерно 8 майтанзионидов на антитело, при этом необязательно иммуноконъюгат содержит от примерно 3 майтанзионидов на антитело до примерно 4 майтанзионидов на антитело.
20. Способ по любому из пп. 1-19, который дополнительно включает введение пациенту стероида, причем стероид вводят в глазной капле.
21. Способ по любому из пп. 1-20, отличающийся тем, что рак представляет собой рак яичников, перитонеальный рак, рак фаллопиевых труб, рак эндометрия или рак легких.
22. Способ по п. 21, отличающийся тем, что рак представляет собой рак яичников, перитонеальный рак или рак эндометрия, причем необязательно рак яичников является устойчивым к препаратам платины.
23. Способ по любому из пп. 1-22, отличающийся тем, что рак экспрессирует FOLR1.
24. Способ по п.23, отличающийся тем, что экспрессию FOLR1 измеряют с помощью иммуногистохимии (ИГХ).
25. Способ по п. 24, отличающийся тем, что по меньшей мере 50% клеток в образце, полученном от пациента, имеют иммуногистохимический показатель (ИГХ) равный по меньшей мере 2.
26. Способ по п. 24, отличающийся тем, что по меньшей мере 75% клеток в образце, полученном от пациента, имеют иммуногистохимический показатель (ИГХ) равный по меньшей мере 2.
27. Способ по п. 24, отличающийся тем, что по меньшей мере 50% клеток в образце, полученном от пациента, имеют иммуногистохимический показатель (ИГХ) равный по меньшей мере 3.
28. Способ по п. 24, отличающийся тем, что по меньшей мере 75% клеток в образце, полученном от пациента, имеют иммуногистохимический показатель (ИГХ) равный по меньшей мере 3.
29. Способ по любому из пп. 1-28, отличающийся тем, что иммуноконъюгат и анти-ФРЭС агент, агент на основе платины, доксорубицин, или их комбинации вводят в отдельных фармацевтических композициях.
30. Способ по любому из пп. 1-29, отличающийся тем, что рак ранее лечили бевацизумабом.
31. Способ по любому из пп. 1-29, отличающийся тем, что рак ранее не лечили бевацизумабом.
32. Способ по любому из пп. 1-31, отличающийся тем, что рак является первично невосприимчивым к лечению препаратами платины.
33. Способ по любому из пп. 1-31, отличающийся тем, что рак устойчив к препаратам платины.
34. Способ по любому из пп. 1-31, отличающийся тем, что рак является чувствительным к препаратам платины.
35. Способ по любому из пп. 1-12 или 31-34, отличающийся тем, что что введение представляет собой терапию первой линии.
36. Способ по любому из пп. 1-34, отличающийся тем, что введение представляет собой терапию второй линии.
37. Способ по любому из пп. 1-34, отличающийся тем, что введение представляет собой терапию третьей линии.
38. Способ по любому из пп. 1-34, отличающийся тем, что введение представляет собой терапию четвертой линии.
39. Способ по любому из пп. 1-34, отличающийся тем, что введение представляет собой терапию пятой линии.
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CN108601828A (zh) | 2018-09-28 |
AU2016323968B2 (en) | 2023-07-06 |
IL298438A (en) | 2023-01-01 |
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CA2994888A1 (en) | 2017-03-23 |
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US20200397806A1 (en) | 2020-12-24 |
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US20190167704A1 (en) | 2019-06-06 |
IL257531B2 (en) | 2023-04-01 |
AU2016323968A1 (en) | 2018-03-01 |
HK1255141A1 (zh) | 2019-08-09 |
CN116440279A (zh) | 2023-07-18 |
JP2018527383A (ja) | 2018-09-20 |
CN108601828B (zh) | 2023-04-28 |
US10172875B2 (en) | 2019-01-08 |
RU2749865C2 (ru) | 2021-06-17 |
KR20180053319A (ko) | 2018-05-21 |
US20170095571A1 (en) | 2017-04-06 |
EP3349796A1 (en) | 2018-07-25 |
IL257531B (en) | 2022-12-01 |
RU2018111205A3 (ru) | 2019-10-17 |
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