RU2019126562A - ЛЕЧЕНИЕ ТРИЖДЫ НЕГАТИВНОГО РАКА МОЛОЧНОЙ ЖЕЛЕЗЫ, ХАРАКТЕРИЗУЮЩЕГОСЯ ЭКСПРЕССИЕЙ Trop-2, С ПОМОЩЬЮ САЦИТУЗУМАБА ГОВИТЕКАНА И ИНГИБИТОРА Rad51 - Google Patents

ЛЕЧЕНИЕ ТРИЖДЫ НЕГАТИВНОГО РАКА МОЛОЧНОЙ ЖЕЛЕЗЫ, ХАРАКТЕРИЗУЮЩЕГОСЯ ЭКСПРЕССИЕЙ Trop-2, С ПОМОЩЬЮ САЦИТУЗУМАБА ГОВИТЕКАНА И ИНГИБИТОРА Rad51 Download PDF

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RU2019126562A
RU2019126562A RU2019126562A RU2019126562A RU2019126562A RU 2019126562 A RU2019126562 A RU 2019126562A RU 2019126562 A RU2019126562 A RU 2019126562A RU 2019126562 A RU2019126562 A RU 2019126562A RU 2019126562 A RU2019126562 A RU 2019126562A
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cancer
antibody
weeks
therapy
seq
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RU2019126562A
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RU2758234C2 (ru
RU2019126562A3 (ru
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Томас М. КАРДИЛЛО
Девид М. ГОЛДЕНБЕРГ
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Иммьюномедикс, Инк.
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Claims (33)

1. Способ лечения рака, характеризующегося экспрессией Trop-2, включающий
а) введение субъекту с раком, характеризующимся экспрессией Trop-2, конъюгата анти-Trop-2 антитело-лекарственное средство (КАС), и
б) введение субъекту ингибитора Rad51.
2. Способ по п. 1, где лекарственное средство, конъюгированное с антителом, индуцирует разрывы цепи ДНК.
3. Способ по п. 2, где лекарственное средство представляет собой ауристатин, таксан, калихеамицин, эпотилон, камптотецин или антрациклин.
4. Способ по п. 3, где лекарственное средство выбрано из группы, состоящей из SN-38, топотекана, доксорубицина, эпирубицина, морфолинодоксорубицина (морфолино-DOX), цианоморфолино-доксорубицина (цианоморфолино-DOX), 2-пирролинодоксорубицина (2-PDOX), пролекарственной формы 2-PDOX (про-2-PDOX), этопозида, цисплатина, оксалиплатина, карбоплатина, баккатина III, паклитаксела и монометилауристатина E (MMAE).
5. Способ по п. 1, где ингибитор Rad51 представляет собой B02 ((E)-3-бензил-2(2-(пиридин-3-ил)винил)хиназолин-4(3H)-он), RI-1 (3-хлор-1-(3,4-дихлорфенил)-4-(4-морфолинил)-1H-пиррол-2,5-дион), DIDS (4,4'-диизотиоцианостилбен-2,2'-дисульфокислота), галенахинон или иматиниб.
6. Способ по п. 1, где субъект представляет собой человека.
7. Способ по п. 1, где КАС вводят в дозировке от 4 мг/кг до 16 мг/кг.
8. Способ по п. 7, где дозировка выбрана из группы, состоящей из 4 мг/кг, 6 мг/кг, 7 мг/кг, 8 мг/кг, 9 мг/кг, 10 мг/кг, 12 мг/кг и 16 мг/кг.
9. Способ по п. 7, где дозировка составляет от 8 мг/кг до 10 мг/кг.
10. Способ по п. 1, где антитело представляет собой гуманизированное антитело RS7, содержащее последовательности CDR легкой цепи CDR1 (KASQDVSIAVA, SEQ ID NO: 1), CDR2 (SASYRYT, SEQ ID NO: 2), и CDR3 (QQHYITPLT, SEQ ID NO: 3) и последовательности CDR тяжелой цепи CDR1 (NYGMN, SEQ ID NO: 4), CDR2 (WINTYTGEPTYTDDFKG, SEQ ID NO: 5) и CDR3 (GGFGSSYWYFDV, SEQ ID NO: 6).
11. Способ по п. 1, где лечение приводит к уменьшению размера опухоли по меньшей мере на 15 %, по меньшей мере на 20 %, по меньшей мере на 30 % или по меньшей мере на 40 %.
12. Способ по п. 1, где рак является метастатическим.
13. Способ по п. 12, дополнительно включающий уменьшение размера или устранение метастазов.
14. Способ по п. 1, где рак является устойчивым к другим способам лечения, но отвечает на комбинированную терапию КАС и ингибитора Rad51.
15. Способ по п. 1, где лекарственное средство представляет собой SN-38.
16. Способ по п. 15, где между SN-38 и антителом присутствует линкер CL2A, и структура КАС представляет собой MAb-CL2A-SN-38
Figure 00000001
17. Способ по п. 15, где к каждой молекуле антитела присоединено 6 или более молекул SN-38.
18. Способ по п. 15, где к каждой молекуле антитела присоединено от 6 до 8 молекул SN-38.
19. Способ по п. 15, где к каждой молекуле антитела присоединено от 7 до 8 молекул SN-38.
20. Способ по п. 1, где антитело представляет собой антитело IgG1 или IgG4.
21. Способ по п. 1, где антитело имеет аллотип, выбранный из группы, состоящей из аллотипов G1m3, G1m3,1, G1m3,2, G1m3,1,2, nG1m1, nG1m1,2 и Km3.
22. Способ по п. 7, где дозировку КАС вводят человеку один или два раза в неделю по схеме с курсом, выбранным из группы, состоящей из: (i) еженедельно, (ii) раз в две недели, (iii) одна неделя терапии, за которой следуют две, три или четыре недели отдыха, (iv) две недели терапии, за которыми следуют одна, две, три или четыре недели отдыха, (v) три недели терапии, за которыми следуют одна, две, три, четыре или пять недель отдыха, (vi) четыре недели терапии, за которыми следуют одна, две, три, четыре или пять недель отдыха, (vii) пять недель терапии, за которыми следуют одна, две, три, четыре или пять недель отдыха, и (viii) ежемесячно.
23. Способ по п. 22, где курс повторяют 4, 6, 8, 10, 12, 16 или 20 раз.
24. Способ по п. 15, где пациент ранее перенес рецидив или был устойчив к лечению топотеканом или иринотеканом.
25. Способ по п. 1, дополнительно включающий c) введение одного или более терапевтических средств, выбранных из группы, состоящей из неконъюгированного антитела, иммуноконъюгата, генной терапии, химиотерапии, терапевтического пептида, цитокиновой терапии, локализованной лучевой терапии, хирургии, терапии на основе РНК-интерференции, лекарственного средства, токсина и цитокина.
26. Способ по п. 25, где лекарственное средство, токсин или химиотерапевтический агент выбраны из группы, состоящей из 5-фторурацила, афатиниба, аплидина, азарибина, анастрозола, антрациклинов, акситиниба, AVL-101, AVL-291, бендамустина, блеомицина, бортезомиба, бозутиниба, бриостатина-1, бусульфана, калихеамицина, камптотецина, карбоплатина, 10-гидроксикамптотецина, кармустина, целебрекса, хлорамбуцила, цисплатина (CDDP), ингибиторов Cox-2, иринотекана (СРТ-11), SN-38, карбоплатина, кладрибина, камптотеканов, циклофосфамида, кризотиниба, цитарабина, дакарбазина, дазатиниба, динациклиба, доцетаксела, дактиномицина, даунорубицина, доксорубицина, 2-пирролинодоксорубицина (2P-DOX), циано-морфолино доксорубицина, доксорубицин глюкуронида, эпирубицин глюкуронида, эрлотиниба, эстрамустин, эпидофиллотоксина, эрлотиниба, энтиностата, агентов, связывающих рецепторы эстрогена, этопозида (VP16), этопозид глюкуронида, этопозид фосфата, экземестана, финголимода, флавопиридола, флоксуридина (FUdR), 3',5'-О-диолеоил-FudR (FUdR-dO), флударабина, флутамида, ингибиторов фарнезил-протеинтрансферазы, фостаматиниба, ганетеспиба, GDC-0834, GS-1101, гефитиниба, гемцитабина, гидроксимочевины, ибрутиниба, идарубицина, иделалисиба, ифосфамида, иматиниба, L-аспарагиназы, лапатиниба, ленолидамида, лейковорина, LFM-А13, ломустина, мехлоретамина, мелфалана, меркаптопурина, 6-меркаптопурина, метотрексата, митоксантрона, митрамицина, митомицина, митотана, навелбина, нератиниба, нилотиниба, нитрозомочевины, олапариба, пликомицина, прокарбазина, паклитаксела, PCI-32765, пентостатина, PSI-341, ралоксифена, семустина, сорафениба, стрептозоцина, SU11248, сунитиниба, тамоксифена, темазоломида (водная форма дакарбазина (DTIC)), трансплатина, талидомида, тиогуанина, тиотепы, тенипозида, топотекана, урацилового иприта, ваталаниба, винорелбина, винбластина, винкристина, алкалоидов барвинка и ZD1839.
27. Способ по п. 25, где лекарственное средство представляет собой цисплатин или карбоплатин.
28. Способ по п. 1, где КАС представляет собой сацитузумаб говитекан.
29. Способ по п. 1, где рак представляет собой трижды негативный рак молочной железы (ТНРМЖ), мелкоклеточный рак легкого (МКРЛ), немелкоклеточный рак легкого (НМРЛ), уротелиальный рак, рак желудка, рак поджелудочной железы, колоректальный рак, рак предстательной железы, рак яичников, рак почки или рак мочевого пузыря.
30. Способ по п. 1, где рак представляет собой ТНРМЖ.
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