JP6724136B2 - がん治療のためのBcl−2阻害剤及びMEK阻害剤の組み合わせ - Google Patents
がん治療のためのBcl−2阻害剤及びMEK阻害剤の組み合わせ Download PDFInfo
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- JP6724136B2 JP6724136B2 JP2018522692A JP2018522692A JP6724136B2 JP 6724136 B2 JP6724136 B2 JP 6724136B2 JP 2018522692 A JP2018522692 A JP 2018522692A JP 2018522692 A JP2018522692 A JP 2018522692A JP 6724136 B2 JP6724136 B2 JP 6724136B2
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Description
本願は、2015年11月3日に出願された米国特許仮出願第62/250231号の優先権を主張し、その内容は、あたかもその全体が記載されているように出典明示により本明細書に援用される。本願は、2015年12月4日に出願された米国特許仮出願第62/263082号の優先権を主張し、その内容は、あたかもその全体が記載されているように出典明示により本明細書に援用される。
酵素のSrcサブファミリーは、がん遺伝子に結びついている。(非受容体型チロシンキナーゼのより詳細な検討については、Bolen、Oncogene、8:2025-2031(1993)を参照のこと、当該文献は出典明示により本明細書に援用される。)
ベネトクラクスは以下の構造を有する。
用語「哺乳動物」として、限定されないが、ヒト、マウス、ラット、モルモット、サル、イヌ、ネコ、ウマ、ウシ、ブタ、ヒツジ、家禽が挙げられる。用語「患者」は、哺乳動物を指し、一実施態様において、患者はヒト男性又はヒト女性である。
本発明の併用療法は、選択的Bcl−2阻害剤の投与を伴う。選択的Bcl−2阻害剤を使用する治療方法は、米国特許出願第2012/0129853号に開示され、その開示は、あたかもその全体が記載されているように出典明示により本明細書に援用される。このことに関して、選択的Bcl−2阻害剤は、Bcl−2ファミリーの中の特定のタンパク質に選択的に結合する。いくつかの実施態様において、本発明の併用療法は、Bcl−2タンパク質を選択的に阻害する選択的Bcl−2阻害剤の投与を伴う。例えば、4−(4−{[2−(4−クロロフェニル)−4,4−ジメチルシクロヘキサ−1−エン−1−イル]メチル}ピペラジン−1−イル)−N−({3−ニトロ−4−[(テトラヒドロ−2H−ピラン−4−イルメチル)アミノ]フェニル}スルホニル)−2−(1H−ピロロ[2,3−b]ピリジン−5−イルオキシ)ベンズアミド(ベネトクラクス、又はABT−199/GDC−0199としても知られ、任意選択的に呼ばれる)は、経口投与が可能であり、アポトーシスを制御する制御因子タンパク質のBcl−2ファミリーの一員である、Bcl−2の強力で高度な選択的阻害剤である。ABT−199は、Bcl−xLに結合し、Bcl−xLに対する応答を誘発するのに必要とされる阻害剤より、非常に低い濃度で、Bcl−2タンパク質に選択的に結合し、Bcl−2タンパク質に対する応答を誘発する。このようにABT−199が患者に投与されると、阻害剤が、Bcl−xLよりBcl−2を阻害する傾向が強くなる。ABT−199は、Bcl−xLに対する結合親和性より少なくとも約500、少なくとも約1000、少なくとも約2000、少なくとも約2500、少なくとも約3000、少なくとも約3500、及び少なくとも約4000倍少ないBcl−2に対する競合的結合親和性(Ki)を有する傾向がある。このように、濃度が低くとも(すなわち、ピコモル濃度)、ABT−199は、Bcl−2タンパク質に結合し、阻害する。
コビメチニブ(GDC−0973としても知られ、本明細書において任意選択的に呼ばれる)は、経口投与が可能であり、MEK1及びMEK2の強力で高度な選択的阻害剤である。MEK1及びMEK2は、RAS/RAF経路の中心的な成分である。コビメチニブを含む選択的MEK阻害剤は、米国特許第7803839号に開示され、その開示は、あたかもその全体が記載されているように出典明示により本明細書に援用される。
典型的には、薬学的製剤中の薬物又は薬物の組み合わせの濃度は、親化合物の等量の少なくとも約1重量%、例えば約1重量%−約50重量%であるが、より低い、高い濃度も特定の場合においては許容可能又は達成可能である。例示的に、様々な実施態様における薬物の濃度は、親化合物の等量の少なくとも約2重量%、例えば約2重量%−50重量%、又は少なくとも約5重量%、例えば、約5重量%−約40重量%、例えば、約5重量%、約10重量%、約15重量%、約20重量%、約25重量%、約30重量%、約35重量%、又は約40重量%である。いくつかの実施態様において、薬物の濃度は、約5%−約15%、例えば、約5%−約12%、例えば約5%、約6%、約7%、約8%、約9%、約10%、約11%、又は約12%であってもよい。
いくつかの実施態様において、本発明の方法は、治療を必要とする哺乳動物、例えば、ヒト患者に、一又は複数の抗アポトーシス性Bcl−2タンパク質、抗アポトーシス性Bcl−XLタンパク質、及び抗アポトーシス性Bcl−wタンパク質を過剰発現している最中に治療的有効量の4−(4−{[2−(4−クロロフェニル)−4,4−ジメチルシクロヘキサ−1−エン−1−イル]メチル}ピペラジン−1−イル)−N−({3−ニトロ−4−[(テトラヒドロ−2H−ピラン−4−イルメチル)アミノ]フェニル}スルホニル)−2−(1H−ピロロ[2,3−b]ピリジン−5−イルオキシ)ベンズアミド(ベネトクラクス又はABT−199/GDC−0199)又はその薬学的に許容される塩、及び治療的有効量の[3,4−ジフルオロ−2−(2−フルオロ−4−ヨードアニリノ)フェニル]{3−ヒドロキシ−3−[(2S)−ピペリジン−2−イル]アゼチジン−1−イル}メタノン(コビメチニブ又はGDC−0973)又はその薬学的に許容される塩を投与して疾患を治療することを伴う。
用語「経口送達可能な」、「経口投与」、及び「経口投与される」は、本明細書において、対象に経口投与(p.o.)、すなわち、例えば適切な量の水又はその他の飲料に適した液体を用いて、組成物をすぐに飲み込む投与を指す。「経口投与」は、本明細書では、例えば、舌下若しくは頬側投与、又は歯周組織等の口腔内組織に局所投与する、組成物をすぐに飲み込むことを伴わない口腔内投与と区別する。
本発明の併用療法は、その他の化学療法薬と又は電離放射線と使用するのに適しうる。併用療法は、例示的に、一又は複数のボルテゾミブ、カルボプラチン、シスプラチン、シクロホスファミド、ダカルバジン、デキサメタゾン、ドセタキセル、ドキソルビシン、エトポシド、フルダラビン、イリノテカン、パクリタキセル、ラパマイシン、リツキシマブ、ビンクリスチン等、例えば、CHOP(シクロホスファミド+ドキソルビシン+ビンクリスチン+プレドニゾン)、RCVP(リツキシマブ+シクロホスファミド+ビンクリスチン+プレドニゾン)、R−CHOP(リツキシマブ+CHOP)又はDA−EPOCH−R(用量を調節したエトポシド、プレドニゾン、ビンクリスチン、シクロホスファミド、ドキソルビシン及びリツキシマブ)等の多剤療法と同時に、本発明の併用療法を投与することを含む。
Claims (19)
- 治療を必要とする哺乳動物における異常細胞増殖に関連する増殖性疾患を治療するための、治療的有効量のMEK阻害剤及び選択的Bcl−2阻害剤の組み合わせを含む医薬であって、
MEK阻害剤が[3,4−ジフルオロ−2−(2−フルオロ−4−ヨードアニリノ)フェニル]{3−ヒドロキシ−3−[(2S)−ピペリジン−2−イル]アゼチジン−1−イル}メタノン(コビメチニブ)又はその薬学的に許容される塩を含み、
選択的Bcl−2阻害剤が4−(4−{[2−(4−クロロフェニル)−4,4−ジメチルシクロヘキサ−1−エン−1−イル]メチル}ピペラジン−1−イル)−N−({3−ニトロ−4−[(テトラヒドロ−2H−ピラン−4−イルメチル)アミノ]フェニル}スルホニル)−2−(1H−ピロロ[2,3−b]ピリジン−5−イルオキシ)ベンズアミド(ABT−199)又はその薬学的に許容される塩を含む、医薬。 - 増殖性疾患ががんである、請求項1に記載の医薬。
- 増殖性疾患がABT−199耐性増殖性疾患である、請求項1に記載の医薬。
- 増殖性疾患が、中皮腫、膀胱がん、膵臓がん、皮膚がん、頭頸部がん、皮膚又は眼内黒色腫、卵巣がん、乳がん、子宮がん、卵管癌、子宮内膜癌、子宮頸癌、膣癌、外陰癌、骨がん、結腸がん、直腸がん、肛門がん、胃がん、胃腸がん、慢性リンパ球性白血病、急性リンパ球性白血病、食道がん、小腸がん、内分泌系のがん、甲状腺がん、副甲状腺がん、副腎がん、軟部肉腫、尿道がん、陰茎がん、精巣がん、肝細胞がん、原発性又は続発性中枢神経系腫瘍、原発又は続発性脳腫瘍、ホジキン病、慢性又は急性白血病、急性骨髄性白血病、慢性骨髄性白血病、リンパ球性リンパ腫、リンパ芽球性白血病、濾胞性リンパ腫、T細胞又はB細胞起源リンパ系悪性腫瘍、メラノーマ、多発性骨髄腫、口腔がん、非小細胞肺がん、前立腺がん、小細胞肺がん、腎臓及び/又は尿管がん、腎細胞癌、腎盂癌、中枢神経系腫瘍、中枢神経系原発リンパ腫、非ホジキンリンパ腫、脊椎腫瘍、脳幹神経膠腫、下垂体腺腫、副腎皮質がん、胆嚢がん、脾臓がん、胆管細胞癌、線維肉腫、神経芽細胞腫、網膜芽細胞腫並びにその組み合わせから成る群から選択される、請求項1に記載の医薬。
- 増殖性疾患が急性骨髄性白血病である、請求項1に記載の医薬。
- 増殖性疾患がABT−199耐性急性骨髄性白血病である、請求項5に記載の医薬。
- 増殖性疾患が多発性骨髄腫である、請求項1に記載の医薬。
- 哺乳動物がヒトである、請求項1から7の何れか一項に記載の医薬。
- MEK阻害剤が選択的Bcl−2阻害剤と同時に投与される、請求項1から8の何れか一項に記載の医薬。
- MEK阻害剤及び選択的Bcl−2阻害剤が一緒に製剤化される、請求項1から9の何れか一項に記載の医薬。
- MEK阻害剤及び選択的Bcl−2阻害剤が、薬学的に許容される賦形剤をさらに含む薬学的組成物において一緒に製剤化される、請求項10に記載の医薬。
- MEK阻害剤が選択的Bcl−2阻害剤と連続的に投与される、請求項1から8の何れか一項に記載の医薬。
- MEK阻害剤及び選択的Bcl−2阻害剤が、別個の経口利用可能な剤形に製剤化される、請求項12に記載の医薬。
- 急性骨髄性白血病の治療における使用のための医薬品であって、(i)[3,4−ジフルオロ−2−(2−フルオロ−4−ヨードアニリノ)フェニル]{3−ヒドロキシ−3−[(2S)−ピペリジン−2−イル]アゼチジン−1−イル}メタノン(コビメチニブ)又はその薬学的に許容される塩を含む第1の組成物、及び(ii)4−(4−{[2−(4−クロロフェニル)−4,4−ジメチルシクロヘキサ−1−エン−1−イル]メチル}ピペラジン−1−イル)−N−({3−ニトロ−4−[(テトラヒドロ−2H−ピラン−4−イルメチル)アミノ]フェニル}スルホニル)−2−(1H−ピロロ[2,3−b]ピリジン−5−イルオキシ)ベンズアミド(ABT−199)又はその薬学的に許容される塩を含む第2の組成物を含む、医薬品。
- 第1の組成物が薬学的に許容される賦形剤をさらに含む、請求項14に記載の医薬品。
- 第2の組成物が薬学的に許容される賦形剤をさらに含む、請求項14又は15に記載の医薬品。
- 急性骨髄性白血病の治療における使用のための医薬品であって、単一の経口投与剤形中に、(i)[3,4−ジフルオロ−2−(2−フルオロ−4−ヨードアニリノ)フェニル]{3−ヒドロキシ−3−[(2S)−ピペリジン−2−イル]アゼチジン−1−イル}メタノン(コビメチニブ)又はその薬学的に許容される塩、及び(ii)4−(4−{[2−(4−クロロフェニル)−4,4−ジメチルシクロヘキサ−1−エン−1−イル]メチル}ピペラジン−1−イル)−N−({3−ニトロ−4−[(テトラヒドロ−2H−ピラン−4−イルメチル)アミノ]フェニル}スルホニル)−2−(1H−ピロロ[2,3−b]ピリジン−5−イルオキシ)ベンズアミド(ABT−199)又はその薬学的に許容される塩を含む、医薬品。
- ABT−199耐性急性骨髄性白血病の治療における使用のための、請求項14に記載の医薬品。
- ABT−199耐性急性骨髄性白血病の治療における使用のための、請求項17に記載の医薬品。
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US9539251B2 (en) * | 2012-09-07 | 2017-01-10 | Genentech, Inc. | Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor |
GB201809746D0 (en) * | 2018-06-14 | 2018-08-01 | Berlin Chemie Ag | Pharmaceutical combinations |
TW202023568A (zh) * | 2018-07-30 | 2020-07-01 | 瑞典商阿斯特捷利康公司 | 用於治療癌症之組合療法 |
KR20210094532A (ko) | 2018-10-16 | 2021-07-29 | 더 존스 홉킨스 유니버시티 | 혈관형 엘러스 단로스 증후군 및 연관 장애를 치료하기 위한 조성물 및 방법 |
WO2020181219A1 (en) * | 2019-03-06 | 2020-09-10 | The Regents Of The University Of Colorado, A Body Corporate | Methods of detecting and treating venetoclax-resistant acute myeloid leukemia |
MA55816A (fr) * | 2019-04-29 | 2022-03-16 | Immunogen Inc | Combinaisons thérapeutiques comprenant des immunoconjugués anti-cd123 |
EP3976200A4 (en) * | 2019-06-03 | 2023-07-05 | Sanford Burnham Prebys Medical Discovery Institute | USE OF SYNTHETIC LETHAL PARTNERS TO TREAT CANCER |
CN113727719A (zh) * | 2020-07-17 | 2021-11-30 | 德尔塔菲制药股份有限公司 | 血癌的新型治疗方法及新型治疗剂 |
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NZ567140A (en) | 2005-10-07 | 2011-09-30 | Exelixis Inc | Azetidines as MEK inhibitors for the treatment of proliferative diseases |
MX2010012064A (es) * | 2008-05-05 | 2010-12-06 | Schering Corp | Uso secuencial de agentes quimioterapeuticos citotoxicos para el tratamiento de cancer. |
US20100009934A1 (en) * | 2008-06-09 | 2010-01-14 | Combinatorx, Incorporated | Beta adrenergic receptor agonists for the treatment of b-cell proliferative disorders |
US8546399B2 (en) | 2009-05-26 | 2013-10-01 | Abbvie Inc. | Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases |
KR102095698B1 (ko) | 2010-10-29 | 2020-04-01 | 애브비 인코포레이티드 | 아폽토시스―유도제를 포함하는 고체 분산체 |
UA113500C2 (xx) | 2010-10-29 | 2017-02-10 | Одержані екструзією розплаву тверді дисперсії, що містять індукуючий апоптоз засіб | |
ES2603129T3 (es) | 2010-11-23 | 2017-02-23 | Abbvie Ireland Unlimited Company | Métodos de tratamiento utilizando inhibidores selectivos de Bcl-2 |
DK2643322T3 (en) | 2010-11-23 | 2017-12-11 | Abbvie Inc | SALTS AND CRYSTAL FORMS OF AN APOPTOSIS-INducing Agent |
BR112014004587A2 (pt) * | 2011-08-31 | 2017-03-14 | Novartis Ag | combinações sinérgicas de inibidores de pi3k- e de mek |
PT2884979T (pt) | 2012-08-17 | 2019-09-04 | Hoffmann La Roche | Terapêuticas combinadas para o melanoma, compreendendo a administração de cobimetinib e vemurafinib |
US9539251B2 (en) | 2012-09-07 | 2017-01-10 | Genentech, Inc. | Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor |
US10111897B2 (en) * | 2013-10-03 | 2018-10-30 | Duke University | Compositions and methods for treating cancer with JAK2 activity |
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US20210169865A1 (en) | 2021-06-10 |
MA43170A (fr) | 2018-09-12 |
IL258741A (en) | 2018-06-28 |
BR112018008882A8 (pt) | 2019-02-26 |
CA3001880C (en) | 2021-08-17 |
AU2016349279A1 (en) | 2018-05-10 |
HK1259545A1 (zh) | 2019-11-29 |
BR112018008882A2 (pt) | 2018-11-06 |
EP3370775B1 (en) | 2023-04-19 |
US20180303815A1 (en) | 2018-10-25 |
KR20180054852A (ko) | 2018-05-24 |
US10959993B2 (en) | 2021-03-30 |
CN108601839A (zh) | 2018-09-28 |
CN108601839B (zh) | 2021-10-26 |
KR102124715B1 (ko) | 2020-06-18 |
JP2018534298A (ja) | 2018-11-22 |
MX2018005233A (es) | 2019-04-29 |
WO2017079399A1 (en) | 2017-05-11 |
EP3370775A1 (en) | 2018-09-12 |
IL258741B (en) | 2021-08-31 |
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