JP5932217B2 - Gitr結合分子を使用する併用療法 - Google Patents
Gitr結合分子を使用する併用療法 Download PDFInfo
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Description
本発明の好ましい実施形態では、例えば以下が提供される:
(項目1)
被験体において腫瘍細胞の増殖が阻害されるように、GITR結合分子またはその抗原結合フラグメント、および1またはそれより多いサイクルの少なくとも1つの付加的な作用物質を被験体に投与することを含む、被験体において腫瘍細胞の増殖を阻害するための方法。
(項目2)
腫瘍の大きさが縮小されるように、GITR結合分子またはその抗原結合フラグメント、および1またはそれより多いサイクルの少なくとも1つの付加的な作用物質を被験体に投与することを含む、腫瘍を有する被験体において腫瘍の大きさを縮小するための方法。
(項目3)
少なくとも1つの付加的な作用物質をGITR結合分子またはその抗原結合フラグメントの投与の前に被験体に投与する、項目1または2に記載の方法。
(項目4)
少なくとも1つの付加的な作用物質をGITR結合分子またはその抗原結合フラグメントと同時に被験体に投与する、項目1または2に記載の方法。
(項目5)
少なくとも1つの付加的な作用物質をGITR結合分子またはその抗原結合フラグメントの投与後に被験体に投与する、項目1または2に記載の方法。
(項目6)
少なくとも1つの付加的な作用物質が化学療法剤である、項目1または2に記載の方法。
(項目7)
前記化学療法剤が代謝拮抗薬である、項目6に記載の方法。
(項目8)
前記代謝拮抗薬が、アミノプテリン、メトトレキサート、ペメトレキセド、ラルチトレキセド、クラドリビン、クロファラビン、フルダラビン、メルカプトプリン、ペントスタチン、チオグアニン、カペシタビン、シタラビン、フルオロウラシル、フロクスウリジンおよびゲムシタビンから成る群より選択される、項目7に記載の方法。
(項目9)
前記代謝拮抗薬がヌクレオシド類似体である、項目7に記載の方法。
(項目10)
前記ヌクレオシド類似体がゲムシタビンである、項目9に記載の方法。
(項目11)
前記ヌクレオシド類似体がフルオロウラシルである、項目9に記載の方法。
(項目12)
前記化学療法剤が、微小管形成に影響を及ぼす作用物質である、項目6に記載の方法。
(項目13)
前記微小管形成に影響を及ぼす作用物質が、パクリタキセル、ドセタキセル、ビンクリスチン、ビンブラスチン、ビンデシン、ビノレルビン、タキソテール、エトポシドおよびテニポシドから成る群より選択される、項目12に記載の方法。
(項目14)
前記微小管形成に影響を及ぼす作用物質がパクリタキセルである、項目13に記載の方法。
(項目15)
前記化学療法剤がアルキル化剤である、項目6に記載の方法。
(項目16)
前記アルキル化剤がシクロホスファミドである、項目15に記載の方法。
(項目17)
前記化学療法剤が細胞障害性抗生物質である、項目6に記載の方法。
(項目18)
前記細胞障害性抗生物質がトポイソメラーゼII阻害剤である、項目17に記載の方法。
(項目19)
前記トポイソメラーゼII阻害剤がドキソルビシンである、項目18に記載の方法。
(項目20)
前記GITR結合分子がヒト化抗体またはその抗体フラグメントである、項目1または2に記載の方法。
(項目21)
ヒト化抗体が、配列番号1、2または3、4、5、6、または7に示すCDRを含む、項目16に記載の方法。
(項目22)
前記GITR結合分子がキメラ抗体またはその抗体フラグメントである、項目1または2に記載の方法。
(項目23)
前記腫瘍の種類が、膵癌、黒色腫、乳癌、肺癌、気管支癌、結腸直腸癌、前立腺癌、胃癌、卵巣癌、膀胱癌、脳または中枢神経系の癌、末梢神経系の癌、食道癌、子宮頸癌、子宮または子宮内膜癌、口腔または咽頭の癌、肝癌、腎癌、精巣癌、胆道癌、小腸または虫垂癌、唾液腺癌、甲状腺癌、副腎癌、骨肉腫、軟骨肉腫、および血液学的な組織の癌から成る群より選択される、項目1または2に記載の方法。
(項目24)
前記腫瘍が結腸腫瘍である、項目23に記載の方法。
(項目25)
前記結腸腫瘍が腺癌である、項目24に記載の方法。
(項目26)
前記腫瘍が黒色腫である、項目1または2に記載の方法。
(項目27)
前記腫瘍が、結腸腫瘍、肺腫瘍、乳房腫瘍、胃腫瘍、前立腺腫瘍、子宮頸腫瘍、膣腫瘍および膵腫瘍から成る群より選択される、項目1または2に記載の方法。
(項目28)
前記腫瘍が、第I期、第II期、第III期および第IV期から成る群より選択される病期にある、項目1または2に記載の方法。
(項目29)
前記腫瘍が少なくとも約0.5mm×0.5mmである、項目1または2に記載の方法。
(項目30)
前記腫瘍が少なくとも約1mm×1mmである、項目1または2に記載の方法。
(項目31)
前記腫瘍が少なくとも約100mm 3 の体積を有する、項目2に記載の方法。
(項目32)
前記腫瘍が転移性である、項目2に記載の方法。
(項目33)
前記GITR結合分子またはその抗原結合フラグメント、および少なくとも1つの化学療法剤の投与が、約42%を超える腫瘍の大きさの抑制を生じさせる、項目1または2に記載の方法。
(項目34)
腫瘍の大きさが縮小されるように、GITR抗体またはその抗原結合フラグメント、および1またはそれより多いサイクルのゲムシタビンを被験体に投与することを含む、結腸の腺癌を有する被験体において腫瘍の大きさを縮小するための方法。
(項目35)
前記腫瘍が、処置の開始時に樹立腫瘍である、項目34に記載の方法。
(項目36)
腫瘍の大きさが縮小されるように、GITR抗体またはその抗原結合フラグメント、および1またはそれより多いサイクルのパクリタキセルを被験体に投与することを含む、黒色腫を有する被験体において腫瘍の大きさを縮小するための方法。
(項目37)
前記腫瘍が、処置の開始時に樹立腫瘍である、項目36に記載の方法。
(項目38)
腫瘍が、処置の開始時に二次腫瘍である、項目36に記載の方法。
(項目39)
腫瘍の大きさが縮小されるように、GITR抗体またはその抗原結合フラグメント、および1またはそれより多いサイクルのシクロホスファミドを被験体に投与することを含む、結腸の腺癌を有する被験体において腫瘍の大きさを縮小するための方法。
(項目40)
前記腫瘍が、処置の開始時に樹立腫瘍である、項目39に記載の方法。
(項目41)
前記腫瘍が、処置の開始時に二次腫瘍である、項目39に記載の方法。
(項目42)
腫瘍の大きさが縮小されるように、GITR抗体またはその抗原結合フラグメント、および1またはそれより多いサイクルのフルオロウラシルを被験体に投与することを含む、結腸の腺癌を有する被験体において腫瘍の大きさを縮小するための方法。
(項目43)
前記腫瘍が、処置の開始時に樹立腫瘍である、項目42に記載の方法。
(項目44)
腫瘍の大きさが縮小されるように、GITR抗体またはその抗原結合フラグメント、および1またはそれより多いサイクルのドキソルビシンを被験体に投与することを含む、結腸の腺癌を有する被験体において腫瘍の大きさを縮小するための方法。
(項目45)
前記腫瘍が、処置の開始時に樹立腫瘍である、項目44に記載の方法。
(項目46)
GITR結合分子がヒト化抗体またはその抗体フラグメントである、項目34、36、39、42および44のいずれか一項に記載の方法。
(項目47)
前記ヒト化抗体が、配列番号1、2または3、4、5、6、または7に示すCDRを含む、項目46に記載の方法。
(項目48)
GITR結合分子がキメラ抗体またはその抗体フラグメントである、項目34、36、39、42および44のいずれか一項に記載の方法。
(項目49)
a)包装材料、
b)GITR結合分子またはその抗原結合フラグメント、および
c)GITR結合分子またはその抗原結合フラグメントが少なくとも1つの付加的な作用物質と共に投与できることを指示する、包装材料内に含まれるラベルまたは添付文書
を含むキット。
(項目50)
前記少なくとも1つの付加的な作用物質が化学療法剤である、項目49に記載のキット。
(項目51)
前記化学療法剤が代謝拮抗薬である、項目50に記載のキット。
(項目52)
前記代謝拮抗薬がヌクレオシド類似体である、項目51に記載のキット。
(項目53)
前記ヌクレオシド類似体がゲムシタビンである、項目52に記載のキット。
(項目54)
前記ヌクレオシド類似体がフルオロウラシルである、項目52に記載のキット。
(項目55)
前記化学療法剤が、微小管形成に影響を及ぼす作用物質である、項目50に記載のキット。
(項目56)
前記微小管形成に影響を及ぼす作用物質がパクリタキセルである、項目55に記載のキット。
(項目57)
前記化学療法剤がアルキル化剤である、項目50に記載のキット。
(項目58)
前記アルキル化剤がシクロホスファミドである、項目57に記載のキット。
(項目59)
前記化学療法剤が細胞障害性抗生物質である、項目50に記載の方法。
(項目60)
前記細胞障害性抗生物質がトポイソメラーゼII阻害剤である、項目59に記載の方法。
(項目61)
前記トポイソメラーゼII阻害剤がドキソルビシンである、項目60に記載の方法。
(項目62)
前記GITR結合分子がヒト化抗体またはその抗体フラグメントである、項目49に記載のキット。
(項目63)
前記ヒト化抗体が、配列番号1、2または3、4、5、6、または7に示すCDRを含む、項目62に記載のキット。
(項目64)
前記GITR結合分子がキメラ抗体またはその抗体フラグメントである、項目49に記載のキット。
便宜上、本発明のさらなる説明の前に、本明細書、実施例および付属の特許請求の範囲において使用されるいくつかの用語をここで定義する。
本発明の方法における使用のためのGITR結合分子は、たとえば米国特許公報第US20070098719号、同第US20050014224号および国際公開公報第WO05007190号に述べられている結合分子のような、GITRに特異的に結合し、GITRアゴニストとして働く(たとえばエフェクターT細胞応答の上昇および/または体液性免疫の上昇によって明らかにされる)結合分子を包含する。
1つの実施形態では、本発明の併用療法における使用のための付加的な作用物質は化学療法剤である。
1.トポイソメラーゼII阻害剤(細胞障害性抗生物質)、たとえばアントラサイクリン類/アントラセンジオン類、たとえばドキソルビシン、エピルビシン、イダルビシンおよびネモルビシン、アントラキノン類、たとえばミトキサントロンおよびロソキサントロン、ならびにポドフィロトキシン類、たとえばエトポシドおよびテニポシド;
2.微小管形成に影響を及ぼす作用物質(有糸分裂阻害剤)、たとえば植物アルカロイド類(たとえば、生物学的に活性で細胞傷害性である、植物に由来するアルカリ性含窒素分子のファミリーに属する化合物)、たとえばタキサン、たとえばパクリタキセルおよびドセタキセル、ならびにビンカアルカロイド類、たとえばビンブラスチン、ビンクリスチンおよびビノレルビン、ならびにポドフィロトキシンの誘導体;
3.アルキル化剤、たとえばナイトロジェンマスタード、エチレンイミン化合物、アルキルスルホン酸塩類、ならびにニトロソ尿素類、ダカルバジン、シクロホスファミド、イホスファミドおよびメルファランなどのアルキル化作用を有する他の化合物;
4.代謝拮抗薬(ヌクレオシド阻害剤)、たとえば葉酸塩類、たとえば葉酸、フルオロピリミジン類、5−フルオロウラシル、カペシタビン、ゲムシタビン、メトトレキサートおよびエダトレキサートなどのプリンまたはピリミジン類似体;
5.トポイソメラーゼI阻害剤、たとえばトポテカン、イリノテカンおよび9−ニトロカンプトテシン、ならびにカンプトテシン誘導体;および
6.白金化合物/複合体、たとえばシスプラチン、オキサリプラチンおよびカルボプラチン。
1.ホルモン、ホルモン類似体およびホルモン複合体、たとえばエストロゲンおよびエストロゲン類似体、プロゲステロン、プロゲステロン類似体およびプロゲスチン、アンドロゲン、副腎皮質ステロイド、抗エストロゲン、抗アンドロゲン、抗テストステロン、副腎ステロイド阻害剤、および抗黄体形成ホルモン;ならびに
2.インターロイキン、インターフェロン、コロニー刺激因子等のような、酵素、タンパク質、ペプチド、ポリクローナルおよび/またはモノクローナル抗体。
本発明はさらに、本発明の併用療法を被験体に投与する方法を提供する。
本発明は、本発明の方法の使用のためのキットおよび製品を提供する。本発明はまた、癌の処置のために本発明において使用されるGITR結合分子および2番目の作用物質を投与するための包装された医薬組成物またはキットに関する。本発明の1つの実施形態では、キットまたは製品は、GITR結合分子、および少なくとも1つの付加的な作用物質、たとえば化学療法剤と組み合わせて癌の処置のために投与するための指示書を含む。もう1つの実施形態では、キットは、GITR結合分子との併用療法における使用のための少なくとも1つの付加的な作用物質を含有する2番目の容器を含む。指示書は、種々の用量のGITR結合分子および少なくとも1つの化学療法剤を、どのようにして、たとえば静脈内に、およびいつ、たとえば0週目と2週目に、処置のために被験体に投与すべきかを説明し得る。
GITR結合分子とヌクレオシド類似体の組合せは結腸癌の動物モデルにおいて腫瘍量を減少させ、生存時間を延長させる。
GITR結合分子と微小管形成に影響を及ぼす作用物質の組合せは黒色腫の動物モデルにおいて腫瘍量を減少させる。
GITR結合分子とアルキル化剤の組合せは結腸癌の動物モデルにおいて腫瘍量を減少させる。
GITR結合分子とアルキル化剤またはヌクレオシド類似体の組合せで処置した結腸癌の動物モデルは、CT26細胞に対する強固な記憶応答を発現する。
GITR結合分子と代謝拮抗薬の組合せは結腸癌の動物モデルにおいて腫瘍量を減少させる。
GITR結合分子と細胞障害性抗生物質の組合せは結腸癌の動物モデルにおいて腫瘍量を減少させる。
GITR結合分子とアルキル化剤の組合せは黒色腫の動物モデルにおいて腫瘍量を減少させる。
当業者は、本明細書で述べる本発明の特定実施形態に対する多くの等価物を認識する、または常套的な実験だけを使用して確認することができる。そのような等価物は以下の特許請求の範囲に包含されることが意図されている。
Claims (25)
- 腫瘍を有する被験体を処置するための組成物であって、該組成物は、GITR結合抗体またはその抗原結合フラグメントを含み、該組成物は治療と組み合わせて投与されることを特徴とし、
該GITR結合抗体または該抗原結合フラグメントは、エフェクターT細胞アゴニスト活性を有し、該治療は該組成物の投与の前に少なくとも1回投与されることを特徴とし、
該治療は、該被験体における癌細胞死を生じさせるかまたは該被験体における癌細胞に対して抗増殖作用を及ぼし、該治療は化学療法剤を含み、そして、該組成物は、該治療と相乗的に作用する、組成物。 - 前記組成物および前記治療が前記被験体における腫瘍増殖の抑制をもたらす、請求項1に記載の組成物。
- 前記組成物および前記治療が前記被験体における腫瘍の大きさの減少をもたらす、請求項1に記載の組成物。
- 前記組成物および前記治療が前記被験体における腫瘍数の減少をもたらす、請求項1に記載の組成物。
- 前記組成物および前記治療が前記被験体における腫瘍量を減少させる、請求項1に記載の組成物。
- 前記組成物および前記治療が前記被験体の生存を延長させる、請求項1に記載の組成物。
- 前記治療がさらに放射線を含む、請求項1〜6のいずれかに記載の組成物。
- 前記化学療法剤が、代謝拮抗薬、微小管形成に影響を及ぼす作用物質、アルキル化剤および細胞障害性抗生物質からなる群より選択される、請求項1に記載の組成物。
- 前記代謝拮抗薬がヌクレオシド類似体である、請求項8に記載の組成物。
- 前記代謝拮抗薬が、アミノプテリン、メトトレキサート、ペメトレキセド、ラルチトレキセド、クラドリビン、クロファラビン、フルダラビン、メルカプトプリン、ペントスタチン、チオグアニン、カペシタビン、シタラビン、フルオロウラシル、フロクスウリジンおよびゲムシタビンからなる群より選択される、請求項8に記載の組成物。
- 前記微小管形成に影響を及ぼす作用物質が、パクリタキセル、ドセタキセル、ビンクリスチン、ビンブラスチン、ビンデシン、ビノレルビン、タキソテール、エトポシドおよびテニポシドからなる群より選択される、請求項8に記載の組成物。
- 前記アルキル化剤がシクロホスファミドである、請求項8に記載の組成物。
- 前記細胞障害性抗生物質がトポイソメラーゼII阻害剤である、請求項8に記載の組成物。
- 前記トポイソメラーゼII阻害剤がドキソルビシンである、請求項13に記載の組成物。
- 前記GITR結合抗体または前記抗原結合フラグメントが、ヒト化抗体またはヒト化抗原結合フラグメントである、請求項1〜14のいずれかに記載の組成物。
- 前記ヒト化抗体または前記ヒト化抗原結合フラグメントが、配列番号1、2、4、5、6および7に示すかまたは配列番号1、3、4、5、6および7に示すCDRを含む、請求項15に記載の組成物。
- 前記GITR結合抗体または前記抗原結合フラグメントがキメラ抗体またはキメラ抗原結合フラグメントである、請求項1〜14のいずれかに記載の組成物。
- 前記腫瘍が固形腫瘍である、請求項1〜17のいずれかに記載の組成物。
- 前記腫瘍が結腸腫瘍または黒色腫である、請求項1〜18のいずれかに記載の組成物。
- 前記腫瘍が転移性である、請求項1〜19のいずれかに記載の組成物。
- (a)包装材料、
(b)GITR結合抗体またはその抗原結合フラグメント、および
(c)GITR結合抗体または該抗原結合フラグメントが治療と共に投与できること、を指示する、該包装材料内に含まれるラベルまたは添付文書
を含むキットであって、該GITR結合抗体または該抗原結合フラグメントは、エフェクターT細胞アゴニスト活性を有し、該治療は該GITR結合抗体または該抗原結合フラグメントの投与の前に少なくとも1回投与され、該治療は、該被験体における癌細胞死を生じさせるかまたは該被験体における癌細胞に対して抗増殖作用を及ぼし、該治療は化学療法剤を含み、かつ、該抗体または該抗原結合フラグメントは、該治療と相乗的に作用する、キット。 - 前記治療がさらに放射線を含む、請求項21に記載のキット。
- 前記GITR結合抗体または前記抗原結合フラグメントが、ヒト化抗体またはヒト化抗原結合フラグメントである、請求項21〜22のいずれかに記載のキット。
- 前記ヒト化抗体または前記ヒト化抗原結合フラグメントが、配列番号1、2、4、5、6および7に示すかまたは配列番号1、3、4、5、6および7に示すCDRを含む、請求項23に記載のキット。
- 前記GITR結合抗体または前記抗原結合フラグメントがキメラ抗体またはキメラ抗原結合フラグメントである、請求項21〜24のいずれかに記載のキット。
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EP2175884B8 (en) | 2017-02-22 |
WO2009009116A3 (en) | 2009-03-26 |
DK2175884T3 (en) | 2016-09-26 |
ES2591281T3 (es) | 2016-11-25 |
AU2008275589B2 (en) | 2013-11-21 |
CA2693677C (en) | 2018-02-13 |
EP3124046A1 (en) | 2017-02-01 |
US20140220002A1 (en) | 2014-08-07 |
JP2010533184A (ja) | 2010-10-21 |
EP2175884B1 (en) | 2016-06-15 |
AU2008275589A1 (en) | 2009-01-15 |
JP2019006833A (ja) | 2019-01-17 |
US8591886B2 (en) | 2013-11-26 |
ES2776406T3 (es) | 2020-07-30 |
EP2175884A4 (en) | 2013-02-27 |
PT2175884T (pt) | 2016-09-21 |
US20190030162A1 (en) | 2019-01-31 |
US20160324963A1 (en) | 2016-11-10 |
JP2016204387A (ja) | 2016-12-08 |
JP2014169327A (ja) | 2014-09-18 |
CN101801413A (zh) | 2010-08-11 |
EP2175884A2 (en) | 2010-04-21 |
US9241992B2 (en) | 2016-01-26 |
WO2009009116A2 (en) | 2009-01-15 |
CA2693677A1 (en) | 2009-01-15 |
US20090136494A1 (en) | 2009-05-28 |
HK1143323A1 (zh) | 2010-12-31 |
EP3124046B1 (en) | 2019-12-25 |
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