JP6917681B2 - 腫瘍性疾患のための治療 - Google Patents
腫瘍性疾患のための治療 Download PDFInfo
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- JP6917681B2 JP6917681B2 JP2016100753A JP2016100753A JP6917681B2 JP 6917681 B2 JP6917681 B2 JP 6917681B2 JP 2016100753 A JP2016100753 A JP 2016100753A JP 2016100753 A JP2016100753 A JP 2016100753A JP 6917681 B2 JP6917681 B2 JP 6917681B2
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Description
本願は、2010年8月23日出願の米国特許仮出願第61/376,097号、2010年10月26日出願の同第61/406,759号、2010年11月8日出願の同第61/411,183号及び2011年4月29日出願の同第61/480,635号(これらは全て、それらの全体において参照により本明細書中に組み込まれる)の優先権を主張する。
該当せず。
従来の免疫学的及び分子生物学的技術を含む方法を本明細書中で記載する。免疫学的方法(例えば、抗原−Ab複合体の検出及び局在に関するアッセイ、免疫沈降、免疫ブロッティングなど)は、一般に当技術分野で公知であり、Current Protocols in Immunology,Coligan et al.,ed.,John Wiley & Sons,New Yorkなどの、手法に関する専門書に記載されている。分子生物学の技術は、Molecular Cloning:A Laboratory Manual,2nd ed.,vol.1−3,Sambrook et al.,ed.,Cold Spring Harbor Laboratory Press,Cold Spring Harbor,N.Y.,2001;及びCurrent Protocols in Molecular Biology,Ausubel et al.,ed.,Greene Publishing and Wiley−Interscience,New Yorkなどの専門書に詳細に記載されている。Abに関する方法は、Handbook of Therapeutic Abs,Dubel,S.,ed.,Wiley−VCH,2007に記載されている。医学的処置の一般的方法は、McPhee及びPapadakis,Current Medical Diagnosis and Treatment 2010,49th Edition,McGraw−Hill Medical,2010;及びFauci et al.,Harrison’s Principles of Internal Medicine,17th Edition,McGraw−Hill Professional,2008に記載されている。
本明細書中に記載の組成物及び方法は、対象における腫瘍関連疾患の少なくとも1つの特徴を改善するために有効な量の抗IL−1α Abを含む医薬組成物を対象に投与することによって哺乳動物対象において腫瘍関連疾患を治療するために有用である。この哺乳動物対象は、ヒト、イヌ、ネコ、ウマ、ウシ、ヒツジ、ヤギ及びブタを含む、腫瘍関連疾患に罹患しているあらゆるものであってもよい。ヒト対象は、男性、女性、成人、小児、高齢者(65歳以上)及び他の疾患に罹患している者であってもよい。特に好ましい対象は、化学療法、放射線療法、外科手術及び/又は生物学的薬剤での治療後に疾患が進行した対象である。抗IL−1αAbでの治療に感受性がある、あらゆるタイプの腫瘍関連疾患が標的となり得る。抗IL−1αAbの投与は、結直腸腫瘍(例えば、KRAS突然変異がある結直腸癌)、EBV関連新生物、例えば鼻咽頭癌又はバーキットリンパ腫など、NSCLC及び血液細胞癌、例えばキャッスルマン病におけるものなど、を治療するために特に有効であると思われる。IL−1αを発現する腫瘍又はIL−1α炎症細胞が浸潤している腫瘍を伴う疾患もまた標的となってもよい。改善させようとする腫瘍関連疾患の特有の特徴は、腫瘍サイズ(例えば、T0、Tis又はT1−4)、転移の状態(例えば、M0、M1)、観察される腫瘍数、リンパ節転移(例えば、N0、N1−4、Nx)、グレード(即ちグレード1、2、3又は4)、ステージ(例えば、0、I、II、III又はIV)、細胞又は体液中でのある一定のマーカーの存在もしくは濃度(例えば、AFP、B2M、β−HCG、BTA、CA15−3、CA27.29、CA125、CA72.4、CA19−9、カルシトニン、CEA、クロムグライニン(chromgrainin)A、EGFR、ホルモン受容体、HER2、HCG、免疫グロブリン、NSE、NMP22、PSA、PAP、PSMA、S−100、TA−90及びサイログロブリン)及び/又は関連病態(例えば腹水又は浮腫)又は症状(例えば、悪液質、発熱、食欲不振又は疼痛)であり得る。改善は、%により評価可能な場合は、少なくとも5、10、15、20、25、30、40、50、60、70、80又は90%であり得る(例えば腫瘍の体積又は線寸法)。
IL−1αに特異的に結合し、対象において腫瘍関連疾患の特徴を軽減する何らかの適切なタイプのAb又は他の生物学的薬剤(例えば、IL−1受容体などのIL−1α結合成分を含む融合タンパク質)が本発明において使用され得る。例えば、使用される抗IL−1αAbは、mAb、ポリクローナルAb、mAbの混合物又はAb断片又はscFvなどの改変Ab様分子であってもよい。AbのKaは、好ましくは少なくとも1×109M−1以上(例えば、9×1010M−1、8×1010M−1、7×1010M−1、6×1010M−1、5×1010M−1、4×1010M−1、3×1010M−1、2×1010M−1又は1×1010M−1超)である。好ましい実施態様において、本発明は、(i)ヒトIL−1α に対する非常に高い結合親和性(例えば少なくともナノ又はピコモルレベル)を示す抗原結合可変領域と、(ii)定常領域と、を含む完全ヒトmAbを利用する。ヒトAbは、好ましくはIgG1であるが、IgM、IgAもしくはIgEなどの様々なアイソタイプ又はIgG2、IgG3もしくはIgG4などのサブクラスなどであってもよい。特に有用なmAbの一例は、2009年6月1日出願の米国特許出願第12/455,458号明細書に記載される、MABp1、IL−1α特異的IgG1 mAbである。他の有用なmAbは、MABp1の少なくとも1つの、しかし好ましくは全てのCDRを含むものである。
投与方式及び経路ならびに標準的な薬務に基づいて選択される医薬的に許容可能な担体(例えば滅菌食塩水)中で本抗IL−1αAb組成物を動物又はヒトに投与することができる。医薬的に許容可能な担体の一覧ならびに製剤処方は、この分野の標準的な教科書であるRemington’s Pharmaceutical Sciences及びUSP/NFで見出すことができる。本組成物に他の物質を添加してもよく、本組成物を安定化し及び/又は保存するために、及び/又は対象へのそれらの投与を容易にするために、他の段階が取り入れられる。
Xilonix(商標)は、安定化等張緩衝液(pH6.4)中の15mg/mL MAbp1の滅菌注射液製剤である。各10mLのタイプIホウケイ酸ガラス血清バイアルにこの製剤が5mL含有され、20mmの大協精工Flurotecブチルゴム栓及びフリップオフアルミシールにより密封されている。本製品は5±3℃で保管し、室温に出してもよい。本製剤の正確な組成を下記で示す。
適切なシリンジを用いて、計算した体積を薬物(mAb)含有バイアルから抜き取る。次いで、100mLの生理食塩水(0.9%NaCl)を含有する小型のIVバッグに薬物を注入し、転倒混合する。希釈した製剤は投与前に室温で3時間保管することができ、輸液反応の兆候について対象を監視しながら、1時間にわたり点滴する。点滴セットに保持され得る製品を全て送達させるために、最低でも30mLの生理食塩水で点滴の洗い流しを行う。
ヒト対象は、転移性結直腸癌(KRAS突然変異陽性)と診断された63歳女性であった。Xilonix(商標)での治療前に、対象は右半結腸切除術を受け、報告によると、T3N1MXに病期分類された。その後、本対象は、約6カ月にわたり全部で12サイクルのFOLFOXによる補助化学療法を受けた。FOLFOX治療終了から約2カ月後に行ったPET CTスキャンから、本対象の骨盤中で腫瘤が明らかになった。明らかに腫瘍由来である閉塞性水腎症が原因で、尿管ステントを留置する際に本対象を入院させた。本対象は、その後すぐ、FOLFIRI及びAvastinを開始し、8サイクルの治療を受けた。次に、本対象に対してPET CTスキャンを行って病期分類を再び行い、骨盤中で病変が確認され、転移性疾患と合致する肺内小結節も明らかになった。胸部、腹部及び骨盤のCTスキャンから、12cmの骨盤内腫瘤、2cmの大網腫瘤及び尿管ステントがある右側での水腎症が明らかになった。本対象は、さらに2サイクルのFOLFIRI及びAvastin投与を受けた。その後のPET CTスキャンから、両側性肺内結節の進行が示された。次いで、本対象に対してイリノテカン及びErbitux(登録商標)(セツキシマブ)療法を開始した。フォローアップPET CTスキャンから、肺における疾患進行が明らかになった。
対象は、組織学的亜型リンパ上皮腫(古い専門用語)又は非角化癌があるEBV+(エプスタインバーウイルス)の鼻咽頭癌に罹患している47歳の中国系男性であった。本対象は、シスプラチン、5−FU、放射線療法、Taxotere(登録商標)(ドセタキセル)、Gemzar(登録商標)(ゲムシタビン)、Xeloda(登録商標)(カペシタビン)、EBV標的T細胞養子免疫伝達(Adoptive EBV−directed T cell transfer)及び、Gemzar(登録商標)(ゲムシタビン)と組み合わせたCymevene(登録商標)(ガンシクロビル)による治療を以前に受けていた。治療開始前に、本患者は、倦怠感、発熱及び発汗があり、腹水に対する治療のための穿刺を頻繁に受けていた。
対象は、キャッスルマン病に罹患した55歳女性であった(POEMS症状群として知られる変異型)。本対象の症状には、倦怠感、浮腫及び神経痛が含まれた。Rituxan(登録商標)(リツキシマブ)及び治験抗IL−6療法による以前の治療は奏効しなかった。MABp1(0.75mg/kg)の点滴を21日ごとに全部で4回、本対象に行った。次のサイクルにおいて本対象の用量を1.25mg/kgに増量した。
対象は、穿刺吸引により転移性非小細胞肺癌と診断された病歴がある84歳女性であった。診断から3カ月後、本対象は、疾患進行が指摘された時点で8カ月にわたるTarceva(登録商標)(エルロチニブ)での治療を開始した。次いで、病因不明の腎不全の発症により治療が中止された時点で8カ月にわたりAlimta(登録商標)(ペルメトレキセド(Permetrexed))により11サイクル、本対象に対する治療が行われた。6カ月後、進行性疾患が指摘され、本患者を再びTarceva(登録商標)(エルロチニブ)で3カ月間治療した。その時点で、本患者のCATスキャンから、肺においてさらに進行性疾患が示され、右上葉の腫瘤サイズが拡大し、転移と合致する肺内結節が見られ、胸腔内リンパ節肥大が増大した。
対象は、第0日にKRAS−陽性非小細胞(腺癌)肺癌と診断された52歳女性であった。第14日からのPET/CTスキャンから、肺、肺門節、右鼠径リンパ節、右副腎、右第四肋骨及び仙腸関節への疾患転移とともに、4x3.5cmの左上葉腫瘤が明らかになった。本対象は、スキャンから数週間後、カルボプラチン、パクリタキセル及びベバシズマブでの治療を開始した。本対象の初期反応は良好であり、5サイクルを終了した後、初回治療から約5カ月で進行が見られた。次の6カ月間にわたり、ドセタキセルで3サイクル及びカルボプラチン+ペメトレキセドで1サイクル、本対象を治療した。この治療にもかかわらず、本対象は病状が進行し続けた。
本明細書の詳細な説明とともに本発明を記載してきたが、前述の記載は、例示するものであり、本発明の範囲を限定するものではなく、本発明の範囲が付属の特許請求の範囲によって定められるものであることを理解されたい。その他の態様、長所及び変更形態は次の特許請求の範囲内である。
Claims (4)
- 化学療法、放射線療法又は生物学的薬剤での治療後に進行した癌を有するヒト患者において進行性癌を安定化させるための医薬組成物であって、前記医薬組成物が、抗ヒトIL−1α抗体を含み、前記ヒト患者に少なくとも癌の進行が安定化するまで繰り返して投与されるものであり、前記抗ヒトIL−1α抗体が、少なくとも1×10 9 M −1 のKaでヒトIL−1αに結合するモノクローナル抗体であることを特徴とする医薬組成物。
- 請求項1に記載の医薬組成物において、前記癌が転移性結直腸癌であることを特徴とする医薬組成物。
- 請求項2に記載の医薬組成物において、前記医薬組成物の投与が前記ヒト患者中のCEA腫瘍マーカーのレベルを低下させることを特徴とする医薬組成物。
- 請求項1に記載の医薬組成物において、前記癌が転移性非小細胞肺癌であることを特徴とする医薬組成物。
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