JP2018520996A - 癌のための治療方法及び診断方法 - Google Patents
癌のための治療方法及び診断方法 Download PDFInfo
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Abstract
Description
本出願は、ASCII形式で電子的に提出された配列表を含み、参照によりその全体が本明細書に組み込まれる。2016年5月11日に作成された該ASCIIコピーは、50474−111WO3_Sequence_Listing_5_11_16_ST25という名称であり、23,626バイトのサイズである。
本発明は、癌、例えば非小細胞肺癌のための治療方法及び診断方法、ならびに組成物を提供する。本発明は、患者から得られた試料中(例えば、患者から得られた腫瘍試料中の腫瘍細胞中及び腫瘍浸潤免疫細胞中)の本発明のバイオマーカー、例えばPD−L1の発現レベルの判定が、癌に罹患している患者の治療において、癌に罹患している患者の診断において、癌を有する患者がPD−L1軸結合アンタゴニスト(例えば、抗PD−L1抗体、例えば、MPDL3280A)を含む抗癌療法での治療に応答する可能性が高いかどうかを判定するため、PD−L1軸結合アンタゴニスト(例えば、抗PD−L1抗体、例えば、MPDL3280A)を含む抗癌療法の治療効果を最適化するため、かつ/またはPD−L1軸結合アンタゴニスト(例えば、抗PD−L1抗体、例えば、MPDL3280A)を含む抗癌療法のための患者選択のために有用であるという発見に少なくとも部分的に基づく。
本明細書に記載の本発明の態様及び実施形態が、態様及び実施形態「を含む」、「からなる」、及び「から本質的になる」を含むことが理解される。本明細書で使用する場合、単数形「a」、「an」、及び「the」は、別途指示されない限り、複数の対象を含む。
100×分数X/Y
式中、Xは、配列アライメントプログラムALIGN−2によってそのプログラムのAとBとの整列において完全な一致としてスコア化されたアミノ酸残基の数であり、Yは、Bにおけるアミノ酸残基の総数である。アミノ酸配列Aの長さがアミノ酸配列Bの長さと等しくない場合、AのBに対するアミノ酸配列同一性%は、BのAに対するアミノ酸配列同一性%とは等しくないことが理解される。別途具体的に示されない限り、本明細書で使用される全てのアミノ酸配列同一性%値は、直前の段落に記載されるようにALIGN−2コンピュータプログラムを使用して得られる。
A.診断方法
癌(例えば、非小細胞肺癌)に罹患している患者が、PD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いかどうかを判定する方法が本明細書に提供される。癌(例えば、非小細胞肺癌)に罹患している患者のPD−L1軸結合アンタゴニストを含む治療に対する応答性を予測する方法も本明細書に提供される。癌(例えば、非小細胞肺癌)に罹患している患者のための療法を選択する方法が本明細書にさらに提供される。前述の方法のいずれも、本明細書に提供されるバイオマーカーの発現レベル、例えば、腫瘍試料中、例えば、腫瘍浸潤免疫細胞中及び/または腫瘍細胞中のPD−L1発現に基づいてもよい。方法はいずれも、患者にPD−L1軸結合アンタゴニスト(例えば、C項の記載されるような以下の「PD−L1軸結合アンタゴニスト」)を患者に投与することをさらに含んでもよい。方法はいずれも、有効量の第2の治療剤を患者に投与することをさらに含んでもよい。
本発明は、癌(例えば、非小細胞肺癌)に罹患している患者を治療する方法を提供する。いくつかの事例では、本発明の方法は、PD−L1軸結合アンタゴニストを含む抗癌療法剤を患者に投与することを含む。本明細書に記載される(例えば、以下のC項、「PD−L1軸結合アンタゴニスト」を参照されたい)か、または当該技術分野で既知のPD−L1軸結合アンタゴニストのいずれも、本方法に使用され得る。いくつかの事例では、該方法は、患者から得られた試料中の、本明細書に記載されるバイオマーカーの存在及び/または発現レベルを判定することと、例えば、本明細書に記載される(例えば、A項、「診断方法」または以下の実施例に記載されるもの)か、または当該技術分野で既知の方法を使用して、試料中のバイオマーカーの存在及び/または発現レベルに基づいて抗癌療法剤を患者に投与することとを伴う。いくつかの実施形態では、バイオマーカーは、PD−L1である。
治療有効量のPD−L1軸結合アンタゴニストを患者に投与することを含む、患者における癌(例えば、非小細胞肺癌)を治療するか、またはその進行を遅らせる方法が本明細書に提供される。癌(例えば、非小細胞肺癌)に罹患している患者が、PD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いかどうかを判定する方法が本明細書に提供される。癌(例えば、非小細胞肺癌)に罹患している患者のPD−L1軸結合アンタゴニストを含む治療に対する応答性を予測する方法が本明細書に提供される。癌(例えば、非小細胞肺癌)に罹患している患者のための療法を選択する方法が本明細書に提供される。前述の方法のいずれも、本明細書に提供されるバイオマーカーの発現レベル、例えば、腫瘍試料中、例えば、腫瘍浸潤免疫細胞中及び/または腫瘍細胞中のPD−L1発現に基づいてもよい。
(a)重鎖配列は、重鎖配列
と少なくとも85%、少なくとも90%、少なくとも91%、少なくとも92%、少なくとも93%、少なくとも94%、少なくとも95%、少なくとも96%、少なくとも97%、少なくとも98%、少なくとも99%、または100%の配列同一性を有し、かつ
(b)軽鎖配列は、軽鎖配列
と少なくとも85%、少なくとも90%、少なくとも91%、少なくとも92%、少なくとも93%、少なくとも94%、少なくとも95%、少なくとも96%、少なくとも97%、少なくとも98%、少なくとも99%、または100%の配列同一性を有する。
(a)重鎖配列は、重鎖配列
EVQLVESGGGLVQPGGSLRLSCAASGFTFSDSWIHWVRQAPGKGLEWVAWISPYGGSTYYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCARRHWPGGFDYWGQGTLVTVSA(配列番号3)と少なくとも85%、少なくとも90%、少なくとも91%、少なくとも92%、少なくとも93%、少なくとも94%、少なくとも95%、少なくとも96%、少なくとも97%、少なくとも98%、少なくとも99%、または100%の配列同一性を有し、かつ
(b)軽鎖配列は、軽鎖配列
DIQMTQSPSSLSASVGDRVTITCRASQDVSTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQYLYHPATFGQGTKVEIKR(配列番号4)と少なくとも85%、少なくとも90%、少なくとも91%、少なくとも92%、少なくとも93%、少なくとも94%、少なくとも95%、少なくとも96%、少なくとも97%、少なくとも98%、少なくとも99%、または100%の配列同一性を有する。
さらに式中、X1は、DまたはGであり、X2は、SまたはLであり、X3は、TまたはSである。具体的な一態様において、X1は、Dであり、X2は、Sであり、X3は、Tである。別の態様において、ポリペプチドは、以下の式に従うHVR間に並置された可変領域重鎖フレームワーク配列をさらに含む:(FR−H1)−(HVR−H1)−(FR−H2)−(HVR−H2)−(FR−H3)−(HVR−H3)−(FR−H4)。なお別の態様において、フレームワーク配列は、ヒトコンセンサスフレームワーク配列由来である。さらなる一態様において、フレームワーク配列は、VH下位群IIIコンセンサスフレームワークである。なおさらなる一態様において、フレームワーク配列のうちの少なくとも1つは、以下のものである:
式中、X4は、DまたはVであり、X5は、VまたはIであり、X6は、SまたはNであり、X7は、AまたはFであり、X8は、VまたはLであり、X9は、FまたはTであり、X10は、YまたはAであり、X11は、Y、G、F、またはSであり、X12は、L、Y、F、またはWであり、X13は、Y、N、A、T、G、F、またはIであり、X14は、H、V、P、T、またはIであり、X15は、A、W、R、P、またはTである。なおさらなる態様において、X4は、Dであり、X5は、Vであり、X6は、Sであり、X7は、Aであり、X8は、Vであり、X9は、Fであり、X10は、Yであり、X11は、Yであり、X12は、Lであり、X13は、Yであり、X14は、Hであり、X15は、Aである。
(a)重鎖は、HVR−H1、HVR−H2、及びHVR−H3を含み、さらに、
(b)軽鎖は、HVR−L1、HVR−L2、及びHVR−L3を含み、さらに、
式中、X1は、DまたはGであり、X2は、SまたはLであり、X3は、TまたはSであり、X4は、DまたはVであり、X5は、VまたはIであり、X6は、SまたはNであり、X7は、AまたはFであり、X8は、VまたはLであり、X9は、FまたはTであり、X10は、YまたはAであり、X11は、Y、G、F、またはSであり、X12は、L、Y、F、またはWであり、X13は、Y、N、A、T、G、F、またはIであり、X14は、H、V、P、T、またはIであり、X15は、A、W、R、P、またはTである。具体的な態様において、X1は、Dであり、X2は、Sであり、X3は、Tである。別の態様において、X4は、Dであり、X5は、Vであり、X6は、Sであり、X7は、Aであり、X8は、Vであり、X9は、Fであり、X10は、Yであり、X11は、Yであり、X12は、Lであり、X13は、Yであり、X14は、Hであり、X15は、Aである。なお別の態様において、X1は、Dであり、X2は、Sであり、X3は、Tであり、X4は、Dであり、X5は、Vであり、X6は、Sであり、X7は、Aであり、X8は、Vであり、X9は、Fであり、X10は、Yであり、X11は、Yであり、X12は、Lであり、X13は、Yであり、X14は、Hであり、X15は、Aである。
(a)重鎖は、それぞれ、GFTFSDSWIH(配列番号19)、AWISPYGGSTYYADSVKG(配列番号20)、及びRHWPGGFDY(配列番号21)に対して少なくとも85%の配列同一性を有する、HVR−H1、HVR−H2、及びHVR−H3配列をさらに含むか、または、
(b)軽鎖は、それぞれ、RASQDVSTAVA(配列番号22)、SASFLYS(配列番号23)、及びQQYLYHPAT(配列番号24)に対して少なくとも85%の配列同一性を有する、HVR−L1、HVR−L2、及びHVR−L3配列をさらに含む。
(a)重鎖配列は、重鎖配列
EVQLVESGGGLVQPGGSLRLSCAASGFTFSDSWIHWVRQAPGKGLEWVAWISPYGGSTYYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCARRHWPGGFDYWGQGTLVTVSS(配列番号25)に対して少なくとも85%の配列同一性を有し、かつ/または
(b)軽鎖配列は、軽鎖配列
DIQMTQSPSSLSASVGDRVTITCRASQDVSTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQYLYHPATFGQGTKVEIKR(配列番号4)に対して少なくとも85%の配列同一性を有する。
(c)重鎖は、それぞれ、GFTFSDSWIH(配列番号19)、AWISPYGGSTYYADSVKG(配列番号20)、及びRHWPGGFDY(配列番号21)に対して少なくとも85%の配列同一性を有する、HVR−H1、HVR−H2、及びHVR−H3配列をさらに含み、かつ/または、
(d)軽鎖は、それぞれ、RASQDVSTAVA(配列番号22)、SASFLYS(配列番号23)、及びQQYLYHPAT(配列番号24)に対して少なくとも85%の配列同一性を有する、HVR−L1、HVR−L2、及びHVR−L3配列をさらに含む。
(a)重鎖配列は、重鎖配列
EVQLVESGGGLVQPGGSLRLSCAASGFTFSDSWIHWVRQAPGKGLEWVAWISPYGGSTYYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCARRHWPGGFDYWGQGTLVTVSSASTK(配列番号26)に対して少なくとも85%の配列同一性を有するか、または
(b)軽鎖配列は、軽鎖配列
DIQMTQSPSSLSASVGDRVTITCRASQDVSTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQYLYHPATFGQGTKVEIKR(配列番号4)に対して少なくとも85%の配列同一性を有する。
(a)重鎖配列は、重鎖配列
EVQLVESGGGLVQPGGSLRLSCAASGFTFSDSWIHWVRQAPGKGLEWVAWISPYGGSTYYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCARRHWPGGFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG(配列番号32)に対して少なくとも85%の配列同一性を有し、かつ/または
(b)軽鎖配列は、軽鎖配列
DIQMTQSPSSLSASVGDRVTITCRASQDVSTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQYLYHPATFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC(配列番号33)に対して少なくとも85%の配列同一性を有する。
特定の実施形態では、本明細書に提供される抗体(例えば、抗PD−L1抗体または抗PD−1抗体)は、1μM以下、100nM以下、10nM以下、1nM以下、0.1nM以下、0.01nM以下、または0.001nM以下(例えば、10−8M以下、例えば、10−8M〜10−13M、例えば、10−9M〜10−13M)の解離定数(Kd)を有する。
特定の実施形態では、本明細書に提供される抗体(例えば、抗PD−L1抗体または抗PD−1抗体)は、抗体断片である。抗体断片には、Fab、Fab’、Fab’−SH、F(ab’)2、Fv、及びscFv断片、ならびに以下に記載される他の断片が含まれるが、これらに限定されない。特定の抗体断片の概説については、Hudson et al.Nat.Med.9:129−134(2003)を参照されたい。scFv断片の概説については、例えば、Pluckthun,The Pharmacology of Monoclonal Antibodies,vol.113,Rosenburg and Moore eds.,(Springer−Verlag,New York),pp.269−315(1994)を参照されたい。WO93/16185、ならびに米国特許第5,571,894号及び同第5,587,458号も参照されたい。サルベージ受容体結合エピトープ残基を含み、増加したインビボ半減期を有するFab及びF(ab’)2断片の考察については、米国特許第5,869,046号を参照されたい。
特定の実施形態では、本明細書に提供される抗体(例えば、抗PD−L1抗体または抗PD−1抗体)は、キメラ抗体である。特定のキメラ抗体は、例えば、米国特許第4,816,567号、及びMorrison et al.Proc.Natl.Acad.Sci.USA,81:6851−6855(1984))に記載されている。一例において、キメラ抗体は、非ヒト可変領域(例えば、マウス、ラット、ハムスター、ウサギ、または非ヒト霊長類、例えばサルに由来する可変領域)及びヒト定常領域を含む。さらなる例において、キメラ抗体は、そのクラスまたはサブクラスが、親抗体のクラスまたはサブクラスから変化した「クラススイッチした」抗体である。キメラ抗体は、その抗原結合断片を含む。
特定の実施形態では、本明細書に提供される抗体(例えば、抗PD−L1抗体または抗PD−1抗体)は、ヒト抗体である。ヒト抗体は、当該技術分野で既知の様々な技法を使用して産生され得る。ヒト抗体は、概して、van Dijk and van de Winkel,Curr.Opin.Pharmacol.5:368−74(2001)及びLonberg,Curr.Opin.Immunol.20:450−459(2008)に記載されている。
本発明の抗体(例えば、抗PD−L1抗体及び抗PD−1抗体)は、所望の活性(複数可)を有する抗体についてコンビナトリアルライブラリをスクリーニングすることによって単離され得る。例えば、ファージディスプレイライブラリを生成し、所望の結合特性を保有する抗体についてかかるライブラリをスクリーニングするための多様な方法が当該技術分野で既知である。かかる方法は、例えば、Hoogenboom et al.in Methods in Molecular Biology 178:1−37(O’Brien et al.,ed.,Human Press,Totowa,NJ,2001)に概説され、例えば、McCafferty et al.,Nature 348:552−554、Clackson et al.,Nature 352:624−628(1991)、Marks et al.,J.Mol.Biol.222:581−597(1992)、Marks and Bradbury,Methods in Molecular Biology 248:161−175(Lo,ed.,Human Press,Totowa,NJ,2003)、Sidhu et al.,J.Mol.Biol.338(2):299−310(2004)、Lee et al.,J.Mol.Biol.340(5):1073−1093(2004)、Fellouse,Proc.Natl.Acad.Sci.USA 101(34):12467−12472(2004)、及びLee et al.,J.Immunol.Methods 284(1−2):119−132(2004)にさらに記載されている。
上記の態様のいずれか1つにおいて、本明細書に提供される抗体(例えば、抗PD−L1抗体または抗PD−1抗体)は、多重特異性抗体、例えば、二重特異性抗体であり得る。多重特異性抗体は、少なくとも2つの異なる部位への結合特異性を有するモノクローナル抗体である。特定の実施形態では、本明細書に提供される抗体は、多重特異性抗体、例えば、二重特異性抗体である。特定の実施形態では、結合特異性の一方は、PD−L1へのものであり、他方は、任意の他の抗原へのものである。特定の実施形態では、二重特異性抗体は、PD−L1の2つの異なるエピトープに結合し得る。二重特異性抗体を使用して、PD−L1を発現する細胞に細胞毒性剤を局所化することもできる。二重特異性抗体は、全長抗体または抗体断片として調製することができる。
特定の実施形態では、本発明の抗体(例えば、抗PD−L1抗体及び抗PD−1抗体)のアミノ酸配列変異型が企図される。例えば、抗体の結合親和性及び/または他の生物学的特性を改善することが望ましい場合がある。抗体のアミノ酸配列変異型は、抗体をコードするヌクレオチド配列に適切な修飾を導入することによって、またはペプチド合成によって調製され得る。かかる修飾には、例えば、抗体のアミノ酸配列内の残基からの欠失、及び/またはそれへの挿入、及び/またはその置換が含まれる。欠失、挿入、及び置換を任意に組み合わせて最終構築物を得ることができるが、但し、その最終構築物が、所望の特性、例えば、抗原結合性を保有することを条件とする。
特定の実施形態では、1つ以上のアミノ酸置換を有する抗体変異型が提供される。置換型変異誘発の目的の部位には、HVR及びFRが含まれる。保存的置換は、表1の「保存的置換」という見出しの下に示される。より実質的な変化は、表1の「例示的な置換」という見出しの下に示され、アミノ酸側鎖クラスを参照して以下にさらに記載される。アミノ酸置換は、目的の抗体中に導入され得、その産物は、所望の活性、例えば、保持/改善された抗原結合、減少した免疫原性、または改善されたADCCもしくはCDCについてスクリーニングされ得る。
表1.例示的、かつ好ましいアミノ酸置換
アミノ酸は、一般的な側鎖特性に従って群分けされ得る。
(1)疎水性:ノルロイシン、Met、Ala、Val、Leu、Ile、
(2)中性親水性:Cys、Ser、Thr、Asn、Gln、
(3)酸性:Asp、Glu、
(4)塩基性:His、Lys、Arg、
(5)鎖配向に影響を及ぼす残基:Gly、Pro、
(6)芳香族:Trp、Tyr、Phe。
特定の実施形態では、本発明の抗体を改変して、抗体がグリコシル化する程度を増加または減少させることができる。本発明の抗体へのグリコシル化部位の付加または欠失は、1つ以上のグリコシル化部位を作り出すかまたは除去するように、アミノ酸配列を改変することによって簡便に達成することができる。
特定の実施形態では、1つ以上のアミノ酸修飾が、本発明の抗体のFc領域内に導入され得、それによりFc領域変異型を生成され得る。Fc領域変異型は、1つ以上のアミノ酸位にアミノ酸修飾(例えば、置換)を含むヒトFc領域配列(例えば、ヒトIgG1、IgG2、IgG3、またはIgG4 Fc領域)を含み得る。
特定の実施形態では、抗体の1つ以上の残基が、システイン残基で置換されている、システイン操作された抗体、例えば、「thioMab」を作製することが望ましい場合がある。特定の実施形態では、置換された残基は、抗体の利用しやすい部位で生じる。これらの残基をシステインで置換することによって、反応性のチオール基がそれにより抗体の利用しやすい部位に位置付けられ、それを使用し、抗体を他の部分、例えば薬物部分またはリンカー−薬物部分にコンジュゲートして、本明細書にさらに記載される免疫コンジュゲートを作製することができる。特定の実施形態では、以下の残基のうちの任意の1つ以上を、システインで置換することができる:軽鎖のV205(Kabat番号付け)、重鎖のA118(EU番号付け)、及び重鎖Fc領域のS400(EU番号付け)。システイン操作された抗体は、例えば、米国特許第7,521,541号に記載されるように生成され得る。
特定の実施形態では、本明細書に提供される抗体は、当該技術分野で既知であり、容易に入手可能な追加の非タンパク質性部分を含有するようにさらに修飾され得る。抗体の誘導体化に好適な部分には、水溶性ポリマーが含まれるが、これに限定されない。水溶性ポリマーの非限定的な例としては、ポリエチレングリコール(PEG)、エチレングリコール/プロピレングリコールのコポリマー、カルボキシメチルセルロース、デキストラン、ポリビニルアルコール、ポリビニルピロリドン、ポリ−1,3−ジオキソラン、ポリ−1,3,6−トリオキサン、エチレン/無水マレイン酸コポリマー、ポリアミノ酸(ホモポリマーまたはランダムコポリマーのいずれか)、及びデキストランまたはポリ(n−ビニルピロリドン)ポリエチレングリコール、プロプロピレングリコールホモポリマー、プロリプロピレンオキシド/エチレンオキシドコポリマー、ポリオキシエチル化ポリオール(例えば、グリセロール)、ポリビニルアルコール、ならびにこれらの混合物が含まれるが、これらに限定されない。ポリエチレングリコールプロピオンアルデヒドは、水中でのその安定性のため、製造時に有利であり得る。ポリマーは、任意の分子量のものであり得、分岐状または非分岐状であり得る。抗体に結合したポリマーの数は異なり得、1つ以上のポリマーが結合している場合、それらは同じかまたは異なる分子であり得る。一般に、誘導体化に使用されるポリマーの数及び/または種類は、改善される抗体の特定の特性または機能、抗体の誘導体が規定の条件下で療法に使用されるかどうかなどを含むがこれらに限定されない、検討事項に基づいて判定され得る。
本発明は、化学療法剤もしくは薬物、成長阻害剤、毒素(例えば、タンパク質毒素、細菌、真菌、植物、もしくは動物起源の酵素活性毒素、またはそれらの断片)、または放射性同位体などの1つ以上の細胞毒性剤とコンジュゲートされた、本明細書の抗体(例えば、抗PD−L1抗体または抗PD−1抗体)を含む免疫コンジュゲートも提供する。
本発明に従って使用されるPD−L1軸結合アンタゴニスト(例えば、抗PD−L1抗体(例えば、MPDL3280A))の治療用製剤は、所望の純度を有するアンタゴニストを、凍結乾燥した製剤または水溶液の形態にある任意の薬学的に許容される担体、賦形剤、または安定剤と混合することによって、保管のために調製される。製剤に関する一般情報については、例えば、Gilman et al.(eds.)The Pharmacological Bases of Therapeutics,8th Ed.,Pergamon Press,1990、A.Gennaro(ed.),Remington’s Pharmaceutical Sciences,18th Edition,Mack Publishing Co.,Pennsylvania,1990、Avis et al.(eds.)Pharmaceutical Dosage Forms:Parenteral Medications Dekker,New York,1993、Lieberman et al.(eds.)Pharmaceutical Dosage Forms:Tablets Dekker,New York,1990、Lieberman et al.(eds.),Pharmaceutical Dosage Forms:Disperse Systems Dekker,New York,1990、及びWalters(ed.)Dermatological and Transdermal Formulations(Drugs and the Pharmaceutical Sciences),Vol 119,Marcel Dekker,2002を参照されたい。
疾患または障害(例えば、非小細胞肺癌を含む癌)を有する個体または患者からの試料中のバイオマーカー(例えば、例えば、腫瘍細胞及び/または腫瘍浸潤免疫細胞におけるPD−L1発現レベル)の存在を判定するための1つ以上の試薬を含む診断用キットが本発明に提供される。いくつかの事例では、試料中のバイオマーカーの存在は、個体がPD−L1軸結合アンタゴニストで治療された際の有効性のより高い可能性を示す。いくつかの事例では、試料中のバイオマーカーの不在は、疾患を有する個体がPD−L1軸結合アンタゴニストで治療された際の有効性のより低い可能性を示す。任意で、キットには、個体が試料中のバイオマーカーを発現した場合に、キットを使用して、疾患または障害を治療するための医薬品(例えば、PD−L1軸結合アンタゴニスト、例えば抗PD−L1抗体、例えばMPDL3280A)を選択するための指示書がさらに含まれ得る。別の事例では、指示書は、個体が試料中のバイオマーカーを発現しない場合に、キットを使用して、PD−L1軸結合アンタゴニスト以外の医薬品を選択するためのものである。
免疫組織化学(IHC):ホルマリン固定パラフィン包埋組織切片を脱パラフィン化した後に抗原を回収し、遮断し、一次抗PD−L1抗体と共にインキュベートした。二次抗体とのインキュベーション及び酵素着色後、切片を対比染色し、一連のアルコール及びキシレンで脱水した後、カバースリップした。
以下のプロトコルをIHCに使用した。Ventana Benchmark XTまたはBenchmark Ultraシステムを使用して、以下の試薬及び物質を使用したPD−L1 IHC染色を行った。
一次抗体:抗PD−L1ウサギモノクローナル一次抗体
検体型:腫瘍試料のホルマリン固定パラフィン包埋(FFPE)切片
エピトープ回収条件:細胞条件付け、標準1(CC1、Ventana、カタログ番号950−124)
一次抗体条件:1/100、6.5μg/ml、36℃で16分間
希釈剤:抗体希釈緩衝液(担体タンパク質及びBRIJ(商標)−35を含有するトリス緩衝生理食塩水)
陰性対照:6.5μg/mlのナイーブウサギIgG(細胞シグナル伝達)または希釈剤のみ
検出:OptiviewまたはultraView Universal DAB検出キット(Ventana)、及び増幅キット(該当する場合)を製造業者(Ventana)の指示に従って使用した。
対比染色:VentanaヘマトキシリンII(カタログ番号790−2208)/ブルーイング試薬(カタログ番号760−2037)(それぞれ、4分間及び4分間)
Ventanaベンチマークプロトコルは、以下の通りであった:
1.パラフィン(選択)
2.脱パラフィン化(選択)
3.細胞条件付け(選択)
4.調節剤番号1(選択)
5.標準のCC1(選択)
6.Abインキュベーション温度(選択)
7.36C Ab Inc.(選択)
8.滴定(選択)
9.自動分注(一次抗体)、及びインキュベート(16分間)
10.対比染色(選択)
11.一滴の(ヘマトキシリンII)(対比染色)の適用、カバースリップの適用、インキュベート(4分間)
12.対比染色後(選択)
13.一滴の(ブルーイング試薬)(対比染色後)の適用、カバースリップの適用、インキュベート(4分間)
14.スライドを石鹸水で洗浄して油を除去する
15.スライドを水ですすぐ
16.スライドを95%エタノール、100%エタノール、さらにキシレンで脱水する(Leica自動染色機プログラム番号9)
17.スリップで覆う
腫瘍内に存在する様々な細胞型におけるPD−L1発現と、PD−L1軸結合アンタゴニストでの治療への応答との間の相関性を評価した。
表2:腫瘍浸潤免疫細胞(IC)IHC診断基準
表3:腫瘍細胞(TC)IHC診断基準
腫瘍浸潤免疫細胞及び腫瘍細胞の両方におけるPD−L1発現が、抗PD−L1抗体MPDL3280AなどのPD−L1軸結合アンタゴニストでの治療への応答をどのように予測したかを理解するために、IC3及びTC3のサブ集団を病理組織学的及び遺伝子発現分析によって研究した。
PD−L1軸結合アンタゴニスト(例えば、MPDL3280Aなどの抗PD−L1抗体)での治療のための循環薬力学及び予測バイオマーカーを評価した。
前述の発明が明確な理解のために例証及び例によって多少詳しく説明されているが、これらの説明及び例は、本発明の範囲を限定するものと解釈されるべきではない。本明細書で引用される全ての特許及び科学文献の開示は、参照によりそれらの全体が明示的に組み込まれる。
Claims (69)
- 非小細胞肺癌に罹患している患者を治療する方法であって、治療有効量のPD−L1軸結合アンタゴニストを前記患者に投与することを含み、前記患者から得られた腫瘍試料が、前記腫瘍試料中の腫瘍細胞の5%以上においてPD−L1の検出可能な発現レベルを有すると判定されている、前記方法。
- 前記患者から得られた前記腫瘍試料が、前記腫瘍試料中の前記腫瘍細胞の10%以上においてPD−L1の検出可能な発現レベルを有すると判定されている、請求項1に記載の方法。
- 前記患者から得られた前記腫瘍試料が、前記腫瘍試料中の前記腫瘍細胞の20%以上においてPD−L1の検出可能な発現レベルを有すると判定されている、請求項2に記載の方法。
- 前記患者から得られた前記腫瘍試料が、前記腫瘍試料中の前記腫瘍細胞の50%以上においてPD−L1の検出可能な発現レベルを有すると判定されている、請求項3に記載の方法。
- 前記患者から得られた前記腫瘍試料が、前記試料の10%未満を構成する腫瘍浸潤免疫細胞においてPD−L1の検出可能な発現レベルを有する、請求項1〜4のいずれか1項に記載の方法。
- 非小細胞肺癌に罹患している患者を治療する方法であって、治療有効量のPD−L1軸結合アンタゴニストを前記患者に投与することを含み、前記患者から得られた腫瘍試料が、前記腫瘍試料の5%以上を構成する腫瘍浸潤免疫細胞におけるPD−L1の検出可能な発現レベル、及び前記腫瘍試料中の腫瘍細胞の50%未満におけるPD−L1の検出可能な発現レベルを有すると判定されている、前記方法。
- 前記患者から得られた前記腫瘍試料が、前記腫瘍試料の10%以上を構成する腫瘍浸潤免疫細胞においてPD−L1の検出可能な発現レベルを有すると判定されている、請求項6に記載の方法。
- 非小細胞肺癌に罹患している患者が、PD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いかどうかを判定する方法であって、
前記患者から得られた腫瘍試料中の腫瘍細胞におけるPD−L1の発現レベルを判定することを含み、
前記腫瘍試料中の前記腫瘍細胞の5%以上におけるPD−L1の検出可能な発現レベルが、前記患者がPD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いことを示す、前記方法。 - 非小細胞肺癌に罹患している患者が、PD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いかどうかを判定する方法であって、
前記患者から得られた腫瘍試料中の腫瘍浸潤免疫細胞及び腫瘍細胞におけるPD−L1の発現レベルを判定することを含み、
前記腫瘍試料の5%以上を構成する腫瘍浸潤免疫細胞におけるPD−L1の検出可能な発現レベル、及び前記腫瘍試料中の前記腫瘍細胞の50%未満におけるPD−L1の検出可能な発現レベルが、前記患者がPD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いことを示す、前記方法。 - 非小細胞肺癌に罹患している患者の、PD−L1軸結合アンタゴニストを含む治療に対する応答性を予測する方法であって、
前記患者から得られた腫瘍試料中の腫瘍細胞におけるPD−L1の発現レベルを判定することを含み、
前記腫瘍試料中の前記腫瘍細胞の5%以上におけるPD−L1の検出可能な発現レベルが、前記患者がPD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いことを示す、前記方法。 - 非小細胞肺癌に罹患している患者の、PD−L1軸結合アンタゴニストを含む治療に対する応答性を予測する方法であって、
前記患者から得られた腫瘍試料中の腫瘍浸潤免疫細胞及び腫瘍細胞におけるPD−L1の発現レベルを判定することを含み、
前記腫瘍試料の5%以上を構成する腫瘍浸潤免疫細胞におけるPD−L1の検出可能な発現レベル、及び前記腫瘍試料中の前記腫瘍細胞の50%未満におけるPD−L1の検出可能な発現レベルが、前記患者がPD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いことを示す、前記方法。 - 前記腫瘍試料中の前記腫瘍細胞の10%以上におけるPD−L1の検出可能な発現レベルが、前記患者がPD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いことを示す、請求項8または10に記載の方法。
- 前記腫瘍試料中の前記腫瘍細胞の20%以上におけるPD−L1の検出可能な発現レベルが、前記患者がPD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いことを示す、請求項12に記載の方法。
- 前記腫瘍試料中の前記腫瘍細胞の50%以上におけるPD−L1の検出可能な発現レベルが、前記患者がPD−L1軸結合アンタゴニストを含む治療に応答する可能性が高いことを示す、請求項13に記載の方法。
- 前記方法が、前記患者から得られた前記腫瘍試料中の腫瘍浸潤免疫細胞におけるPD−L1の発現レベルを判定することをさらに含む、請求項8または10に記載の方法。
- 前記患者から得られた前記腫瘍試料が、前記試料の10%未満を構成する腫瘍浸潤免疫細胞においてPD−L1の検出可能な発現レベルを有する、請求項15に記載の方法。
- 前記患者から得られた前記腫瘍試料が、前記腫瘍試料の10%以上を構成する腫瘍浸潤免疫細胞においてPD−L1の検出可能な発現レベルを有すると判定されている、請求項9または11に記載の方法。
- 非小細胞肺癌に罹患している患者のための療法を選択する方法であって、
前記患者から得られた腫瘍試料中の腫瘍細胞におけるPD−L1の発現レベルを判定することと、
前記腫瘍試料中の前記腫瘍細胞の5%以上におけるPD−L1の検出可能な発現レベルに基づいて、前記患者のためのPD−L1軸結合アンタゴニストを含む療法を選択することと、を含む、前記方法。 - 前記方法が、前記腫瘍試料中の前記腫瘍細胞の10%以上におけるPD−L1の検出可能な発現レベルに基づいて、前記患者のためのPD−L1軸結合アンタゴニストを含む療法を選択することを含む、請求項18に記載の方法。
- 前記方法が、前記腫瘍試料中の前記腫瘍細胞の20%以上におけるPD−L1の検出可能な発現レベルに基づいて、前記患者のためのPD−L1軸結合アンタゴニストを含む療法を選択することを含む、請求項19に記載の方法。
- 前記方法が、前記腫瘍試料中の前記腫瘍細胞の50%以上におけるPD−L1の検出可能な発現レベルに基づいて、前記患者のためのPD−L1軸結合アンタゴニストを含む療法を選択することを含む、請求項20に記載の方法。
- 前記方法が、前記患者から得られた前記腫瘍試料中の腫瘍浸潤免疫細胞におけるPD−L1の発現レベルを判定することをさらに含む、請求項18〜21のいずれか1項に記載の方法。
- 前記患者から得られた前記腫瘍試料が、前記試料の10%未満を構成する腫瘍浸潤免疫細胞においてPD−L1の検出可能な発現レベルを有する、請求項22に記載の方法。
- 非小細胞肺癌に罹患している患者のための療法を選択する方法であって、
前記患者から得られた腫瘍試料中の腫瘍浸潤免疫細胞及び腫瘍細胞におけるPD−L1の発現レベルを判定することと、
前記腫瘍試料の5%以上を構成する腫瘍浸潤免疫細胞におけるPD−L1の検出可能な発現レベル、及び前記腫瘍試料中の腫瘍細胞の50%未満におけるPD−L1の検出可能な発現レベルに基づいて、前記患者のためのPD−L1軸結合アンタゴニストを含む療法を選択することと、を含む、前記方法。 - 腫瘍浸潤免疫細胞におけるPD−L1の発現レベルが、前記腫瘍試料の少なくとも10%を構成する腫瘍浸潤細胞において検出可能であると判定される、請求項24に記載の方法。
- 前記患者から得られた前記腫瘍試料が、参照腫瘍試料と比べて増加した数の上皮内及び/または間質性免疫細胞を含む、請求項6、7、9、11、17、24、及び25のいずれか1項に記載の方法。
- 前記患者から得られた前記腫瘍試料が、参照腫瘍試料と比べて増加した数のCD8+T細胞を含む、請求項6、7、9、11、17、及び24〜26のいずれか1項に記載の方法。
- 前記患者から得られた前記腫瘍試料が、参照腫瘍試料と比べて、1つ以上のB細胞関連遺伝子またはナチュラルキラー(NK)細胞関連遺伝子の発現レベルの増加を有する、請求項6、7、9、11、17、及び24〜27のいずれか1項に記載の方法。
- 前記1つ以上のB細胞関連遺伝子が、CD19、MS4A1、及びCD79Aからなる群から選択される、請求項28に記載の方法。
- 前記1つ以上のNK細胞関連遺伝子が、KLRB1、KLRC1、KLRC2、KLRC3、KLRD1、KLRF1、KLRG1、KLRK1、NCAM1、PRF1、NCR1、KIR2DL2、KIR2DL3、KIR2DL4、KIR2DS2、KIR3DL1、FCGR3A、MICA、及びMICBからなる群から選択される、請求項28に記載の方法。
- 前記患者から得られた前記腫瘍試料が、線維芽細胞及び/または筋線維芽細胞の集団を含む、請求項1〜5、8、10、12〜16、及び18〜23のいずれか1項に記載の方法。
- 前記患者から得られた前記腫瘍試料が、細胞希薄及び/または膠原化間質を含む、請求項1〜5、8、10、12〜16、18〜23、及び31のいずれか1項に記載の方法。
- 前記腫瘍試料が、参照腫瘍試料と比べて、コラーゲン、STAT1、またはMEKの発現レベルの増加を有する、請求項1〜5、8、10、12〜16、18〜23、及び32のいずれか1項に記載の方法。
- 前記腫瘍試料中の腫瘍細胞または腫瘍浸潤免疫細胞におけるPD−L1の発現レベルに基づいて、治療有効量のPD−L1軸結合アンタゴニストを前記患者に投与することをさらに含む、請求項8〜33のいずれか1項に記載の方法。
- 前記PD−L1軸結合アンタゴニストが、PD−L1結合アンタゴニスト、PD−1結合アンタゴニスト、及びPD−L2結合アンタゴニストからなる群から選択される、請求項1〜34のいずれか1項に記載の方法。
- 前記PD−L1軸結合アンタゴニストが、PD−L1結合アンタゴニストである、請求項35に記載の方法。
- 前記PD−L1結合アンタゴニストが、PD−L1の、そのリガンド結合パートナーのうちの1つ以上への結合を阻害する、請求項36に記載の方法。
- 前記PD−L1結合アンタゴニストが、PD−L1の、PD−1への結合を阻害する、請求項37に記載の方法。
- 前記PD−L1結合アンタゴニストが、PD−L1の、B7−1への結合を阻害する、請求項37に記載の方法。
- 前記PD−L1結合アンタゴニストが、PD−L1の、PD−1及びB7−1の両方への結合を阻害する、請求項37〜39のいずれか1項に記載の方法。
- 前記PD−L1結合アンタゴニストが、抗体である、請求項36〜40のいずれか1項に記載の方法。
- 前記抗体が、YW243.55.S70、MPDL3280A(アテゾリズマブ)、MDX−1105、MEDI4736(デュルバルマブ)、及びMSB0010718C(アベルマブ)からなる群から選択される、請求項41に記載の方法。
- 前記抗体が、配列番号19のHVR−H1配列、配列番号20のHVR−H2配列、及び配列番号21のHVR−H3配列を含む重鎖と、配列番号22のHVR−L1配列、配列番号23のHVR−L2配列、及び配列番号24のHVR−L3配列を含む軽鎖とを含む、請求項41に記載の方法。
- 前記抗体が、配列番号26のアミノ酸配列を含む重鎖可変領域と、配列番号4のアミノ酸配列を含む軽鎖可変領域とを含む、請求項41に記載の方法。
- 前記PD−L1軸結合アンタゴニストが、PD−1結合アンタゴニストである、請求項35に記載の方法。
- 前記PD−1結合アンタゴニストが、PD−1の、そのリガンド結合パートナーのうちの1つ以上への結合を阻害する、請求項45に記載の方法。
- 前記PD−1結合アンタゴニストが、PD−1の、PD−L1への結合を阻害する、請求項46に記載の方法。
- 前記PD−1結合アンタゴニストが、PD−1の、PD−L2への結合を阻害する、請求項46に記載の方法。
- 前記PD−1結合アンタゴニストが、PD−1の、PD−L1及びPD−L2の両方への結合を阻害する、請求項46〜48のいずれか1項に記載の方法。
- 前記PD−1結合アンタゴニストが、抗体である、請求項45〜49のいずれか1項に記載の方法。
- 前記抗体が、MDX−1106(ニボルマブ)、MK−3475(ペンブロリズマブ)、CT−011(ピディリズマブ)、MEDI−0680(AMP−514)、PDR001、REGN2810、及びBGB−108からなる群から選択される、請求項50に記載の方法。
- 前記PD−1結合アンタゴニストが、Fc融合タンパク質である、請求項45〜49のいずれか1項に記載の方法。
- 前記Fc融合タンパク質が、AMP−224である、請求項52に記載の方法。
- 有効量の第2の治療剤を前記患者に投与することをさらに含む、請求項1〜7または34〜53のいずれか1項に記載の方法。
- 前記第2の治療剤が、細胞毒性剤、成長阻害剤、放射線療法剤、血管新生阻害剤、及びこれらの組み合わせからなる群から選択される、請求項54に記載の方法。
- 前記非小細胞肺癌が、局所進行性または転移性非小細胞肺癌である、請求項1〜55のいずれか1項に記載の方法。
- 前記腫瘍試料が、ホルマリン固定及びパラフィン包埋(FFPE)腫瘍試料、保管用腫瘍試料、新鮮腫瘍試料、または凍結腫瘍試料である、請求項1〜56のいずれか1項に記載の方法。
- PD−L1の発現レベルが、タンパク質発現レベルである、請求項1〜57のいずれか1項に記載の方法。
- PD−L1の前記タンパク質発現レベルが、免疫組織化学(IHC)、免疫蛍光法、フローサイトメトリー、及びウェスタンブロットからなる群から選択される方法を使用して判定される、請求項58に記載の方法。
- PD−L1の前記タンパク質発現レベルが、IHCを使用して判定される、請求項59に記載の方法。
- PD−L1の前記タンパク質発現レベルが、抗PD−L1抗体を使用して検出される、請求項59または60に記載の方法。
- PD−L1の発現レベルが、mRNA発現レベルである、請求項1〜57のいずれか1項に記載の方法。
- PD−L1の前記mRNA発現レベルが、定量的ポリメラーゼ連鎖反応(qPCR)、逆転写qPCR(RT−qPCR)、RNA配列決定、マイクロアレイ分析、インサイツハイブリダイゼーション、及び遺伝子発現連続分析(SAGE)からなる群から選択される方法を使用して判定される、請求項62に記載の方法。
- 非小細胞肺癌に罹患している患者の治療における使用のためのPD−L1軸結合アンタゴニストであって、前記患者から得られた腫瘍試料が、前記腫瘍試料中の腫瘍細胞の5%以上においてPD−L1の検出可能な発現レベルを有すると判定されている、前記PD−L1軸結合アンタゴニスト。
- 非小細胞肺癌に罹患している患者の治療における使用のための医薬品の製造における有効量のPD−L1軸結合アンタゴニストの使用であって、前記患者から得られた腫瘍試料が、前記腫瘍試料中の前記腫瘍細胞の5%以上においてPD−L1の検出可能な発現レベルを有すると判定されている、前記使用。
- 非小細胞肺癌に罹患している患者を治療する方法における使用のための有効量のPD−L1軸結合アンタゴニストを含む組成物であって、前記患者から得られた腫瘍試料が、前記腫瘍試料中の前記腫瘍細胞の5%以上においてPD−L1の検出可能な発現レベルを有すると判定されている、前記組成物。
- 非小細胞肺癌に罹患している患者の治療における使用のためのPD−L1軸結合アンタゴニストであって、前記患者から得られた腫瘍試料が、前記腫瘍試料の5%以上を構成する腫瘍浸潤免疫細胞におけるPD−L1の検出可能な発現レベル、及び前記腫瘍試料中の腫瘍細胞の50%未満におけるPD−L1の検出可能な発現レベルを有すると判定されている、前記PD−L1軸結合アンタゴニスト。
- 非小細胞肺癌に罹患している患者の治療における使用のための医薬品の製造における有効量のPD−L1軸結合アンタゴニストの使用であって、前記患者から得られた腫瘍試料が、前記腫瘍試料の5%以上を構成する腫瘍浸潤免疫細胞におけるPD−L1の検出可能な発現レベル、及び前記腫瘍試料中の腫瘍細胞の50%未満におけるPD−L1の検出可能な発現レベルを有すると判定されている、前記使用。
- 非小細胞肺癌に罹患している患者を治療する方法における使用のための有効量のPD−L1軸結合アンタゴニストを含む組成物であって、前記患者から得られた腫瘍試料が、前記腫瘍試料の5%以上を構成する腫瘍浸潤免疫細胞におけるPD−L1の検出可能な発現レベル、及び前記腫瘍試料中の腫瘍細胞の50%未満におけるPD−L1の検出可能な発現レベルを有すると判定されている、前記組成物。
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JP7048319B2 (ja) | 2022-04-05 |
EP3294770B2 (en) | 2024-03-20 |
DK3294770T3 (da) | 2020-12-07 |
AU2016262074A1 (en) | 2017-11-09 |
CA2983282A1 (en) | 2016-11-17 |
US20180030138A1 (en) | 2018-02-01 |
EP3294770B1 (en) | 2020-10-07 |
MX2023002251A (es) | 2023-03-17 |
HK1250376A1 (zh) | 2018-12-14 |
IL295002A (en) | 2022-09-01 |
ES2835866T3 (es) | 2021-06-23 |
WO2016183326A1 (en) | 2016-11-17 |
IL255312B (en) | 2022-08-01 |
EP3294770A1 (en) | 2018-03-21 |
IL255312A0 (en) | 2017-12-31 |
AU2022203501A1 (en) | 2022-06-09 |
KR20180008449A (ko) | 2018-01-24 |
EP3783029A1 (en) | 2021-02-24 |
RS61152B1 (sr) | 2020-12-31 |
CN107667119A (zh) | 2018-02-06 |
HRP20201900T1 (hr) | 2021-01-22 |
HUE051815T2 (hu) | 2021-03-29 |
SI3294770T1 (sl) | 2021-01-29 |
JP2022078021A (ja) | 2022-05-24 |
MX2017014381A (es) | 2018-03-02 |
US20220073623A1 (en) | 2022-03-10 |
PT3294770T (pt) | 2020-12-04 |
LT3294770T (lt) | 2020-12-28 |
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