JP2017507900A5 - - Google Patents
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- JP2017507900A5 JP2017507900A5 JP2016539949A JP2016539949A JP2017507900A5 JP 2017507900 A5 JP2017507900 A5 JP 2017507900A5 JP 2016539949 A JP2016539949 A JP 2016539949A JP 2016539949 A JP2016539949 A JP 2016539949A JP 2017507900 A5 JP2017507900 A5 JP 2017507900A5
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Claims (24)
- ヒトPD−L1結合アンタゴニストを含む、個体において抗HER2抗体と組み合わせてがんを治療する又はその進行を遅延させるための、或いはがんを有する個体において抗HER2抗体と組み合わせて免疫機能を増強するための医薬であって、ヒトPD−L1結合アンタゴニストが抗PD−L1抗体である、医薬。
- PD−L1結合アンタゴニストが、PD−1へのPD−L1の結合を阻害するか、B7−1へのPD−L1の結合を阻害するか、或いはPD−1及びB7−1の両方へのPD−L1の結合を阻害する、請求項1に記載の医薬。
- PD−L1結合アンタゴニストが、MPDL3280A、MDX−1105及びMEDI4736からなる群から選択される、請求項1に記載の医薬。
- 抗PD−L1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;並びに配列番号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配列を含む軽鎖を含み、任意選択的に、配列番号25のアミノ酸配列を含む重鎖可変領域及び配列番号4のアミノ酸配列を含む軽鎖可変領域を含む、請求項1に記載の医薬。
- 抗HER2抗体が、トラスツズマブ又はペルツズマブである、請求項1から4の何れか一項に記載の医薬。
- 抗HER2抗体が、配列番号38のHVR−H1配列、配列番号50のHVR−H2配列及び配列番号40のHVR−H3配列を含む重鎖可変領域;並びに/又は配列番号41のHVR−L1配列、配列番号42のHVR−L2配列及び配列番号43のHVR−L3配列を含む軽鎖可変領域を含み、任意選択的に、配列番号34のアミノ酸配列を含む重鎖可変領域及び/又は配列番号35のアミノ酸配列を含む軽鎖可変領域含む、請求項1から4の何れか一項に記載の医薬。
- 抗HER2抗体が二重特異性抗体であり、
任意選択的に、二重特異性抗体が、HER2に結合する第1の抗原結合ドメイン及びCD3に結合する第2の抗原結合ドメインを含み;
任意選択的に、第1の抗原結合ドメインが、配列番号38のHVR−H1配列、配列番号50のHVR−H2配列及び配列番号40のHVR−H3配列を含む重鎖可変領域(V H HER2)並びに配列番号41のHVR−L1配列、配列番号42のHVR−L2配列及び配列番号43のHVR−L3配列を含む軽鎖可変領域(V L HER2)を含み;
任意選択的に、重鎖可変領域(V H HER2)が、配列番号34のアミノ酸配列を含み、及び軽鎖可変領域(V L HER2)が、配列番号35のアミノ酸配列を含み;
任意選択的に、第2の抗原結合ドメインが、ヒトCD3ポリペプチドに結合し;
任意選択的に、CD3ポリペプチドが、ヒトCD3εポリペプチド又はヒトCD3γポリペプチドであり;
任意選択的に、第2の抗原結合ドメインが、他のTCRサブユニットと会合した天然T細胞受容体(TCR)複合体中のヒトCD3εポリペプチド又はヒトCD3γポリペプチドに結合する、請求項1から4の何れか一項に記載の医薬。 - 二重特異性抗体が、第1の抗原結合ドメイン及び第2の抗原結合ドメインを含む単鎖二重特異性抗体であり;任意選択的に、単鎖二重特異性抗体が、N末端からC末端へと配置された、(1)V H HER2−V L HER2−V H CD3−V L CD3、(2)V H CD3−V L CD3−V H HER2−V L HER2、(3)V H CD3−V L CD3−V L HER2−V H HER2、(4)V H HER2−V L HER2−V L CD3−V H CD3、(5)V L HER2−V H HER2−V H CD3−V L CD3、又は(6)V L CD3−V H CD3−V H HER2−V L HER2からなる群から選択される可変領域を含む、請求項7に記載の医薬。
- (a)第1の抗原結合ドメインが、1又は複数の重鎖定常ドメインを含み、1又は複数の重鎖定常ドメインが、第1のCH1(CH11)ドメイン、第1のCH2(CH21)ドメイン、第1のCH3(CH31)ドメインから選択され、(b)第2の抗原結合ドメインが、1又は複数の重鎖定常ドメインを含み、1又は複数の重鎖定常ドメインが、第2のCH1(CH12)ドメイン、第2のCH2(CH22)ドメイン及び第2のCH3(CH32)ドメインから選択され;
任意選択的に、第1の抗原結合ドメインの1又は複数の重鎖定常ドメインのうち少なくとも1つが、第2の抗原結合ドメインの別の重鎖定常ドメインと対になっており;および
任意選択的に、CH3 1 及びCH3 2 ドメインが、各々、突出又は空洞を含み、CH3 1 ドメイン中の突出又は空洞が、それぞれ、CH3 2 ドメイン中の空洞又は突出において位置付け可能であり、CH3 1 及びCH3 2 ドメインが、任意選択的に、前記突出と空洞との間の接触面において接触するか;または
任意選択的に、CH2 1 及びCH2 2 ドメインが、各々、突出又は空洞を含み、CH2 1 ドメイン中の突出又は空洞が、それぞれ、CH2 2 ドメイン中の空洞又は突出において位置付け可能であり、CH2 1 及びCH2 2 ドメインが、前記突出と空洞との間の接触面において接触する、
請求項7に記載の医薬。 - 抗HER2抗体が、非グリコシル化部位突然変異を含み;
任意選択的に、非グリコシル化部位突然変異が置換突然変異であり;
任意選択的に、置換突然変異が、アミノ酸残基N297、L234、L235及び/又はD265(EU番号付け)にあり;
任意選択的に、置換突然変異が、N297G、N297A、L234A、L235A及びD265Aからなる群から選択され;
任意選択的に、置換突然変異が、D265A突然変異及びN297G突然変異であり;
非グリコシル化部位突然変異が、任意選択的に、抗HER2抗体のエフェクター機能を低減させる、
請求項1から9の何れか一項に記載の医薬。 - がんがHER2陽性がんであって、任意選択的に、がんが、乳がん、肺がん、卵巣がん、胃がん、膀胱がん、膵臓がん、子宮内膜がん、結腸がん、腎臓がん、食道がん又は前立腺がんである、請求項1から10のいずれか一項に記載の医薬。
- 個体中のがん細胞が、PD−L1を発現する、請求項1に記載の医薬。
- 個体が、HER2標的化療法に対して耐性又は難治性であるがんを有し、任意選択的に、HER2標的化療法が、抗HER2抗体又はHER2経路の阻害剤による治療であり、任意選択的に、HER2標的化療法が、トラスツズマブ、ペルツズマブ、アド−トラスツズマブエムタンシン又はラパチニブによる治療である、請求項1に記載の医薬。
- 抗HER2抗体が、PD−L1結合アンタゴニストの前に、PD−L1結合アンタゴニストと同時に、又はPD−L1結合アンタゴニストの後に投与される、請求項1から13の何れか一項に記載の医薬。
- PD−L1結合アンタゴニスト及び/又は抗HER2抗体が、静脈内、筋肉内、皮下、局所、経口、経皮、腹腔内、眼窩内、移植により、吸入により、髄腔内、脳室内又は鼻腔内投与される、請求項1から14の何れか一項に記載の医薬。
- さらに、がんを治療する又はその進行を遅延させるための化学療法剤を組み合わせる、請求項1から15の何れか一項に記載の医薬。
- 個体においてがんを治療する又はその進行を遅延させるための医薬の製造におけるヒトPD−L1結合アンタゴニストの使用であって、医薬は、ヒトPD−L1結合アンタゴニスト及び任意選択の薬学的に許容される担体を含み、治療は、抗HER2抗体及び任意選択の薬学的に許容される担体を含む組成物と組み合わせた医薬の投与を含み、ヒトPD−L1結合アンタゴニストが抗PD−L1抗体である、使用。
- 個体においてがんを治療する又はその進行を遅延させるための医薬の製造における抗HER2抗体の使用であって、医薬は、抗HER2抗体及び任意選択の薬学的に許容される担体を含み、治療は、ヒトPD−L1結合アンタゴニスト及び任意選択の薬学的に許容される担体を含む組成物と組み合わせた医薬の投与を含み、ヒトPD−L1結合アンタゴニストが抗PD−L1抗体である、使用。
- 個体においてがんを治療する又はその進行を遅延させる際の使用のための、ヒトPD−L1結合アンタゴニスト及び任意選択の薬学的に許容される担体を含む組成物であって、治療は、第2の組成物と組み合わせた前記組成物の投与を含み、第2の組成物は、抗HER2抗体及び任意選択の薬学的に許容される担体を含み、ヒトPD−L1結合アンタゴニストが抗PD−L1抗体である、組成物。
- 個体においてがんを治療する又はその進行を遅延させる際の使用のための、抗HER2抗体及び任意選択の薬学的に許容される担体を含む組成物であって、治療は、第2の組成物と組み合わせた前記組成物の投与を含み、第2の組成物は、ヒトPD−L1結合アンタゴニスト及び任意選択の薬学的に許容される担体を含み、ヒトPD−L1結合アンタゴニストが抗PD−L1抗体である、組成物。
- PD−L1結合アンタゴニスト及び任意選択の薬学的に許容される担体を含む医薬、並びに個体においてがんを治療する又はその進行を遅延させるための、抗HER2抗体及び任意選択の薬学的に許容される担体を含む組成物と組み合わせた医薬の投与についての説明書を含む添付文書を含み、ヒトPD−L1結合アンタゴニストが抗PD−L1抗体である、キット。
- PD−L1結合アンタゴニスト及び任意選択の薬学的に許容される担体を含む第1の医薬、並びに抗HER2抗体及び任意選択の薬学的に許容される担体を含む第2の医薬を含み、ヒトPD−L1結合アンタゴニストが抗PD−L1抗体である、キット。
- 個体においてがんを治療する又はその進行を遅延させるための第1の医薬及び第2の医薬の投与についての説明書を含む添付文書をさらに含む、請求項22に記載のキット。
- 抗HER2抗体及び任意選択の薬学的に許容される担体を含む医薬、並びに個体においてがんを治療する又はその進行を遅延させるための、PD−L1結合アンタゴニスト及び任意選択の薬学的に許容される担体を含む組成物と組み合わせた医薬の投与についての説明書を含む添付文書を含み、ヒトPD−L1結合アンタゴニストが抗PD−L1抗体である、キット。
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US201361917264P | 2013-12-17 | 2013-12-17 | |
US61/917,264 | 2013-12-17 | ||
PCT/US2014/070992 WO2015095418A1 (en) | 2013-12-17 | 2014-12-17 | Methods of treating her2-positive cancers using pd-1 axis binding antagonists and anti-her2 antibodies |
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US (9) | US10570213B2 (ja) |
EP (4) | EP3647324A1 (ja) |
JP (5) | JP6841656B2 (ja) |
KR (4) | KR20160089531A (ja) |
CN (3) | CN105828837B (ja) |
AU (3) | AU2014364587B9 (ja) |
BR (1) | BR112016013896A2 (ja) |
CA (2) | CA2931812A1 (ja) |
DK (1) | DK3083686T4 (ja) |
ES (1) | ES2763429T5 (ja) |
FI (1) | FI3083686T4 (ja) |
HK (1) | HK1225634A1 (ja) |
HR (1) | HRP20192288T4 (ja) |
HU (1) | HUE047699T2 (ja) |
IL (3) | IL296657A (ja) |
LT (1) | LT3083686T (ja) |
MX (3) | MX2016007887A (ja) |
MY (1) | MY189089A (ja) |
NZ (2) | NZ720515A (ja) |
PL (1) | PL3083686T5 (ja) |
PT (1) | PT3083686T (ja) |
RS (1) | RS59659B2 (ja) |
RU (1) | RU2719487C2 (ja) |
SG (4) | SG11201604956SA (ja) |
SI (1) | SI3083686T2 (ja) |
WO (2) | WO2015095404A2 (ja) |
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