JPWO2020176748A5 - - Google Patents

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JPWO2020176748A5
JPWO2020176748A5 JP2021549760A JP2021549760A JPWO2020176748A5 JP WO2020176748 A5 JPWO2020176748 A5 JP WO2020176748A5 JP 2021549760 A JP2021549760 A JP 2021549760A JP 2021549760 A JP2021549760 A JP 2021549760A JP WO2020176748 A5 JPWO2020176748 A5 JP WO2020176748A5
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antibody
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tigit antagonist
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Priority claimed from PCT/US2020/020135 external-priority patent/WO2020176748A1/en
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血液がんを有する対象を処置するための、抗ＴＩＧＩＴアンタゴニスト抗体を含む医薬であって、前記医薬が、抗ＣＤ３８抗体との組合せで、同時に又は別個に投与され、少なくとも９回の投薬サイクルを含む投薬レジメンにおいて、前記抗ＴＩＧＩＴアンタゴニスト抗体が、約３０ｍｇ～約１２００ｍｇの固定用量で投与され、且つ前記抗ＣＤ３８抗体が、約８ｍｇ／ｋｇ～約２４ｍｇ／ｋｇの用量で投与され、
（ａ）前記抗ＴＩＧＩＴアンタゴニスト抗体が３週間ごとに１回投与され、
（ｂ）前記抗ＣＤ３８抗体が、投薬サイクル１～３のそれぞれの間に１週間ごとに１回、投薬サイクル４～８のそれぞれの間に３週間ごとに１回、及び投薬サイクル９からは４週間ごとに１回投与される、医薬。 A medicament comprising an anti-TIGIT antagonist antibody for treating a subject with a hematological cancer , said medicament being administered simultaneously or separately in combination with an anti-CD38 antibody and comprising at least 9 dosing cycles in a dosing regimen, said anti-TIGIT antagonist antibody is administered at a fixed dose of about 30 mg to about 1200 mg and said anti-CD38 antibody is administered at a dose of about 8 mg/kg to about 24 mg/kg;
(a) the anti-TIGIT antagonist antibody is administered once every three weeks;
(b) the anti-CD38 antibody once every week during each of dosing cycles 1-3, once every three weeks during each of dosing cycles 4-8, and 4 times from dosing cycles 9-8; A medicament administered once per week. 血液がんを有する対象を処置するための、抗ＣＤ３８抗体を含む医薬であって、前記医薬が、抗ＴＩＧＩＴアンタゴニスト抗体との組合せで、同時に又は別個に投与され、少なくとも９回の投薬サイクルを含む投薬レジメンにおいて、前記抗ＴＩＧＩＴアンタゴニスト抗体が、約３０ｍｇ～約１２００ｍｇの固定用量で投与され、且つ前記抗ＣＤ３８抗体が、約８ｍｇ／ｋｇ～約２４ｍｇ／ｋｇの用量で投与され、 A medicament comprising an anti-CD38 antibody for treating a subject with a hematologic cancer, said medicament being administered simultaneously or separately in combination with an anti-TIGIT antagonist antibody and comprising at least 9 dosing cycles in a dosing regimen, said anti-TIGIT antagonist antibody is administered at a fixed dose of about 30 mg to about 1200 mg and said anti-CD38 antibody is administered at a dose of about 8 mg/kg to about 24 mg/kg;
（ａ）前記抗ＴＩＧＩＴアンタゴニスト抗体が３週間ごとに１回投与され、 (a) the anti-TIGIT antagonist antibody is administered once every three weeks;
（ｂ）前記抗ＣＤ３８抗体が、投薬サイクル１～３のそれぞれの間に１週間ごとに１回、投薬サイクル４～８のそれぞれの間に３週間ごとに１回、及び投薬サイクル９からは４週間ごとに１回投与される、医薬。 (b) the anti-CD38 antibody once every week during each of dosing cycles 1-3, once every three weeks during each of dosing cycles 4-8, and 4 times from dosing cycles 9-8; A medicament that is administered once every week. 血液がんを有する対象を処置するための、抗ＴＩＧＩＴアンタゴニスト抗体及び抗ＣＤ３８抗体を含む医薬であって、少なくとも９回の投薬サイクルを含む投薬レジメンにおいて、前記抗ＴＩＧＩＴアンタゴニスト抗体が、約３０ｍｇ～約１２００ｍｇの固定用量で投与され、且つ前記抗ＣＤ３８抗体が、約８ｍｇ／ｋｇ～約２４ｍｇ／ｋｇの用量で投与され、 A medicament comprising an anti-TIGIT antagonist antibody and an anti-CD38 antibody for treating a subject with a hematologic cancer, wherein the anti-TIGIT antagonist antibody is from about 30 mg to about administered at a fixed dose of 1200 mg, and said anti-CD38 antibody is administered at a dose of about 8 mg/kg to about 24 mg/kg;
（ａ）前記抗ＴＩＧＩＴアンタゴニスト抗体が３週間ごとに１回投与され、 (a) the anti-TIGIT antagonist antibody is administered once every three weeks;
（ｂ）前記抗ＣＤ３８抗体が、投薬サイクル１～３のそれぞれの間に１週間ごとに１回、投薬サイクル４～８のそれぞれの間に３週間ごとに１回、及び投薬サイクル９からは４週間ごとに１回投与される、医薬。 (b) the anti-CD38 antibody once every week during each of dosing cycles 1-3, once every three weeks during each of dosing cycles 4-8, and 4 times from dosing cycles 9-8; A medicament that is administered once every week. 各投薬サイクルの長さが２１日間である、請求項１～３のいずれか一項に記載の医薬。 A medicament according to any one of claims 1 to 3 , wherein the length of each dosing cycle is 21 days. （ａ）前記抗ＴＩＧＩＴアンタゴニスト抗体が、各投薬サイクルの１日目又はその前後に投与される、且つ／又は
（ｂ）前記抗ＣＤ３８抗体が、投薬サイクル１～３のそれぞれの１日目、８日目及び１５日目又はそれらの前後、投薬サイクル４～８のそれぞれの１日目又はその前後、並びに投薬サイクル９の１日目又はその前後に投与される、
請求項１～４のいずれか一項に記載の医薬。 ( a) the anti-TIGIT antagonist antibody is administered on or before or after Day 1 of each dosing cycle, and/or
(b) the anti-CD38 antibody is administered on or before each of Days 1, 8 and 15 of dosing cycles 1-3, on or before Day 1 of each of dosing cycles 4-8, and dosing; administered on or before or after Day 1 of Cycle 9;
The medicament according to any one of claims 1-4 . 前記抗ＴＩＧＩＴアンタゴニスト抗体及び前記抗ＣＤ３８抗体の両方が、投薬サイクル１～９のそれぞれの１日目又はその前後に投与され、前記抗ＴＩＧＩＴアンタゴニスト抗体が、前記抗ＣＤ３８抗体の前に投与される、請求項１～５のいずれか一項に記載の医薬。 both the anti-TIGIT antagonist antibody and the anti-CD38 antibody are administered on or around Day 1 of each of dosing cycles 1-9 , and the anti-TIGIT antagonist antibody is administered before the anti-CD38 antibody ; The medicament according to any one of claims 1-5 . 前記投薬レジメンが少なくとも１２回の投薬サイクル又は少なくとも１６回の投薬サイクルを含む、請求項１～６のいずれか一項に記載の医薬。 A medicament according to any one of claims 1 to 6 , wherein said dosing regimen comprises at least 12 dosing cycles or at least 16 dosing cycles . （ａ）コルチコステロイド、解熱剤及び／又は抗ヒスタミン剤が、前記抗ＣＤ３８抗体の各投与の前に前記対象に投与される；且つ／又は
（ｂ）コルチコステロイドが、前記抗ＣＤ３８抗体の投与後２日間のそれぞれの日に前記対象に投与される、
請求項１～７のいずれか一項に記載の医薬。 ( a) a corticosteroid, antipyretic and /or antihistamine is administered to said subject prior to each administration of said anti-CD38 antibody ; and/or
(b) a corticosteroid is administered to the subject on each of the two days following administration of the anti-CD38 antibody ;
The medicament according to any one of claims 1-7 . 前記抗ＣＤ３８抗体が、約１６ｍｇ／ｋｇの用量で投与される、請求項１～８のいずれか一項に記載の医薬。 A medicament according to any one of claims 1 to 8 , wherein said anti-CD38 antibody is administered at a dose of about 16 mg/kg. 前記抗ＣＤ３８抗体が抗ＣＤ３８アンタゴニスト抗体である、請求項１～９のいずれか一項に記載の医薬。 The medicament according to any one of claims 1 to 9 , wherein said anti-CD38 antibody is an anti-CD38 antagonist antibody. 前記抗ＣＤ３８抗体が、以下の相補性決定領域（ＣＤＲ）を含む、請求項１～１０のいずれか一項に記載の医薬：
（ａ）ＳＦＡＭＳ（配列番号２０）のアミノ酸配列を含むＣＤＲ－Ｈ１；
（ｂ）ＡＩＳＧＳＧＧＧＴＹＹＡＤＳＶＫＧ（配列番号２１）のアミノ酸配列を含むＣＤＲ－Ｈ２；
（ｃ）ＤＫＩＬＷＦＧＥＰＶＦＤＹ（配列番号２２）のアミノ酸配列を含むＣＤＲ－Ｈ３；
（ｄ）ＲＡＳＱＳＶＳＳＹＬＡ（配列番号２３）のアミノ酸配列を含むＣＤＲ－Ｌ１；
（ｅ）ＤＡＳＮＲＡＴ（配列番号２４）のアミノ酸配列を含むＣＤＲ－Ｌ２；及び
（ｆ）ＱＱＲＳＮＷＰＰＴＦ（配列番号２５）のアミノ酸配列を含むＣＤＲ－Ｌ３。 The medicament according to any one of claims 1 to 10 , wherein said anti-CD38 antibody comprises the following complementarity determining regions (CDRs):
(a) a CDR-H1 comprising the amino acid sequence of SFAMS (SEQ ID NO: 20);
(b) a CDR-H2 comprising the amino acid sequence of AISGSGGGTYYADSVKG (SEQ ID NO: 21);
(c) a CDR-H3 comprising the amino acid sequence of DKILWFGEPVFDY (SEQ ID NO:22);
(d) a CDR-L1 comprising the amino acid sequence of RASQSVSSYLA (SEQ ID NO:23);
(e) CDR-L2 comprising the amino acid sequence of DASNRAT (SEQ ID NO:24); and (f) CDR-L3 comprising the amino acid sequence of QQRSNWPPTF (SEQ ID NO:25). 前記抗ＣＤ３８抗体が：
（ａ）ＥＶＱＬＬＥＳＧＧＧＬＶＱＰＧＧＳＬＲＬＳＣＡＶＳＧＦＴＦＮＳＦＡＭＳＷＶＲＱＡＰＧＫＧＬＥＷＶＳＡＩＳＧＳＧＧＧＴＹＹＡＤＳＶＫＧ ＲＦＴＩＳＲＤＮＳＫＮＴＬＹＬＱＭＮＳＬＲＡＥＤＴＡＶＹＦＣＡＫＤＫＩＬＷＦＧＥＰＶＦＤＹＷＧＱＧＴＬＶＴＶＳＳ（配列番号３４）のアミノ酸配列と少なくとも９５％の配列同一性を有するアミノ酸配列を含む重鎖可変（ＶＨ）ドメイン；
（ｂ）ＥＩＶＬＴＱＳＰＡＴＬＳＬＳＰＧＥＲＡＴＬＳＣＲＡＳＱＳＶＳＳＹＬＡＷＹＱＱＫＰＧＱＡＰＲＬＬＩＹＤＡＳＮＲＡＴＧ ＩＰＡＲＦＳＧＳＧＳＧＴＤＦＴＬＴＩＳＳＬＥＰＥＤＦＡＶＹＹＣＱＱＲＳＮＷＰＰＴＦＧＱＧＴＫＶＥＩＫ（配列番号３５）のアミノ酸配列と少なくとも９５％の配列同一性を有するアミノ酸配列を含む軽鎖可変（ＶＬ）ドメイン；又は
（ｃ）（ａ）と同様のＶＨドメイン及び（ｂ）と同様のＶＬドメイン
を更に含む、請求項１１に記載の医薬。 wherein said anti-CD38 antibody:
(a) a variable heavy chain (HV) sequence having at least 95% sequence identity to the amino acid sequence of EVQLLESGGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYYADSVKG RFTISRDNSKNTLYLQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTVSS (SEQ ID NO: 34);
(b) a light chain variable (VL) domain (VL) domain comprising an amino acid sequence having at least 95% sequence identity with the amino acid sequence of EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATG IPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPTFGQGTKVEIK (SEQ ID NO: 35) and a bVHa (VL) domain similar to that of the light chain; 12. The medicament according to claim 11 , further comprising a VL domain similar to ). 前記抗ＣＤ３８抗体が、以下を含む、請求項１２に記載の医薬。
（ａ）配列番号３４のアミノ酸配列を含むＶＨドメイン；及び
（ｂ）配列番号３５のアミノ酸配列を含むＶＬドメイン。 13. A medicament according to claim 12 , wherein said anti-CD38 antibody comprises:
(a) a VH domain comprising the amino acid sequence of SEQ ID NO:34; and (b) a VL domain comprising the amino acid sequence of SEQ ID NO:35. 前記抗ＣＤ３８抗体が、モノクローナル抗体、ヒト抗体、及び／又は完全長抗体である、請求項１～１３のいずれか一項に記載の医薬。 The medicament according to any one of claims 1 to 13 , wherein said anti-CD38 antibody is a monoclonal antibody , a human antibody and/or a full-length antibody . 前記抗ＣＤ３８抗体が、ダラツムマブである、請求項１～１４のいずれか一項に記載の医薬。 The medicament according to any one of claims 1 to 14 , wherein said anti-CD38 antibody is daratumumab. 前記抗ＣＤ３８抗体が、Ｆａｂ、Ｆａｂ’、Ｆａｂ’－ＳＨ、Ｆｖ、一本鎖可変断片（ｓｃＦｖ）、及び（Ｆａｂ’）２断片からなる群から選択されるＣＤ３８に結合する抗体断片である、請求項１～１３のいずれか一項に記載の医薬。 wherein said anti-CD38 antibody is an antibody fragment that binds to CD38 selected from the group consisting of Fab, Fab', Fab'-SH, Fv, single-chain variable fragment (scFv), and (Fab') 2 fragment; The medicament according to any one of claims 1-13 . 前記抗ＣＤ３８抗体がＩｇＧクラス抗体又はＩｇＧ１サブクラス抗体である、請求項１～１５のいずれか一項に記載の医薬。 The medicament according to any one of claims 1 to 15 , wherein said anti-CD38 antibody is an IgG class antibody or an IgG1 subclass antibody . 前記抗ＣＤ３８抗体が、前記対象に静脈内投与される、請求項１～１７のいずれか一項に記載の医薬。 The medicament according to any one of claims 1 to 17 , wherein said anti-CD38 antibody is administered intravenously to said subject. 前記血液がんが骨髄腫、多発性骨髄腫（ＭＭ）、又は再発性若しくは難治性のＭＭである、請求項１～１８のいずれか一項に記載の医薬。 The medicament according to any one of claims 1 to 18 , wherein said hematologic cancer is myeloma , multiple myeloma (MM), or relapsed or refractory MM . 血液がんを有する対象を処置するための、抗ＴＩＧＩＴアンタゴニスト抗体を含む医薬であって、前記医薬が、抗ＣＤ２０抗体との組合せで、同時に又は別個に投与され、少なくとも第１、第２及び第３の投薬サイクルを含む投薬レジメンにおいて、前記抗ＴＩＧＩＴアンタゴニスト抗体が、約３０ｍｇ～約１２００ｍｇの固定用量で投与され、且つ前記抗ＣＤ２０抗体が、約２５０ｍｇ／ｍ２～約５００ｍｇ／ｍ２の用量で投与され、
（ａ）前記抗ＴＩＧＩＴアンタゴニスト抗体が、３週間ごとに１回投与され、
（ｂ）前記抗ＣＤ２０抗体が、１週間ごとに１回投与される、医薬。 A medicament comprising an anti-TIGIT antagonist antibody for treating a subject with a hematological cancer, said medicament being administered in combination with an anti-CD20 antibody, simultaneously or separately, and comprising at least a first, second and second In a dosing regimen comprising 3 dosing cycles, said anti-TIGIT antagonist antibody is administered at a fixed dose of about 30 mg to about 1200 mg and said anti-CD20 antibody is administered at a dose of about 250 mg/m 2 to about 500 mg/m 2 . administered ,
(a) said anti-TIGIT antagonist antibody is administered once every three weeks;
(b) A medicament , wherein said anti-CD20 antibody is administered once every week. 血液がんを有する対象を処置するための、抗ＣＤ２０抗体を含む医薬であって、前記医薬が、抗ＴＩＧＩＴアンタゴニスト抗体との組合せで、同時に又は別個に投与され、少なくとも第１、第２及び第３の投薬サイクルを含む投薬レジメンにおいて、前記抗ＴＩＧＩＴアンタゴニスト抗体が、約３０ｍｇ～約１２００ｍｇの固定用量で投与され、且つ前記抗ＣＤ２０抗体が、約２５０ｍｇ／ｍ ２ ～約５００ｍｇ／ｍ ２ の用量で投与され、
（ａ）前記抗ＴＩＧＩＴアンタゴニスト抗体が、３週間ごとに１回投与され、
（ｂ）前記抗ＣＤ２０抗体が、１週間ごとに１回投与される、医薬。 A medicament comprising an anti-CD20 antibody for treating a subject with a hematological cancer, said medicament being administered simultaneously or separately in combination with an anti-TIGIT antagonist antibody, wherein at least a first, second and second In a dosing regimen comprising 3 dosing cycles, said anti-TIGIT antagonist antibody is administered at a fixed dose of about 30 mg to about 1200 mg and said anti-CD20 antibody is administered at a dose of about 250 mg/m 2 to about 500 mg / m 2 . administered,
(a) the anti-TIGIT antagonist antibody is administered once every three weeks;
(b) A medicament, wherein said anti-CD20 antibody is administered once every week. 血液がんを有する対象を処置するための、抗ＴＩＧＩＴアンタゴニスト抗体及び抗ＣＤ２０抗体を含む医薬であって、少なくとも第１、第２及び第３の投薬サイクルを含む投薬レジメンにおいて、前記抗ＴＩＧＩＴアンタゴニスト抗体が、約３０ｍｇ～約１２００ｍｇの固定用量で投与され、且つ前記抗ＣＤ２０抗体が、約２５０ｍｇ／ｍ A medicament comprising an anti-TIGIT antagonist antibody and an anti-CD20 antibody for treating a subject with a hematologic cancer, wherein said anti-TIGIT antagonist antibody is administered in a dosing regimen comprising at least first, second and third dosing cycles is administered at a fixed dose of about 30 mg to about 1200 mg, and the anti-CD20 antibody is about 250 mg/m ２2 ～約５００ｍｇ／ｍ~ about 500mg/m ２2 の用量で投与され、administered at a dose of
（ａ）前記抗ＴＩＧＩＴアンタゴニスト抗体が、３週間ごとに１回投与され、 (a) the anti-TIGIT antagonist antibody is administered once every three weeks;
（ｂ）前記抗ＣＤ２０抗体が、１週間ごとに１回投与される、医薬。 (b) A medicament, wherein said anti-CD20 antibody is administered once every week. （ａ）前記投薬レジメンの各投薬サイクルが、単回用量の前記抗ＴＩＧＩＴアンタゴニスト抗体を含み、
（ｂ）前記第１の投薬サイクルが、前記抗ＣＤ２０抗体の第１の用量（Ｃ１Ｄ１）、第２の用量（Ｃ１Ｄ２）及び第３の用量（Ｃ１Ｄ３）を含み、
（ｃ）前記第２の投薬サイクルが、前記抗ＣＤ２０抗体の第１の用量（Ｃ２Ｄ１）、第２の用量（Ｃ２Ｄ２）及び第３の用量（Ｃ２Ｄ３）を含み、
（ｄ）前記第３の投薬サイクルが、前記抗ＣＤ２０抗体の少なくとも第１の用量（Ｃ３Ｄ１）及び第２の用量（Ｃ３Ｄ２）を含む、請求項２０～２２のいずれか一項に記載の医薬。 (a) each dosing cycle of said dosing regimen comprises a single dose of said anti-TIGIT antagonist antibody;
(b) said first dosing cycle comprises a first dose (C1D1), a second dose (C1D2) and a third dose (C1D3) of said anti-CD20 antibody;
(c) said second dosing cycle comprises a first dose (C2D1), a second dose (C2D2) and a third dose (C2D3) of said anti-CD20 antibody;
(d) said third dosing cycle comprises at least a first dose (C3D1) and a second dose ( C3D2 ) of said anti - CD20 antibody. 前記投薬レジメンが合計８用量の前記抗ＣＤ２０抗体を含む、請求項２０～２３のいずれか一項に記載の医薬。 A medicament according to any one of claims 20 to 23 , wherein said dosing regimen comprises a total of 8 doses of said anti-CD20 antibody. 各投薬サイクルの長さが２１日間である、請求項２０～２４のいずれか一項に記載の医薬。 A medicament according to any one of claims 20 to 24 , wherein the length of each dosing cycle is 21 days. （ａ）前記抗ＴＩＧＩＴアンタゴニスト抗体が、各投薬サイクルの１日目又はその前後に前記対象に投与される：
（ｂ）前記抗ＣＤ２０抗体の前記Ｃ１Ｄ１、前記Ｃ１Ｄ２及び前記Ｃ１Ｄ３が、前記第１の投薬サイクルのそれぞれ１日目、８日目及び１５日目、又はそれらの前後に前記対象に投与される；
（ｃ）前記抗ＣＤ２０抗体の前記Ｃ２Ｄ１、前記Ｃ２Ｄ２及び前記Ｃ２Ｄ３が、前記第２の投薬サイクルのそれぞれ１日目、８日目及び１５日目、又はそれらの前後に前記対象に投与される：且つ／又は
（ｄ）前記抗ＣＤ２０抗体の前記Ｃ３Ｄ１及び前記Ｃ３Ｄ２が、前記第３の投薬サイクルのそれぞれ１日目及び８日目、又はそれらの前後に前記対象に投与される、
請求項２０～２５のいずれか一項に記載の医薬。 (a) the anti-TIGIT antagonist antibody is administered to the subject on or before or after Day 1 of each dosing cycle :
(b) said C1D1, said C1D2 and said C1D3 of said anti-CD20 antibody are administered to said subject on or before or after Days 1, 8 and 15, respectively, of said first dosing cycle;
(c) said anti-CD20 antibody C2D1, said C2D2 and said C2D3 are administered to said subject on, or before or after, days 1, 8 and 15, respectively, of said second dosing cycle: and/or
(d) said anti-CD20 antibody C3D1 and said C3D2 are administered to said subject on, or before or after, days 1 and 8, respectively, of said third dosing cycle;
The medicament according to any one of claims 20-25 . 前記抗ＴＩＧＩＴアンタゴニスト抗体及び前記抗ＣＤ２０抗体の両方が、投薬サイクル１、２及び３のそれぞれの１日目又はその前後に投与され、前記抗ＴＩＧＩＴアンタゴニスト抗体が、前記抗ＣＤ２０抗体の前に投与される、請求項２０～２６のいずれか一項に記載の医薬。 Both the anti-TIGIT antagonist antibody and the anti-CD20 antibody are administered on or before or after Day 1 of each of dosing cycles 1, 2 and 3 , and the anti-TIGIT antagonist antibody is administered before the anti-CD20 antibody. The medicament according to any one of claims 20 to 26 . 前記投薬レジメンが少なくとも１２回の投薬サイクル又は少なくとも１６回の投薬サイクルを含む、請求項２０～２７のいずれか一項に記載の医薬。 A medicament according to any one of claims 20 to 27 , wherein said dosing regimen comprises at least 12 dosing cycles or at least 16 dosing cycles . 前記対象が、抗ＴＩＧＩＴアンタゴニスト抗体に対する注入関連反応（ＩＲＲ）を有し、抗ヒスタミン剤及び／又は解熱剤が、前記抗ＴＩＧＩＴアンタゴニスト抗体のその後の投与の前に、前記対象に投与される、請求項２０～２８のいずれか一項に記載の医薬。 10. The subject has an infusion-related reaction (IRR) to an anti-TIGIT antagonist antibody , and an antihistamine and/or antipyretic is administered to the subject prior to subsequent administration of the anti-TIGIT antagonist antibody. 29. The medicament according to any one of 20-28 . 前記抗ＣＤ２０抗体の各投与の前に、解熱剤及び抗ヒスタミン剤が、前記対象に投与される、且つ／又はグルココルチコイドが、前記対象に投与される、請求項２０～２９のいずれか一項に記載の医薬。 30. Any one of claims 20-29 , wherein an antipyretic and an antihistamine are administered to the subject and/or a glucocorticoid is administered to the subject prior to each administration of the anti-CD20 antibody. Medicine . 前記抗ＣＤ２０抗体が、約３７５ｍｇ／ｍ２の用量で前記対象に投与される、請求項２０～３０のいずれか一項に記載の医薬。 The medicament according to any one of claims 20-30 , wherein said anti-CD20 antibody is administered to said subject at a dose of about 375 mg/m 2 . 前記抗ＣＤ２０抗体が、抗ＣＤ２０アンタゴニスト抗体である、請求項２０～３１のいずれか一項に記載の医薬。 The medicament according to any one of claims 20 to 31 , wherein said anti-CD20 antibody is an anti-CD20 antagonist antibody. 前記抗ＣＤ２０アンタゴニスト抗体が、以下のＣＤＲを含む、請求項２０～３２のいずれか一項に記載の医薬：
（ａ）ＳＹＮＭＨ（配列番号３６）のアミノ酸配列を含むＣＤＲ－Ｈ１；
（ｂ）ＡＩＹＰＧＮＧ ＤＴＳＹＮＱＫＦＫＧ（配列番号３７）のアミノ酸配列を含むＣＤＲ－Ｈ２；
（ｃ）ＳＴＹＹＧＧ ＤＷＹＦＮＶ（配列番号３８）のアミノ酸配列を含むＣＤＲ－Ｈ３；
（ｄ）ＲＡＳＳＳＶＳＹＩＨ（配列番号３９）のアミノ酸配列を含むＣＤＲ－Ｌ１；
（ｅ）ＡＴＳＮＬＡＳ（配列番号４０）のアミノ酸配列を含むＣＤＲ－Ｌ２；及び
（ｆ）ＱＱＷＴＳＮＰＰＴ（配列番号４１）のアミノ酸配列を含むＣＤＲ－Ｌ３。 The medicament according to any one of claims 20 to 32 , wherein said anti-CD20 antagonist antibody comprises the following CDRs:
(a) a CDR-H1 comprising the amino acid sequence of SYNMH (SEQ ID NO:36);
(b) a CDR-H2 comprising the amino acid sequence of AIYPGNG DTSYNQKFKG (SEQ ID NO:37);
(c) a CDR-H3 comprising the amino acid sequence of STYYGG DWYFNV (SEQ ID NO:38);
(d) a CDR-L1 comprising the amino acid sequence of RASSSVSYIH (SEQ ID NO:39);
(e) CDR-L2 comprising the amino acid sequence of ATSNLAS (SEQ ID NO:40); and (f) CDR-L3 comprising the amino acid sequence of QQWTSNPPT (SEQ ID NO:41). 前記抗ＣＤ２０抗体が：
（ａ）ＱＶＱＬＱＱＰＧＡＥＬＶＫＰＧＡＳＶＫＭＳＣＫＡＳＧＹＴＦＴＳＹＮＭＨＷＶＫＱＴＰＧ ＲＧＬＥＷＩＧＡＩＹＰＧＮＧＤＴＳＹＮＱＫＦＫＧＫＡＴＬＴＡＤＫＳＳＳＴＡＹＭＱＬＳＳＬＴＳＥＤＳＡＶＹＹＣＡＲＳＴＹＹＧＧＤＷＹＦＮＶＷＧＡＧＴＴＶＴＶＳ（配列番号５０）のアミノ酸配列と少なくとも９５％の配列同一性を有するアミノ酸配列を含むＶＨドメイン；
（ｂ）ＱＩＶＬＳＱＳＰＡＩＬＳＡＳＰＧＥＫＶＴＭＴＣＲＡＳＳＳＶＳＹＩＨＷＦＱＱＫＰＧＳＳＰＫＰＷＩＹＡＴＳＮＬＡＳＧＶＰＶＲＦＳＧＳＧＳＧＴＳＹＳＬＴＩＳＲＶＥＡＥＤＡＡＴＹＹＣＱＱＷＴＳＮＰＰＴＦＧＧＧＴＫＬＥＩＫ（配列番号５１）のアミノ酸配列と少なくとも９５％の配列同一性を有するアミノ酸配列を含むＶＬドメイン；又は
（ｃ）（ａ）と同様のＶＨドメイン及び（ｂ）と同様のＶＬドメイン
を更に含む、請求項３３に記載の医薬。 wherein said anti-CD20 antibody:
(a) a VH domain having at least 95% sequence identity with the amino acid sequence of QVQLQQPGAELVKPGASVKMSCKASGYTFTSYNMHWVKQTPG RGLEWIGAIYPGNGDTSYNQKFKGKATLTADKSSSTAYMQLSSLTSEDSAVYYCARSTYYGGDWYFNVWGAGTTVTVS (SEQ ID NO: 50);
(b) a VL domain comprising an amino acid sequence having at least 95% sequence identity with the amino acid sequence of QIVLSQSPAILSASPGEKVTMTCRASSSVSYIHWFQQKPGSSPKPWIYATSNLASGVPVRFSGSGSGTSYSLTISRVEAEDAATYYCQQWTSNPPTFGGGTKLEIK (SEQ ID NO: 51); 34. The medicament of claim 33 , further comprising 前記抗ＣＤ２０抗体が、以下を含む、請求項３４に記載の医薬：
（ａ）配列番号５０のアミノ酸配列を含むＶＨドメイン；及び
（ｂ）配列番号５１のアミノ酸配列を含むＶＬドメイン。 35. The medicament of claim 34 , wherein said anti-CD20 antibody comprises:
(a) a VH domain comprising the amino acid sequence of SEQ ID NO:50; and (b) a VL domain comprising the amino acid sequence of SEQ ID NO:51. 前記抗ＣＤ２０抗体が、モノクローナル抗体、キメラ抗体、及び／又は完全長抗体である、請求項２０～３５のいずれか一項に記載の医薬。 A medicament according to any one of claims 20 to 35 , wherein said anti-CD20 antibody is a monoclonal antibody , a chimeric antibody and/or a full-length antibody . 前記抗ＣＤ２０抗体が、リツキシマブである、請求項２０～３６のいずれか一項に記載の医薬。 The medicament according to any one of claims 20 to 36 , wherein said anti-CD20 antibody is rituximab. 前記抗ＣＤ２０抗体が、Ｆａｂ、Ｆａｂ’、Ｆａｂ’－ＳＨ、Ｆｖ、一本鎖可変断片（ｓｃＦｖ）、及び（Ｆａｂ’）２断片からなる群から選択されるＣＤ２０に結合する抗体断片である、請求項２０～３５のいずれか一項に記載の医薬。 wherein the anti-CD20 antibody is an antibody fragment that binds to CD20 selected from the group consisting of Fab, Fab', Fab'-SH, Fv, single-chain variable fragment (scFv), and (Fab') 2 fragment; The medicament according to any one of claims 20-35 . 前記抗ＣＤ２０抗体がＩｇＧクラス抗体又はＩｇＧ１サブクラス抗体である、請求項２０～３７のいずれか一項に記載の医薬。 The medicament according to any one of claims 20 to 37 , wherein said anti-CD20 antibody is an IgG class antibody or an IgG1 subclass antibody . 前記抗ＣＤ２０抗体が、前記対象に静脈内投与される、請求項２０～３９のいずれか一項に記載の医薬。 The medicament according to any one of claims 20 to 39 , wherein said anti-CD20 antibody is administered intravenously to said subject. 前記血液がんがリンパ腫、非ホジキンリンパ腫（ＮＨＬ）、再発性若しくは難治性のびまん性大細胞型Ｂ細胞リンパ腫（ＤＬＢＣＬ）、又は再発性若しくは難治性の濾胞性リンパ腫（ＦＬ）である、請求項２０～４０のいずれか一項に記載の医薬。 4. The hematological cancer is lymphoma, non-Hodgkin's lymphoma (NHL), relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or relapsed or refractory follicular lymphoma (FL). The medicament according to any one of 20 to 40 . 前記抗ＴＩＧＩＴアンタゴニスト抗体が、約３０ｍｇ～約６００ｍｇの固定用量で前記対象に投与される、請求項１～４１のいずれか一項に記載の医薬。 42. The medicament of any one of claims 1-41 , wherein the anti-TIGIT antagonist antibody is administered to the subject at a fixed dose of about 30 mg to about 600 mg. 前記抗ＴＩＧＩＴアンタゴニスト抗体が、約６００ｍｇの固定用量で投与される、請求項４２に記載の医薬。 43. The medicament of Claim 42 , wherein said anti- TIGIT antagonist antibody is administered at a fixed dose of about 600 mg. 前記抗ＴＩＧＩＴアンタゴニスト抗体が、以下のＣＤＲを含む、請求項１～４３のいずれか一項に記載の医薬：
（ａ）ＳＮＳＡＡＷＮ（配列番号１）のアミノ酸配列を含むＣＤＲ－Ｈ１；
（ｂ）ＫＴＹＹＲＦＫＷＹＳＤＹＡＶＳＶＫＧ（配列番号２）のアミノ酸配列を含むＣＤＲ－Ｈ２；
（ｃ）ＥＳＴＴＹＤＬＬＡＧＰＦＤＹ（配列番号３）のアミノ酸配列を含むＣＤＲ－Ｈ３；
（ｄ）ＫＳＳＱＴＶＬＹＳＳＮＮＫＫＹＬＡ（配列番号４）のアミノ酸配列を含むＣＤＲ－Ｌ１；
（ｅ）ＷＡＳＴＲＥＳ（配列番号５）のアミノ酸配列を含むＣＤＲ－Ｌ２；及び
（ｆ）ＱＱＹＹＳＴＰＦＴ（配列番号６）のアミノ酸配列を含むＣＤＲ－Ｌ３。 The medicament according to any one of claims 1 to 43 , wherein said anti-TIGIT antagonist antibody comprises the following CDRs:
(a) a CDR-H1 comprising the amino acid sequence of SNSAAWN (SEQ ID NO: 1);
(b) a CDR-H2 comprising the amino acid sequence of KTYYRFKWYSDYAVSVKG (SEQ ID NO:2);
(c) a CDR-H3 comprising the amino acid sequence of ESTTYDLLAGPFDY (SEQ ID NO:3);
(d) a CDR-L1 comprising the amino acid sequence of KSSQTVLYSSNNKKYLA (SEQ ID NO: 4);
(e) CDR-L2 comprising the amino acid sequence of WASTRES (SEQ ID NO:5); and (f) CDR-L3 comprising the amino acid sequence of QQYYSTPFT (SEQ ID NO:6). 前記抗ＴＩＧＩＴアンタゴニスト抗体が、以下を含む、請求項４４に記載の医薬：
（ａ）ＥＶＱＬＱＱＳＧＰＧＬＶＫＰＳＱＴＬＳＬＴＣＡＩＳＧＤＳＶＳＳＮＳＡＡＷＮＷＩＲＱＳＰＳＲＧＬＥＷＬＧＫＴＹＹＲＦＫＷＹＳＤＹＡＶＳＶＫＧＲＩＴＩＮＰＤＴＳＫＮＱＦＳＬＱＬＮＳＶＴＰＥＤＴＡＶＦＹＣＴＲＥＳＴＴＹＤＬＬＡＧＰＦＤＹＷＧＱＧＴＬＶＴＶＳＳ（配列番号１７）若しくはＱＶＱＬＱＱＳＧＰＧＬＶＫＰＳＱＴＬＳＬＴＣＡＩＳＧＤＳＶＳＳＮＳＡＡＷＮＷＩＲＱＳＰＳＲＧＬＥＷＬＧＫＴＹＹＲＦＫＷＹＳＤＹＡＶＳＶＫＧＲＩＴＩＮＰＤＴＳＫＮＱＦＳＬＱＬＮＳＶＴＰＥＤＴＡＶＦＹＣＴＲＥＳＴＴＹＤＬＬＡＧＰＦＤＹＷＧＱＧＴＬＶＴＶＳＳ（配列番号１８）のアミノ酸配列と少なくとも９５％の配列同一性を有するアミノ酸配列を含むＶＨドメイン；
（ｂ）ＤＩＶＭＴＱＳＰＤＳＬＡＶＳＬＧＥＲＡＴＩＮＣＫＳＳＱＴＶＬＹＳＳＮＮＫＫＹＬＡＷＹＱＱＫＰＧＱＰＰＮＬＬＩＹＷＡＳＴＲＥＳＧＶＰＤＲＦＳＧＳＧＳＧＴＤＦＴＬＴＩＳＳＬＱＡＥＤＶＡＶＹＹＣＱＱＹＹＳＴＰＦＴＦＧＰＧＴＫＶＥＩＫ（配列番号１９）のアミノ酸配列と少なくとも９５％の配列同一性を有するアミノ酸配列を含むＶＬドメイン；又は
（ｃ）（ａ）と同様のＶＨドメイン及び（ｂ）と同様のＶＬドメイン。 45. The medicament of claim 44 , wherein said anti-TIGIT antagonist antibody comprises:
（ａ）ＥＶＱＬＱＱＳＧＰＧＬＶＫＰＳＱＴＬＳＬＴＣＡＩＳＧＤＳＶＳＳＮＳＡＡＷＮＷＩＲＱＳＰＳＲＧＬＥＷＬＧＫＴＹＹＲＦＫＷＹＳＤＹＡＶＳＶＫＧＲＩＴＩＮＰＤＴＳＫＮＱＦＳＬＱＬＮＳＶＴＰＥＤＴＡＶＦＹＣＴＲＥＳＴＴＹＤＬＬＡＧＰＦＤＹＷＧＱＧＴＬＶＴＶＳＳ（配列番号１７）若しくはＱＶＱＬＱＱＳＧＰＧＬＶＫＰＳＱＴＬＳＬＴＣＡＩＳＧＤＳＶＳＳＮＳＡＡＷＮＷＩＲＱＳＰＳＲＧＬＥＷＬＧＫＴＹＹＲＦＫＷＹＳＤＹＡＶＳＶＫＧＲＩＴＩＮＰＤＴＳＫＮＱＦＳＬＱＬＮＳＶＴＰＥＤＴＡＶＦＹＣＴＲＥＳＴＴＹＤＬＬＡＧＰＦＤＹＷＧＱＧＴＬＶＴＶＳＳ（配列番号１８）のアミノ酸配列と少なくとも９５％の配列同一性を有するアミノ酸配列を含むＶＨドメイン；
（ｂ）ＤＩＶＭＴＱＳＰＤＳＬＡＶＳＬＧＥＲＡＴＩＮＣＫＳＳＱＴＶＬＹＳＳＮＮＫＫＹＬＡＷＹＱＱＫＰＧＱＰＰＮＬＬＩＹＷＡＳＴＲＥＳＧＶＰＤＲＦＳＧＳＧＳＧＴＤＦＴＬＴＩＳＳＬＱＡＥＤＶＡＶＹＹＣＱＱＹＹＳＴＰＦＴＦＧＰＧＴＫＶＥＩＫ（配列番号１９）のアミノ酸配列と少なくとも９５％の配列同一性を有するアミノ酸配列を含むＶＬドメイン；又は （ｃ）（ａ）と同様のＶＨドメイン及び（ｂ）と同様のＶＬドメイン. 前記抗ＴＩＧＩＴアンタゴニスト抗体が、以下を含む、請求項４５に記載の医薬：
（ａ）配列番号１７又は１８のアミノ酸配列を含むＶＨドメイン；及び
（ｂ）配列番号１９のアミノ酸配列を含むＶＬドメイン。 46. The medicament of claim 45 , wherein said anti-TIGIT antagonist antibody comprises:
(a) a VH domain comprising the amino acid sequence of SEQ ID NO:17 or 18; and (b) a VL domain comprising the amino acid sequence of SEQ ID NO:19. 前記抗ＴＩＧＩＴアンタゴニスト抗体がモノクローナル抗体、ヒト抗体、又は完全長抗体である、請求項１～４６のいずれか一項に記載の医薬。 A medicament according to any one of claims 1 to 46 , wherein said anti-TIGIT antagonist antibody is a monoclonal antibody , a human antibody or a full-length antibody . 前記抗ＴＩＧＩＴアンタゴニスト抗体が、チラゴルマブである、請求項１～４７のいずれか一項に記載の医薬。 The medicament according to any one of claims 1 to 47 , wherein said anti-TIGIT antagonist antibody is tiragolumab. 前記抗ＴＩＧＩＴアンタゴニストが、Ｆａｂ、Ｆａｂ’、Ｆａｂ’－ＳＨ、Ｆｖ、一本鎖可変断片（ｓｃＦｖ）、及び（Ｆａｂ’）２断片からなる群から選択されるＴＩＧＩＴに結合する抗体断片である、請求項１～４６のいずれか一項に記載の医薬。 wherein said anti-TIGIT antagonist is an antibody fragment that binds to TIGIT selected from the group consisting of Fab, Fab', Fab'-SH, Fv, single chain variable fragment (scFv), and (Fab') 2 fragment; A medicament according to any one of claims 1-46 . 前記抗ＴＩＧＩＴアンタゴニスト抗体がＩｇＧクラス抗体又はＩｇＧ１サブクラス抗体である、請求項１～４９のいずれか一項に記載の医薬。 The medicament according to any one of claims 1 to 49 , wherein said anti-TIGIT antagonist antibody is an IgG class antibody or an IgG1 subclass antibody . 前記抗ＴＩＧＩＴアンタゴニスト抗体が静脈内投与される、請求項１～５０のいずれか一項に記載の医薬。 A medicament according to any one of claims 1 to 50 , wherein said anti-TIGIT antagonist antibody is administered intravenously. 抗ＴＩＧＩＴアンタゴニスト抗体と、抗ＣＤ３８抗体と、請求項１～１９及び４２～５１のいずれか一項に記載の治療のための医薬に従って血液がんを有する対象に前記抗ＴＩＧＩＴアンタゴニスト抗体及び前記抗ＣＤ３８抗体を投与するための説明書を含む添付文書とを備えた、キット。 an anti-TIGIT antagonist antibody and an anti-CD38 antibody, and administering said anti-TIGIT antagonist antibody and said anti-CD38 antibody to a subject having a blood cancer according to the medicament for treatment according to any one of claims 1-19 and 42-51 and a package insert containing instructions for administering the antibody. 前記抗ＴＩＧＩＴアンタゴニスト抗体がチラゴルマブであり、前記抗ＣＤ３８抗体がダラツムマブである、請求項５２に記載のキット。 53. The kit of claim 52 , wherein said anti-TIGIT antagonist antibody is tiragolumab and said anti-CD38 antibody is daratumumab. 抗ＴＩＧＩＴアンタゴニスト抗体と、抗ＣＤ２０抗体と、請求項２０～５１のいずれか一項に記載の治療のための医薬に従って血液がんを有する対象に前記抗ＴＩＧＩＴアンタゴニスト抗体及び前記抗ＣＤ２０抗体を投与するための説明書を含む添付文書とを備えた、キット。 An anti-TIGIT antagonist antibody, an anti-CD20 antibody, and administering said anti-TIGIT antagonist antibody and said anti-CD20 antibody to a subject with blood cancer according to the medicament for treatment according to any one of claims 20 to 51 and a package insert containing instructions for. 前記抗ＴＩＧＩＴアンタゴニスト抗体がチラゴルマブであり、前記抗ＣＤ２０抗体がリツキシマブである、請求項５４に記載のキット。 55. The kit of claim 54 , wherein said anti-TIGIT antagonist antibody is tiragolumab and said anti-CD20 antibody is rituximab. 再発性又は難治性のＭＭを有する対象を処置するための、チラゴルマブを含む医薬であって、チラゴルマブが、１回以上の投薬サイクルを含む投薬レジメンで、６００ｍｇの固定用量で投与され、各投薬サイクルの長さは２１日間であり、各投薬サイクルの１日目又はその前後にチラゴルマブが投与される、医薬。 A medicament comprising tiragolumab for treating a subject with relapsed or refractory MM, wherein tiragolumab is administered at a fixed dose of 600 mg in a dosing regimen comprising one or more dosing cycles, each dosing cycle is 21 days in length and tiragolumab is administered on or before or after Day 1 of each dosing cycle. 再発性又は難治性のＮＨＬを有する対象を処置するための、チラゴルマブを含む医薬であって、チラゴルマブが、１回以上の投薬サイクルを含む投薬レジメンで、６００ｍｇの固定用量のチラゴルマブを投与することを含み、各投薬サイクルの長さは２１日間であり、各投薬サイクルの１日目又はその前後にチラゴルマブが投与される、医薬。 A medicament comprising tiragolumab for treating a subject with relapsed or refractory NHL, wherein tiragolumab is administered in a dosing regimen comprising one or more dosing cycles of 600 mg fixed dose of tiragolumab. wherein each dosing cycle is 21 days in length and tiragolumab is administered on or before or after Day 1 of each dosing cycle . チラゴルマブが単剤療法として投与される、請求項５６又は５７に記載の医薬。 58. A medicament according to claim 56 or 57 , wherein tiragolumab is administered as monotherapy. 前記投薬レジメンが少なくとも１２回の投薬サイクル又は少なくとも１６回の投薬サイクルを含む、請求項５６～５８のいずれか一項に記載の医薬。 59. A medicament according to any one of claims 56 to 58 , wherein said dosing regimen comprises at least 12 dosing cycles or at least 16 dosing cycles . 前記対象が、チラゴルマブに対する注入関連反応（ＩＲＲ）を有し、チラゴルマブのその後の投与の前に、抗ヒスタミン剤及び／又は解熱剤が、前記対象に投与される、請求項５６～５９のいずれか一項に記載の医薬。 60. Any one of claims 56-59 , wherein the subject has an infusion-related reaction (IRR) to tiragolumab, and an antihistamine and/or antipyretic is administered to the subject prior to subsequent administration of tiragolumab. The drug described in . チラゴルマブが、前記対象に静脈内投与される、請求項５６～６０のいずれか一項に記載の医薬。 The medicament according to any one of claims 56 to 60 , wherein tiragolumab is administered intravenously to said subject.
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