JPWO2021257124A5 - - Google Patents
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- JPWO2021257124A5 JPWO2021257124A5 JP2022577590A JP2022577590A JPWO2021257124A5 JP WO2021257124 A5 JPWO2021257124 A5 JP WO2021257124A5 JP 2022577590 A JP2022577590 A JP 2022577590A JP 2022577590 A JP2022577590 A JP 2022577590A JP WO2021257124 A5 JPWO2021257124 A5 JP WO2021257124A5
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- 239000005557 antagonist Substances 0.000 claims 116
- 239000003814 drug Substances 0.000 claims 100
- 102100040678 Programmed cell death protein 1 Human genes 0.000 claims 51
- 101710089372 Programmed cell death protein 1 Proteins 0.000 claims 51
- 206010061534 Oesophageal squamous cell carcinoma Diseases 0.000 claims 36
- 208000036765 Squamous cell carcinoma of the esophagus Diseases 0.000 claims 36
- 208000007276 esophageal squamous cell carcinoma Diseases 0.000 claims 36
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 claims 34
- 125000003275 alpha amino acid group Chemical group 0.000 claims 32
- 229940079593 drug Drugs 0.000 claims 18
- 229910052697 platinum Inorganic materials 0.000 claims 17
- 229940123237 Taxane Drugs 0.000 claims 15
- DKPFODGZWDEEBT-QFIAKTPHSA-N taxane Chemical class C([C@]1(C)CCC[C@@H](C)[C@H]1C1)C[C@H]2[C@H](C)CC[C@@H]1C2(C)C DKPFODGZWDEEBT-QFIAKTPHSA-N 0.000 claims 15
- 102000008096 B7-H1 Antigen Human genes 0.000 claims 12
- 108010074708 B7-H1 Antigen Proteins 0.000 claims 12
- 229940123751 PD-L1 antagonist Drugs 0.000 claims 10
- 238000011127 radiochemotherapy Methods 0.000 claims 7
- 108091007491 NSP3 Papain-like protease domains Proteins 0.000 claims 6
- 238000004519 manufacturing process Methods 0.000 claims 6
- 230000000750 progressive effect Effects 0.000 claims 5
- 229960003852 atezolizumab Drugs 0.000 claims 4
- 239000012634 fragment Substances 0.000 claims 4
- 238000012423 maintenance Methods 0.000 claims 4
- 101000831007 Homo sapiens T-cell immunoreceptor with Ig and ITIM domains Proteins 0.000 claims 3
- 102100024834 T-cell immunoreceptor with Ig and ITIM domains Human genes 0.000 claims 3
- 238000002512 chemotherapy Methods 0.000 claims 3
- 238000001356 surgical procedure Methods 0.000 claims 3
- 229950007133 tiragolumab Drugs 0.000 claims 3
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 2
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 2
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 2
- 229940124060 PD-1 antagonist Drugs 0.000 claims 2
- 238000002619 cancer immunotherapy Methods 0.000 claims 2
- 229950009791 durvalumab Drugs 0.000 claims 2
- 230000006698 induction Effects 0.000 claims 2
- 230000001394 metastastic effect Effects 0.000 claims 2
- 206010061289 metastatic neoplasm Diseases 0.000 claims 2
- 102000039446 nucleic acids Human genes 0.000 claims 2
- 108020004707 nucleic acids Proteins 0.000 claims 2
- 150000007523 nucleic acids Chemical class 0.000 claims 2
- 229960001592 paclitaxel Drugs 0.000 claims 2
- 230000000306 recurrent effect Effects 0.000 claims 2
- 230000004083 survival effect Effects 0.000 claims 2
- 230000009885 systemic effect Effects 0.000 claims 2
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims 2
- 108010058566 130-nm albumin-bound paclitaxel Proteins 0.000 claims 1
- 206010061818 Disease progression Diseases 0.000 claims 1
- 208000007433 Lymphatic Metastasis Diseases 0.000 claims 1
- 206010027459 Metastases to lymph nodes Diseases 0.000 claims 1
- 229930012538 Paclitaxel Natural products 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 claims 1
- 229960004562 carboplatin Drugs 0.000 claims 1
- 190000008236 carboplatin Chemical compound 0.000 claims 1
- 229960004316 cisplatin Drugs 0.000 claims 1
- DQLATGHUWYMOKM-UHFFFAOYSA-L cisplatin Chemical compound N[Pt](N)(Cl)Cl DQLATGHUWYMOKM-UHFFFAOYSA-L 0.000 claims 1
- 238000003745 diagnosis Methods 0.000 claims 1
- 230000005750 disease progression Effects 0.000 claims 1
- 229940115924 etigilimab Drugs 0.000 claims 1
- 208000025402 neoplasm of esophagus Diseases 0.000 claims 1
- 238000011518 platinum-based chemotherapy Methods 0.000 claims 1
- 238000001959 radiotherapy Methods 0.000 claims 1
Claims (75)
(b)抗TIGITアンタゴニスト抗体が、以下の超可変領域(HVR):
SNSAAWN(配列番号1)のアミノ酸配列を含むHVR-H1配列;
KTYYRFKWYSDYAVSVKG(配列番号2)のアミノ酸配列を含むHVR-H2配列;
ESTTYDLLAGPFDY(配列番号3)のアミノ酸配列を含むHVR-H3配列;
KSSQTVLYSSNNKKYLA(配列番号4)のアミノ酸配列を含むHVR-L1配列;
WASTRES(配列番号5)のアミノ酸配列を含むHVR-L2配列;及び
QQYYSTPFT(配列番号6)のアミノ酸配列を含むHVR-L3配列
を含む、並びに/又は
(c)抗TIGITアンタゴニスト抗体が、配列番号17又は18のアミノ酸配列を含むVHドメイン、及び配列番号19のアミノ酸配列を含むVLドメインを含む、請求項1~11のいずれか一項に記載の医薬。 (a) the anti-TIGIT antagonist antibody is tiragolumab, vivostrimab, etigilimab, or EOS084448;
(b) The anti-TIGIT antagonist antibody has the following hypervariable region (HVR):
HVR-H1 sequence comprising the amino acid sequence of SNSAAWN (SEQ ID NO: 1);
HVR-H2 sequence comprising the amino acid sequence of KTYYRFKWYSDYAVSVKG (SEQ ID NO: 2);
HVR-H3 sequence comprising the amino acid sequence of ESTTYDLLAGPFDY (SEQ ID NO: 3);
HVR-L1 sequence comprising the amino acid sequence of KSSQTVLYSSNNKKYLA (SEQ ID NO: 4);
HVR-L2 sequence comprising the amino acid sequence of WASTRES (SEQ ID NO: 5); and HVR-L3 sequence comprising the amino acid sequence of QQYYSTPFT (SEQ ID NO: 6) , and/or
(c) The medicament according to any one of claims 1 to 11, wherein the anti-TIGIT antagonist antibody comprises a VH domain comprising the amino acid sequence of SEQ ID NO: 17 or 18, and a VL domain comprising the amino acid sequence of SEQ ID NO: 19. .
(b)抗PD-L1アンタゴニスト抗体が、以下のHVR:
GFTFSDSWIH(配列番号20)のアミノ酸配列を含むHVR-H1配列;
AWISPYGGSTYYADSVKG(配列番号21)のアミノ酸配列を含むHVR-H2配列;
RHWPGGFDY(配列番号22)のアミノ酸配列を含むHVR-H3配列;
RASQDVSTAVA(配列番号23)のアミノ酸配列を含むHVR-L1配列;
SASFLYS(配列番号24)のアミノ酸配列を含むHVR-L2配列;及び
QQYLYHPAT(配列番号25)のアミノ酸配列を含むHVR-L3配列
を含む、並びに/又は
(c)抗PD-L1アンタゴニスト抗体が、配列番号26のアミノ酸配列を含むVHドメイン、及び配列番号27のアミノ酸配列を含むVLドメインを含む、請求項1~16のいずれか一項に記載の医薬。 (a) the anti-PD-L1 antagonist antibody is atezolizumab, MSB0010718C, MDX-1105 or MEDI4736;
(b) The anti-PD-L1 antagonist antibody has the following HVR:
HVR-H1 sequence comprising the amino acid sequence of GFTFSDSWIH (SEQ ID NO: 20);
HVR-H2 sequence comprising the amino acid sequence of AWISPYGGSTYYADSVKG (SEQ ID NO: 21);
HVR-H3 sequence comprising the amino acid sequence of RHWPGGFDY (SEQ ID NO: 22);
HVR-L1 sequence comprising the amino acid sequence of RASQDVSTAVA (SEQ ID NO: 23);
an HVR-L2 sequence comprising the amino acid sequence of SASFLYS (SEQ ID NO: 24); and
HVR-L3 sequence containing the amino acid sequence of QQYLYHPAT (SEQ ID NO: 25)
including and/or
(c) The medicament according to any one of claims 1 to 16 , wherein the anti-PD-L1 antagonist antibody comprises a VH domain comprising the amino acid sequence of SEQ ID NO: 26 and a VL domain comprising the amino acid sequence of SEQ ID NO: 27. .
(b)PD-1軸結合アンタゴニストが、3週間ごとに約80mg~約1600mg、3週間ごとに約800mg~約1400mg、3週間ごとに約1200mgの固定用量で投与される、請求項35~40のいずれか一項に記載の医薬。 (a) the anti-TIGIT antagonist antibody is administered at a fixed dose of about 30 mg to about 1200 mg every 3 weeks , about 30 mg to about 800 mg every 3 weeks, or about 600 mg every 3 weeks , or
(b) the PD-1 axis binding antagonist is administered at a fixed dose of about 80 mg to about 1600 mg every 3 weeks, about 800 mg to about 1400 mg every 3 weeks, about 1200 mg every 3 weeks , The medicament according to any one of .
(b)白金薬剤が、(i)3週間ごとに約20~200mg/m 2 、(ii)3週間ごとに約40~120mg/m 2 、或いは(iii)3週間ごとに約60~80mg/m 2 の用量で投与される、請求項35~41のいずれか一項に記載の医薬。 (a) the taxane is administered at a dose of (i) about 100-250 mg/m 2 every 3 weeks , (ii) 150-200 mg/m 2 every 3 weeks, or (iii) 175 mg/m 2 every 3 weeks; administered or
(b) the platinum drug is administered at a dose of (i) about 20-200 mg/m 2 every 3 weeks , (ii) about 40-120 mg/m 2 every 3 weeks , or (iii) about 60-80 mg/m 2 every 3 weeks; 42. A medicament according to any one of claims 35 to 41 , administered in a dose of m2 .
(b)(i)抗TIGITアンタゴニスト抗体が、4週間ごとに約700mg~約1000mg、4週間ごとに約800mg~約900mg、或いは4週間ごとに約840mgの固定用量で投与され、且つ(ii)PD-1軸結合アンタゴニストが、4週間ごとに約400mg~約2000mg、4週間ごとに約1600mg~約1800mg、或いは4週間ごとに約1680mgの固定用量で投与される、請求項35~40のいずれか一項に記載の医薬。 (a) (i) the anti-TIGIT antagonist antibody is administered at a fixed dose of about 300 mg to about 800 mg every two weeks , about 400 mg to about 500 mg every two weeks, or about 420 mg every two weeks , and (ii) the PD-1 axis binding antagonist is administered at a fixed dose of about 200 mg to about 1200 mg every two weeks, about 800 mg to about 1000 mg every two weeks, or about 840 mg every two weeks, or
(b) (i) the anti-TIGIT antagonist antibody is administered at a fixed dose of about 700 mg to about 1000 mg every 4 weeks, about 800 mg to about 900 mg every 4 weeks, or about 840 mg every 4 weeks, and (ii) Any of claims 35-40 , wherein the PD-1 axis binding antagonist is administered at a fixed dose of about 400 mg to about 2000 mg every 4 weeks, about 1600 mg to about 1800 mg every 4 weeks, or about 1680 mg every 4 weeks . The medicine described in item (1) above.
(b)抗TIGITアンタゴニスト抗体が、4週間ごとに約840mgの固定用量で投与され、PD-1軸結合アンタゴニストが、4週間ごとに約1680mgの固定用量で投与される、請求項47に記載の医薬。 (a) the anti-TIGIT antagonist antibody is administered at a fixed dose of about 420 mg every two weeks and the PD-1 axis binding antagonist is administered at a fixed dose of about 840 mg every two weeks , or
(b) the anti-TIGIT antagonist antibody is administered at a fixed dose of about 840 mg every 4 weeks and the PD-1 axis binding antagonist is administered at a fixed dose of about 1680 mg every 4 weeks . Medicine .
SNSAAWN(配列番号1)のアミノ酸配列を含むHVR-H1配列;
KTYYRFKWYSDYAVSVKG(配列番号2)のアミノ酸配列を含むHVR-H2配列;
ESTTYDLLAGPFDY(配列番号3)のアミノ酸配列を含むHVR-H3配列;
KSSQTVLYSSNNKKYLA(配列番号4)のアミノ酸配列を含むHVR-L1配列;
WASTRES(配列番号5)のアミノ酸配列を含むHVR-L2配列;及び
QQYYSTPFT(配列番号6)のアミノ酸配列を含むHVR-L3配列
を含む、並びに/又は
(c)抗TIGITアンタゴニスト抗体が、配列番号17又は18のアミノ酸配列を含むVHドメイン、及び配列番号19のアミノ酸配列を含むVLドメインを含む、請求項35~52のいずれか一項に記載の医薬。 (a) The anti-TIGIT antagonist antibody has the following hypervariable region (HVR):
HVR-H1 sequence comprising the amino acid sequence of SNSAAWN (SEQ ID NO: 1);
HVR-H2 sequence comprising the amino acid sequence of KTYYRFKWYSDYAVSVKG (SEQ ID NO: 2);
HVR-H3 sequence comprising the amino acid sequence of ESTTYDLLAGPFDY (SEQ ID NO: 3);
HVR-L1 sequence comprising the amino acid sequence of KSSQTVLYSSNNKKYLA (SEQ ID NO: 4);
HVR-L2 sequence comprising the amino acid sequence of WASTRES (SEQ ID NO: 5); and HVR-L3 sequence comprising the amino acid sequence of QQYYSTPFT (SEQ ID NO: 6) , and/or
(c) The medicament according to any one of claims 35 to 52, wherein the anti-TIGIT antagonist antibody comprises a VH domain comprising the amino acid sequence of SEQ ID NO: 17 or 18 and a VL domain comprising the amino acid sequence of SEQ ID NO: 19. .
(b)抗PD-L1アンタゴニスト抗体が、以下のHVR:
GFTFSDSWIH(配列番号20)のアミノ酸配列を含むHVR-H1配列;
AWISPYGGSTYYADSVKG(配列番号21)のアミノ酸配列を含むHVR-H2配列;
RHWPGGFDY(配列番号22)のアミノ酸配列を含むHVR-H3配列;
RASQDVSTAVA(配列番号23)のアミノ酸配列を含むHVR-L1配列;
SASFLYS(配列番号24)のアミノ酸配列を含むHVR-L2配列;及び
QQYLYHPAT(配列番号25)のアミノ酸配列を含むHVR-L3配列
を含む、並びに/又は
(c)抗PD-L1アンタゴニスト抗体が、配列番号26のアミノ酸配列を含むVHドメイン、及び配列番号27のアミノ酸配列を含むVLドメインを含む、請求項35~57のいずれか一項に記載の医薬。 (a) the anti-PD-L1 antagonist antibody is atezolizumab, MSB0010718C, MDX-1105 or MEDI4736 ;
(b) The anti-PD-L1 antagonist antibody has the following HVR:
HVR-H1 sequence comprising the amino acid sequence of GFTFSDSWIH (SEQ ID NO: 20);
HVR-H2 sequence comprising the amino acid sequence of AWISPYGGSTYYADSVKG (SEQ ID NO: 21);
HVR-H3 sequence comprising the amino acid sequence of RHWPGGFDY (SEQ ID NO: 22);
HVR-L1 sequence comprising the amino acid sequence of RASQDVSTAVA (SEQ ID NO: 23);
an HVR-L2 sequence comprising the amino acid sequence of SASFLYS (SEQ ID NO: 24); and
HVR-L3 sequence containing the amino acid sequence of QQYLYHPAT (SEQ ID NO: 25)
including and/or
(c) The medicament according to any one of claims 35 to 57, wherein the anti-PD-L1 antagonist antibody comprises a VH domain comprising the amino acid sequence of SEQ ID NO: 26 and a VL domain comprising the amino acid sequence of SEQ ID NO: 27. .
(a)PD-1軸結合アンタゴニスト及び抗TIGITアンタゴニスト抗体を用いずにタキサン及び白金薬剤を用いた治療と比較して、対象又は対象集団のPFS、OS、及び/又はDORの増加、
(b)PD-1軸結合アンタゴニスト及び抗TIGITアンタゴニスト抗体を用いずにタキサン及び白金薬剤を用いた治療と比較して、対象又は対象集団のOSの増加、又は
(c)PD-1軸結合アンタゴニスト及び抗TIGITアンタゴニスト抗体を用いずにタキサン及び白金薬剤を用いた治療と比較して、対象又は対象集団のDORの増加
をもたらす、請求項35~68のいずれか一項に記載の医薬。 The treatment is
(a) an increase in PFS , OS, and/or DOR in a subject or population of subjects as compared to treatment with a taxane and platinum drug without a PD-1 axis binding antagonist and an anti-TIGIT antagonist antibody ;
(b) an increase in the OS of the subject or subject population compared to treatment with a taxane and platinum drug without a PD-1 axis binding antagonist and an anti-TIGIT antagonist antibody, or
(c) increased DOR in a subject or population compared to treatment with a taxane and platinum drug without a PD-1 axis binding antagonist and an anti-TIGIT antagonist antibody;
69. A medicament according to any one of claims 35 to 68 , which provides:
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNPCT/CN2020/096746 | 2020-06-18 | ||
CN2020096746 | 2020-06-18 | ||
PCT/US2021/015084 WO2021257124A1 (en) | 2020-06-18 | 2021-01-26 | Treatment with anti-tigit antibodies and pd-1 axis binding antagonists |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2023531200A JP2023531200A (en) | 2023-07-21 |
JPWO2021257124A5 true JPWO2021257124A5 (en) | 2024-02-05 |
Family
ID=74661506
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Application Number | Title | Priority Date | Filing Date |
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JP2022577590A Pending JP2023531200A (en) | 2020-06-18 | 2021-01-26 | Treatment with anti-TIGIT antibody and PD-1 axis binding antagonist |
Country Status (12)
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US (1) | US20210395366A1 (en) |
EP (1) | EP4168118A1 (en) |
JP (1) | JP2023531200A (en) |
KR (1) | KR20230024368A (en) |
CN (1) | CN115916348A (en) |
AU (1) | AU2021293507A1 (en) |
BR (1) | BR112022025801A2 (en) |
CA (1) | CA3181672A1 (en) |
IL (1) | IL298946A (en) |
MX (1) | MX2022015881A (en) |
TW (1) | TW202200616A (en) |
WO (1) | WO2021257124A1 (en) |
Families Citing this family (3)
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EP3689909A4 (en) * | 2017-09-29 | 2021-12-29 | Jiangsu Hengrui Medicine Co., Ltd. | Tigit antibody, antigen-binding fragment thereof, and medical use thereof |
US11735303B2 (en) * | 2021-06-22 | 2023-08-22 | David Haase | Apparatus and method for determining a composition of a replacement therapy treatment |
WO2024083074A1 (en) * | 2022-10-17 | 2024-04-25 | Beigene, Ltd. | Formulations containing anti-tigit antibody and methods of use thereof |
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