JPWO2021092380A5 - - Google Patents

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JPWO2021092380A5
JPWO2021092380A5 JP2022526158A JP2022526158A JPWO2021092380A5 JP WO2021092380 A5 JPWO2021092380 A5 JP WO2021092380A5 JP 2022526158 A JP2022526158 A JP 2022526158A JP 2022526158 A JP2022526158 A JP 2022526158A JP WO2021092380 A5 JPWO2021092380 A5 JP WO2021092380A5
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抗細胞傷害性Ｔリンパ球抗原－４（ＣＴＬＡ－４）抗体と組み合わせてヒト患者における切除不能または転移性黒色腫の処置に使用するための、抗リンパ球活性化遺伝子－３（ＬＡＧ－３）抗体を含む医薬組成物であって、
ここで、該患者が、Ｂ過多急速進行性線維肉腫プロト癌遺伝子（ＢＲＡＦ）の阻害剤であるチロシンキナーゼ阻害剤に対して患者の細胞を感受性にさせるＢＲＡＦ変異および／またはマイトージェン活性化細胞外シグナル調節キナーゼ（ＭＥＫ）の阻害剤であるチロシンキナーゼ阻害剤に対して患者の細胞を感受性にさせるＭＥＫ変異を有する、医薬組成物。 anti-lymphocyte activation gene-3 (LAG-3) for use in the treatment of unresectable or metastatic melanoma in human patients in combination with anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibodies A pharmaceutical composition comprising an antibody, the composition comprising:
wherein the patient has a BRAF mutation and/or a mitogen-activated extracellular signal that sensitizes the patient's cells to a tyrosine kinase inhibitor that is an inhibitor of the B-overload rapidly progressing fibrosarcoma proto-oncogene (BRAF). A pharmaceutical composition having a MEK mutation that sensitizes a patient's cells to tyrosine kinase inhibitors, which are inhibitors of regulatory kinase (MEK). 抗ＣＴＬＡ－４抗体と組み合わせてヒト患者における切除不能または転移性黒色腫の処置に使用するための、抗ＬＡＧ－３抗体を含む医薬組成物であって、
ここで、該患者が、黒色腫の処置として抗ＰＤ－１抗体を以前に投与されている、医薬組成物。 A pharmaceutical composition comprising an anti-LAG-3 antibody for use in the treatment of unresectable or metastatic melanoma in a human patient in combination with an anti-CTLA-4 antibody, comprising:
A pharmaceutical composition, wherein the patient has previously been administered an anti-PD-1 antibody as a treatment for melanoma. 患者が、Ｂ過多急速進行性線維肉腫プロト癌遺伝子（ＢＲＡＦ）の阻害剤であるチロシンキナーゼ阻害剤に対して患者の細胞を感受性にさせるＢＲＡＦ変異および／またはマイトージェン活性化細胞外シグナル調節キナーゼ（ＭＥＫ）の阻害剤であるチロシンキナーゼ阻害剤に対して患者の細胞を感受性にさせるＭＥＫ変異を有する、請求項２に記載の医薬組成物。 The patient may have a BRAF mutation that sensitizes the patient's cells to tyrosine kinase inhibitors, which are inhibitors of the B-overload rapidly progressing fibrosarcoma proto-oncogene (BRAF) and/or mitogen-activated extracellular signal-regulated kinase (MEK). 3. The pharmaceutical composition of claim 2, which has a MEK mutation that sensitizes the patient's cells to a tyrosine kinase inhibitor that is an inhibitor of ). ヒト患者における切除不能または転移性黒色腫を処置する方法において使用するための、抗ＬＡＧ－３抗体を含む医薬組成物であって、該方法が、約３６０ｍｇ、約７２０ｍｇ、約１０８０ｍｇ、または約１２００ｍｇの投与量の抗ＬＡＧ－３抗体および約３ｍｇ／ｋｇの投与量の抗ＣＴＬＡ－４抗体を該患者に投与することを含む、医薬組成物。 A pharmaceutical composition comprising an anti-LAG-3 antibody for use in a method of treating unresectable or metastatic melanoma in a human patient, the method comprising: of an anti-LAG-3 antibody and a dose of about 3 mg/kg of an anti-CTLA-4 antibody to the patient. 患者が、黒色腫の処置として抗ＰＤ－１抗体を以前に投与されている、請求項４に記載の医薬組成物。 5. The pharmaceutical composition of claim 4, wherein the patient has previously been administered an anti-PD-1 antibody as a treatment for melanoma. 患者の腫瘍細胞がＢＲＡＦ Ｖ６００変異を含む、請求項４または５に記載の医薬組成物。 6. A pharmaceutical composition according to claim 4 or 5, wherein the patient's tumor cells contain a BRAF V600 mutation. 患者が組織学的に確認された切除不能なステージＩＩＩまたはステージＩＶの黒色腫を有する、請求項１から６のいずれか一項に記載の医薬組成物。 7. A pharmaceutical composition according to any one of claims 1 to 6, wherein the patient has histologically confirmed unresectable stage III or stage IV melanoma. 患者由来の腫瘍組織における少なくとも約１％の免疫細胞がＬＡＧ－３を発現し、患者由来の腫瘍組織における少なくとも約１％の腫瘍細胞がＰＤ－Ｌ１を発現する、請求項１から７のいずれか一項に記載の医薬組成物。 Any of claims 1 to 7, wherein at least about 1% of the immune cells in the patient-derived tumor tissue express LAG-3 and at least about 1% of the tumor cells in the patient-derived tumor tissue express PD-L1. Pharmaceutical composition according to item 1. 抗ＬＡＧ－３抗体が全長抗体を含むか、
抗ＬＡＧ－３抗体が、モノクローナル抗体、ヒト抗体、ヒト化抗体、キメラ抗体、または多重特異性抗体を含むか、
抗ＬＡＧ－３抗体が、二重親和性再標的化抗体（ＤＡＲＴ）、ＤＶＤ－１ｇまたは二重特異性抗体である多重特異性抗体を含むか、あるいは
抗ＬＡＧ－３抗体が、Ｆ（ａｂ’）２フラグメント、Ｆａｂ’フラグメント、Ｆａｂフラグメント、Ｆｖフラグメント、ｓｃＦｖフラグメント、ｄｓＦｖフラグメント、ｄＡｂフラグメントまたは一本鎖結合ポリペプチドペプチドを含む、
請求項１から８のいずれか一項に記載の医薬組成物。 whether the anti-LAG-3 antibody includes a full-length antibody;
whether the anti-LAG-3 antibody comprises a monoclonal antibody, a human antibody, a humanized antibody, a chimeric antibody, or a multispecific antibody;
The anti-LAG-3 antibody comprises a multispecific antibody that is a dual affinity retargeting antibody (DART), DVD-1g or a bispecific antibody, or the anti-LAG-3 antibody comprises ) 2 fragment, Fab' fragment, Fab fragment, Fv fragment, scFv fragment, dsFv fragment, dAb fragment or single chain binding polypeptide peptide,
A pharmaceutical composition according to any one of claims 1 to 8. 抗ＬＡＧ－３抗体が、
（ａ）ＢＭＳ－９８６０１６(レラトリマブ)、ＩＭＰ７３１（Ｈ５Ｌ７ＢＷ）、ＭＫ－４２８０（２８Ｇ－１０）、ＲＥＧＮ３７６７(フィアンリマブ)、ＧＳＫ２８３１７８１、ヒト化ＢＡＰ０５０、ＩＭＰ－７０１（ＬＡＧ－５２５、イエラミリマブ）、ａＬＡＧ３（０４１４）、ａＬＡＧ３（０４１６）、Ｓｙｍ０２２、ＴＳＲ－０３３、ＴＳＲ－０７５、ＸｍＡｂ２２８４１、ＭＧＤ０１３、ＢＩ７５４１１１、ＦＳ１１８、Ｐ １３Ｂ０２－３０、ＡＶＡ－０１７、２５Ｆ７、ＡＧＥＮ１７４６またはそれらの抗原結合部分、
（ｂ）配列番号３に記載の配列を有する重鎖可変領域のＣＤＲ１ドメイン、ＣＤＲ２ドメインおよびＣＤＲ３ドメインならびに配列番号５に記載の配列を有する軽鎖可変領域のＣＤＲ１ドメイン、ＣＤＲ２ドメインおよびＣＤＲ３ドメイン、
（ｃ）配列番号７、８、および９にそれぞれ記載の配列を含む重鎖可変領域ＣＤＲ１、ＣＤＲ２、およびＣＤＲ３ならびに配列番号１０、１１、および１２にそれぞれ記載の配列を含む軽鎖可変領域ＣＤＲ１、ＣＤＲ２およびＣＤＲ３、
（ｄ）配列番号３および５にそれぞれ記載の配列を含む重鎖および軽鎖可変領域、
（ｅ）配列番号１および２にそれぞれ記載の配列を含む重鎖および軽鎖、または
（ｆ）配列番号３０および２にそれぞれ記載の配列を含む重鎖および軽鎖
を含む、請求項１から９のいずれか一項に記載の医薬組成物。 The anti-LAG-3 antibody
(a) BMS-986016 (leratrimab), IMP731 (H5L7BW), MK-4280 (28G-10), REGN3767 (fianlimab), GSK2831781, humanized BAP050, IMP-701 (LAG-525, ieramilimab), aLAG3 (0414) , aLAG3(0416), Sym022, TSR-033, TSR-075, XmAb22841, MGD013, BI754111, FS118, P 13B02-30, AVA-017, 25F7, AGEN1746 or antigen-binding portions thereof,
(b) CDR1 domain, CDR2 domain and CDR3 domain of a heavy chain variable region having the sequence set forth in SEQ ID NO: 3 and CDR1 domain, CDR2 domain and CDR3 domain of a light chain variable region having the sequence set forth in SEQ ID NO: 5;
(c) heavy chain variable region CDR1, CDR2, and CDR3 comprising the sequences set forth in SEQ ID NOs: 7, 8, and 9, respectively, and light chain variable region CDR1 comprising the sequences set forth in SEQ ID NOs: 10, 11, and 12, respectively; CDR2 and CDR3,
(d) heavy chain and light chain variable regions comprising the sequences set forth in SEQ ID NOs: 3 and 5, respectively;
(e) a heavy chain and a light chain comprising the sequences set forth in SEQ ID NOs: 1 and 2, respectively; or (f) a heavy chain and a light chain comprising the sequences set forth in SEQ ID NOs: 30 and 2, respectively. The pharmaceutical composition according to any one of . 抗ＣＴＬＡ－４抗体が全長抗体を含むか、
抗ＣＴＬＡ－４抗体が、モノクローナル抗体、ヒト抗体、ヒト化抗体、キメラ抗体、または多重特異性抗体を含むか、
抗ＣＴＬＡ－４抗体が、二重親和性再標的化抗体（ＤＡＲＴ）、ＤＶＤ－１ｇまたは二重特異性抗体である多重特異性抗体を含むか、あるいは
抗ＣＴＬＡ－４抗体が、Ｆ（ａｂ’）２フラグメント、Ｆａｂ’フラグメント、Ｆａｂフラグメント、Ｆｖフラグメント、ｓｃＦｖフラグメント、ｄｓＦｖフラグメント、ｄＡｂフラグメントまたは一本鎖結合ポリペプチドペプチドを含む、
請求項１から１０のいずれか一項に記載の医薬組成物。 whether the anti-CTLA-4 antibody includes a full-length antibody;
whether the anti-CTLA-4 antibody comprises a monoclonal antibody, a human antibody, a humanized antibody, a chimeric antibody, or a multispecific antibody;
The anti-CTLA-4 antibody comprises a multispecific antibody that is a dual affinity retargeting antibody (DART), DVD-1g or a bispecific antibody, or the anti-CTLA-4 antibody comprises ) 2 fragment, Fab' fragment, Fab fragment, Fv fragment, scFv fragment, dsFv fragment, dAb fragment or single chain binding polypeptide peptide,
A pharmaceutical composition according to any one of claims 1 to 10. 抗ＣＴＬＡ－４抗体が、
（ａ）イピリムマブ、トレメリムマブ、ＭＫ－１３０８、ＡＧＥＮ－１８８４、またはそれらの抗原結合部分、
（ｂ）配列番号３４に記載の配列を有する重鎖可変領域のＣＤＲ１ドメイン、ＣＤＲ２ドメインおよびＣＤＲ３ドメインならびに配列番号３２に記載の配列を有する軽鎖可変領域のＣＤＲ１ドメイン、ＣＤＲ２ドメインおよびＣＤＲ３ドメイン、
（ｃ）配列番号３５、３６、および３７にそれぞれ記載の配列を含む重鎖可変領域ＣＤＲ１、ＣＤＲ２、およびＣＤＲ３ならびに配列番号３８、３９、および４０にそれぞれ記載の配列を含む軽鎖可変領域ＣＤＲ１、ＣＤＲ２、およびＣＤＲ３、
（ｄ）配列番号３４および３２にそれぞれ記載の配列を含む重鎖および軽鎖可変領域、または
（ｅ）イピリムマブの重鎖および軽鎖
を含む、請求項１から１１のいずれか一項に記載の医薬組成物。 The anti-CTLA-4 antibody is
(a) ipilimumab, tremelimumab, MK-1308, AGEN-1884, or an antigen-binding portion thereof;
(b) CDR1 domain, CDR2 domain and CDR3 domain of a heavy chain variable region having the sequence set forth in SEQ ID NO: 34 and CDR1 domain, CDR2 domain and CDR3 domain of a light chain variable region having the sequence set forth in SEQ ID NO: 32;
(c) heavy chain variable region CDR1, CDR2, and CDR3 comprising the sequences set forth in SEQ ID NOs: 35, 36, and 37, respectively, and light chain variable region CDR1 comprising the sequences set forth in SEQ ID NOs: 38, 39, and 40, respectively; CDR2, and CDR3,
(d) a heavy chain and a light chain variable region comprising the sequences set forth in SEQ ID NOs: 34 and 32, respectively; or (e) a heavy chain and a light chain of ipilimumab. Pharmaceutical composition. 抗ＬＡＧ－３抗体および抗ＣＴＬＡ－４抗体が非経口投与用に製剤される、請求項１から１２のいずれか一項に記載の医薬組成物。 13. A pharmaceutical composition according to any one of claims 1 to 12, wherein the anti-LAG-3 and anti-CTLA-4 antibodies are formulated for parenteral administration. 抗ＬＡＧ－３抗体および抗ＣＴＬＡ－４抗体が静脈内投与用、筋肉内投与用、皮下投与用、腹腔内投与用、または脊髄投与用に製剤される、請求項１から１３のいずれか一項に記載の医薬組成物。 14. Any one of claims 1 to 13, wherein the anti-LAG-3 antibody and anti-CTLA-4 antibody are formulated for intravenous, intramuscular, subcutaneous, intraperitoneal, or spinal administration. The pharmaceutical composition described in . 抗ＬＡＧ－３抗体および抗ＣＴＬＡ－４抗体が別個に製剤される、請求項１から１４のいずれか一項に記載の医薬組成物。 15. A pharmaceutical composition according to any one of claims 1 to 14, wherein the anti-LAG-3 antibody and the anti-CTLA-4 antibody are formulated separately. 抗ＬＡＧ－３抗体および抗ＣＴＬＡ－４抗体が一剤として製剤される、請求項１から１４のいずれか一項に記載の医薬組成物。 15. The pharmaceutical composition according to any one of claims 1 to 14, wherein the anti-LAG-3 antibody and the anti-CTLA-4 antibody are formulated as a single agent.
JP2022526158A 2019-11-08 2020-11-06 LAG-3 antagonists for the treatment of melanoma Pending JP2022553851A (en)

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PCT/US2020/059411 WO2021092380A1 (en) 2019-11-08 2020-11-06 Lag-3 antagonist therapy for melanoma

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