JP7135068B2 - Egfr阻害剤と抗ヒトvegfr-2抗体との組み合わせ - Google Patents
Egfr阻害剤と抗ヒトvegfr-2抗体との組み合わせ Download PDFInfo
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- JP7135068B2 JP7135068B2 JP2020508540A JP2020508540A JP7135068B2 JP 7135068 B2 JP7135068 B2 JP 7135068B2 JP 2020508540 A JP2020508540 A JP 2020508540A JP 2020508540 A JP2020508540 A JP 2020508540A JP 7135068 B2 JP7135068 B2 JP 7135068B2
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
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- Immunology (AREA)
- Organic Chemistry (AREA)
- Endocrinology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Physiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nutrition Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
Description
EGFR TKI療法後に進行した、進行性EGFR T790M陽性NSCLCを有し、第3世代EGFR TKIに未感作の適格患者が登録された。用量設定部分では、用量漸減設計に従い、患者に、毎日の経口オシメルチニブ(80mg)、および2週間ごとに1日目(D1)に静脈内(IV)10mg/kgのラムシルマブを投与した(治療群A)。用量設定部分と拡大部分との両方において、患者に、疾患が進行するかまたは中止基準に合うまで、試験治療薬を施した。本試験の主要目的は、オシメルチニブと組み合わせたラムシルマブの安全性および忍容性を評価することであり、副次的目的には、予備的な有効性が含まれる。
配列表
配列番号1(抗ヒトVEGFR-2抗体、LCVR)(人工配列)
DIQMTQSPSSVSASIGDRVTITCRASQGIDNWLGWYQQKPGKAPKLLIYDASNLDTGVPSRFSGSGSGTYFTLTISSLQAEDFAVYFCQQAKAFPPTFGGGTKVDIK
配列番号2(抗ヒトVEGFR-2抗体、HCVR)(人工配列)
EVQLVQSGGGLVKPGGSLRLSCAASGFTFSSYSMNWVRQAPGKGLEWVSSISSSSSYIYYADSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARVTDAFDIWGQGTMVTVSS
配列番号3(抗ヒトVEGFR-2抗体、LC)(人工配列)
DIQMTQSPSSVSASIGDRVTITCRASQGIDNWLGWYQQKPGKAPKLLIYDASNLDTGVPSRFSGSGSGTYFTLTISSLQAEDFAVYFCQQAKAFPPTFGGGTKVDIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
配列番号4(抗ヒトVEGFR-2抗体、HC)(人工配列)
EVQLVQSGGGLVKPGGSLRLSCAASGFTFSSYSMNWVRQAPGKGLEWVSSISSSSSYIYYADSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCARVTDAFDIWGQGTMVTVSSASTKGPSVLPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
配列番号5(ヒトVEGFR-2)(ホモサピエンス)
MQSKVLLAVALWLCVETRAASVGLPSVSLDLPRLSIQKDILTIKANTTLQITCRGQRDLDWLWPNNQSGSEQRVEVTECSDGLFCKTLTIPKVIGNDTGAYKCFYRETDLASVIYVYVQDYRSPFIASVSDQHGVVYITENKNKTVVIPCLGSISNLNVSLCARYPEKRFVPDGNRISWDSKKGFTIPSYMISYAGMVFCEAKINDESYQSIMYIVVVVGYRIYDVVLSPSHGIELSVGEKLVLNCTARTELNVGIDFNWEYPSSKHQHKKLVNRDLKTQSGSEMKKFLSTLTIDGVTRSDQGLYTCAASSGLMTKKNSTFVRVHEKPFVAFGSGMESLVEATVGERVRIPAKYLGYPPPEIKWYKNGIPLESNHTIKAGHVLTIMEVSERDTGNYTVILTNPISKEKQSHVVSLVVYVPPQIGEKSLISPVDSYQYGTTQTLTCTVYAIPPPHHIHWYWQLEEECANEPSQAVSVTNPYPCEEWRSVEDFQGGNKIEVNKNQFALIEGKNKTVSTLVIQAANVSALYKCEAVNKVGRGERVISFHVTRGPEITLQPDMQPTEQESVSLWCTADRSTFENLTWYKLGPQPLPIHVGELPTPVCKNLDTLWKLNATMFSNSTNDILIMELKNASLQDQGDYVCLAQDRKTKKRHCVVRQLTVLERVAPTITGNLENQTTSIGESIEVSCTASGNPPPQIMWFKDNETLVEDSGIVLKDGNRNLTIRRVRKEDEGLYTCQACSVLGCAKVEAFFIIEGAQEKTNLEIIILVGTAVIAMFFWLLLVIILRTVKRANGGELKTGYLSIVMDPDELPLDEHCERLPYDASKWEFPRDRLKLGKPLGRGAFGQVIEADAFGIDKTATCRTVAVKMLKEGATHSEHRALMSELKILIHIGHHLNVVNLLGACTKPGGPLMVIVEFCKFGNLSTYLRSKRNEFVPYKTKGARFRQGKDYVGAIPVDLKRRLDSITSSQSSASSGFVEEKSLSDVEEEEAPEDLYKDFLTLEHLICYSFQVAKGMEFLASRKCIHRDLAARNILLSEKNVVKICDFGLARDIYKDPDYVRKGDARLPLKWMAPETIFDRVYTIQSDVWSFGVLLWEIFSLGASPYPGVKIDEEFCRRLKEGTRMRAPDYTTPEMYQTMLDCWHGEPSQRPTFSELVEHLGNLLQANAQQDGKDYIVLPISETLSMEEDSGLSLPTSPVSCMEEEEVCDPKFHYDNTAGISQYLQNSKRKSRPVSVKTFEDIPLEEPEVKVIPDDNQTDSGMVLASEELKTLEDRTKLSPSFGGMVPSKSRESVASEGSNQTSGYQSGYHSDDTDTTVYSSEEAELLKLIEIGVQTGSTAQILQPDSGTTLSSPPV
Claims (6)
- 転移性EGFR T790M陽性非小細胞肺癌を有する患者の治療において、オシメルチニブまたはその薬学的に許容される塩と同時に、別々に、または連続して組み合わせて使用するための抗ヒトVEGFR-2(配列番号5)抗体を含む医薬組成物であって、前記抗体が、配列番号2のアミノ酸配列を有する重鎖可変領域を有する重鎖および配列番号1のアミノ酸配列を有する軽鎖可変領域を有する軽鎖を含み、前記患者が、前記抗体を10mg/kgで14日周期の1日目に投与され、ならびにオシメルチニブまたはその薬学的に許容される塩を80mgの1日用量で毎日投与される、前記医薬組成物。
- 前記転移性EGFR T790M陽性非小細胞肺癌が、中枢神経系に転移している、請求項1に記載の医薬組成物。
- 配列番号4のアミノ酸配列を有する重鎖および配列番号3のアミノ酸配列を有する軽鎖を含む、請求項1または2に記載の医薬組成物。
- 前記患者が、前記抗体を受ける前に、ゲフィチニブ、エルロチニブ、またはアファチニブによる治療を受けている、請求項1~3のいずれか一項に記載の医薬組成物。
- 前記癌が、エクソン19の欠失およびエクソン21におけるL858R変異からなる群から選択される少なくとも1つのさらなるEGFR活性化変異をさらに含む、請求項1~4のいずれか一項に記載の医薬組成物。
- 前記患者が、オシメルチニブのメシル酸塩を投与される、請求項1~5のいずれか一項に記載の医薬組成物。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2022109875A JP2022133436A (ja) | 2017-08-21 | 2022-07-07 | Egfr阻害剤と抗ヒトvegfr-2抗体との組み合わせ |
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762548069P | 2017-08-21 | 2017-08-21 | |
US62/548,069 | 2017-08-21 | ||
US201862664529P | 2018-04-30 | 2018-04-30 | |
US62/664,529 | 2018-04-30 | ||
US201862672153P | 2018-05-16 | 2018-05-16 | |
US62/672,153 | 2018-05-16 | ||
PCT/US2018/047031 WO2019040348A1 (en) | 2017-08-21 | 2018-08-20 | COMBINATIONS OF EGFR INHIBITORS AND ANTI-VEGFR -2 HUMAN ANTIBODIES |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2022109875A Division JP2022133436A (ja) | 2017-08-21 | 2022-07-07 | Egfr阻害剤と抗ヒトvegfr-2抗体との組み合わせ |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2020530851A JP2020530851A (ja) | 2020-10-29 |
JP2020530851A5 JP2020530851A5 (ja) | 2020-12-10 |
JP7135068B2 true JP7135068B2 (ja) | 2022-09-12 |
Family
ID=63638326
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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JP2020508540A Active JP7135068B2 (ja) | 2017-08-21 | 2018-08-20 | Egfr阻害剤と抗ヒトvegfr-2抗体との組み合わせ |
JP2022109875A Withdrawn JP2022133436A (ja) | 2017-08-21 | 2022-07-07 | Egfr阻害剤と抗ヒトvegfr-2抗体との組み合わせ |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2022109875A Withdrawn JP2022133436A (ja) | 2017-08-21 | 2022-07-07 | Egfr阻害剤と抗ヒトvegfr-2抗体との組み合わせ |
Country Status (4)
Country | Link |
---|---|
US (1) | US11471457B2 (ja) |
EP (1) | EP3672633A1 (ja) |
JP (2) | JP7135068B2 (ja) |
WO (1) | WO2019040348A1 (ja) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CA3148413A1 (en) * | 2019-08-23 | 2021-03-04 | Guru Reddy | Poziotinib combination with vegfr2 inhibitors and methods of use thereof |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2015134242A1 (en) | 2014-03-04 | 2015-09-11 | Eli Lilly And Company | Anti-met in combination with anti-vegfr2 antibodies therapy for cancer |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2003213687A1 (en) | 2002-03-04 | 2003-09-22 | Imclone Systems Incorporated | Human antibodies specific to kdr and uses thereof |
EP3686193B1 (en) | 2011-07-27 | 2022-03-02 | Astrazeneca AB | 2-(2,4,5-substituted-anilino)pyrimidine compounds |
-
2018
- 2018-08-20 WO PCT/US2018/047031 patent/WO2019040348A1/en unknown
- 2018-08-20 EP EP18772972.8A patent/EP3672633A1/en active Pending
- 2018-08-20 US US16/633,230 patent/US11471457B2/en active Active
- 2018-08-20 JP JP2020508540A patent/JP7135068B2/ja active Active
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2022
- 2022-07-07 JP JP2022109875A patent/JP2022133436A/ja not_active Withdrawn
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2015134242A1 (en) | 2014-03-04 | 2015-09-11 | Eli Lilly And Company | Anti-met in combination with anti-vegfr2 antibodies therapy for cancer |
Non-Patent Citations (1)
Title |
---|
Therapeutic Advances in Respiratory Disease,2016年,Vol.10, No.6,p.549-565 |
Also Published As
Publication number | Publication date |
---|---|
US20200155551A1 (en) | 2020-05-21 |
US11471457B2 (en) | 2022-10-18 |
JP2020530851A (ja) | 2020-10-29 |
WO2019040348A1 (en) | 2019-02-28 |
JP2022133436A (ja) | 2022-09-13 |
EP3672633A1 (en) | 2020-07-01 |
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