DK2632954T3 - Midler og fremgangsmåder til behandling af dlbcl - Google Patents

Midler og fremgangsmåder til behandling af dlbcl Download PDF

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Publication number
DK2632954T3
DK2632954T3 DK11787633.4T DK11787633T DK2632954T3 DK 2632954 T3 DK2632954 T3 DK 2632954T3 DK 11787633 T DK11787633 T DK 11787633T DK 2632954 T3 DK2632954 T3 DK 2632954T3
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dose
composition
dlbcl
antibody
use according
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DK11787633.4T
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DK2632954T4 (da
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Gerhard Zugmaier
Dirk Nagorsen
Juergen Scheele
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Amgen Res Munich Gmbh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Oncology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Steroid Compounds (AREA)
  • Carbon And Carbon Compounds (AREA)

Claims (18)

  1. MIDLER OG FREMGANGSMÅDER TIL BEHANDLING AF DLBCL Patentkrav
    1. Sammensætning, som omfatter et CD19xCD3-bispecifikt antistof til anvendelse ved en fremgangsmåde til behandling af tumormasse i lymfeknudevæv og/eller ekstranodalt lymfom forårsaget af diffust storcellet B-cellelymfom (DLBCL) hos en patient, hvor fremgangsmåden endvidere omfatter administration af mindst ét glucocorticoid.
  2. 2. Sammensætning til anvendelsen ifølge krav 1, hvor tumormassen er kendetegnet ved tumorer med en størrelse på mere end 10 x 10 mm.
  3. 3. Sammensætning til anvendelsen ifølge krav 1 eller 2, hvor lymfeknudevævet indbefatter lymfeknuder og/eller milt.
  4. 4. Sammensætning til anvendelsen ifølge krav 1 eller 2, hvor det ekstranodale lymfom indbefatter centralnervesystemet (CNS), hudvæv, bryst, lungerne, leveren, mave-tarm-kanalen, urogenitalkanalen, øjenvæv, knoglemarv og/eller knogler.
  5. 5. Sammensætning til anvendelsen ifølge et hvilket som helst af de foregående krav, hvor en første dosis af sammensætningen administreres i et første tidsrum, og en anden dosis af sammensætningen efterfølgende administreres i et andet tidsrum, hvor den anden dosis er større end den første dosis.
  6. 6. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor den første dosis er på mellem 1 og 15 pg/m2/d.
  7. 7. Sammensætning til anvendelse ifølge et hvilket som helst af de foregående krav, hvor den anden dosis er på mellem 15 og 60 pg/m2/d.
  8. 8. Sammensætning til anvendelsen ifølge krav 5, hvilken anvendelse endvidere, efter administration af en første og en anden dosis i et første og et andet tidsrum, omfatter administration af en tredje dosis af sammensætningen i et tredje tidsrum.
  9. 9. Sammensætning til anvendelsen ifølge krav 8, hvor det tredje tidsrum er længere end det første og det andet tidsrum, hvorved den anden dosis er større end den første dosis.
  10. 10. Sammensætning til anvendelsen ifølge krav 8 eller 9, hvor den tredje dosis er større end den første og den anden dosis.
  11. 11. Sammensætning til anvendelsen ifølge et hvilket som helst af kravene 8-10, hvor den første dosis er på mellem 1 og 15 pg/m2/d, idet 5 pg/m2/d foretrækkes.
  12. 12. Sammensætning til anvendelsen ifølge et hvilket som helst af kravene 8-11, hvor den anden dosis er på mellem 1 og 15 pg/m2/d, idet 15 pg/m2/d foretrækkes.
  13. 13. Sammensætning til anvendelsen ifølge et hvilket som helst af kravene 8-12, hvor den tredje dosis er på mellem 15 og 60 pg/m2/d, idet 60 pg/m2/d foretrækkes.
  14. 14. Sammensætning til anvendelsen ifølge et hvilket som helst af kravene 1-4, hvor antistoffet under behandling doseres med en konstant dosis valgt fra gruppen bestående af 5 pg/m2/d, 15 pg/m2/d og 60 pg/m2/d, idet 60 pg/m2/d foretrækkes.
  15. 15. Sammensætning til anvendelsen ifølge krav 1, hvor glucocorticoidet er valgt fra gruppen bestående af mindst én af cortison, cortisol, cloprednol, prednison, prednisolon, methylprednisolon, deflazacort, fluocortolon, triamcinolon, dexamethason, og betamethason, flusticasonpropionat, triamcinolonacetonid, idet dexamethason foretrækkes.
  16. 16. Sammensætning til anvendelse ifølge krav 15, hvor glucocorticoidet administreres inden administrationen af det CD19xCD3-bispecifikke antistof.
  17. 17. Sammensætning til anvendelse ifølge krav 16, hvor glucocorticoidet administreres mellem 6 og 48 timer inden administrationen af det CD19xCD3-bispecifikke antistof, fortrinsvis mellem 6 og 12 timer.
  18. 18. Sammensætning til anvendelsen ifølge krav 1, hvor patienten er behandlingsrefraktær over for kemoterapi eller eksperimentel kemoterapi og/eller har recidiv efter behandling med kemoterapi eller eksperimentel kemoterapi.
DK11787633.4T 2010-10-27 2011-10-27 Midler og fremgangsmåder til behandling af dlbcl DK2632954T4 (da)

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US40710710P 2010-10-27 2010-10-27
PCT/EP2011/068851 WO2012055961A1 (en) 2010-10-27 2011-10-27 Means and methods for treating dlbcl

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DK2632954T3 true DK2632954T3 (da) 2016-02-01
DK2632954T4 DK2632954T4 (da) 2021-08-09

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DK18164175.4T DK3412687T3 (da) 2010-10-27 2011-10-27 Fremgangsmåder til behandling af dlbcl
DK11787633.4T DK2632954T4 (da) 2010-10-27 2011-10-27 Midler og fremgangsmåder til behandling af dlbcl
DK15195076.3T DK3018145T3 (da) 2010-10-27 2011-10-27 Midler og fremgangsmåder til behandling af dlbcl

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EP (3) EP3412687B1 (da)
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KR (1) KR101889995B1 (da)
CN (2) CN103459425B (da)
AU (1) AU2011322581B2 (da)
CA (1) CA2815119C (da)
CL (1) CL2013001138A1 (da)
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EA (1) EA032139B1 (da)
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HR (2) HRP20151444T4 (da)
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CR20130245A (es) 2013-09-20
AU2011322581A1 (en) 2013-05-09
CN103459425A (zh) 2013-12-18
US10696744B2 (en) 2020-06-30
PL2632954T3 (pl) 2016-05-31
PT3018145T (pt) 2018-05-17
PT3412687T (pt) 2020-04-03
PH12013500826A1 (en) 2013-06-17
LT3018145T (lt) 2018-05-10
US20160208001A1 (en) 2016-07-21
US9192665B2 (en) 2015-11-24
SI3018145T1 (en) 2018-08-31
EP3018145A1 (en) 2016-05-11
TR201808019T4 (tr) 2018-06-21
HRP20151444T4 (hr) 2021-08-20
HUE037786T2 (hu) 2018-09-28
CY1117155T1 (el) 2017-04-05
EP2632954A1 (en) 2013-09-04
PL3018145T3 (pl) 2018-09-28
JP5997168B2 (ja) 2016-09-28
EP2632954B1 (en) 2015-11-25
CN103459425B (zh) 2015-11-25
SI2632954T2 (sl) 2021-11-30
NZ719768A (en) 2021-07-30
PT2632954E (pt) 2016-02-03
JP6254220B2 (ja) 2017-12-27
MY163057A (en) 2017-08-15
CA2815119C (en) 2023-01-10
IL225924A0 (en) 2013-06-27
SI2632954T1 (sl) 2016-02-29
SMT201800319T1 (it) 2018-07-17
MA34619B1 (fr) 2013-10-02
IL256110A (en) 2018-02-28
SMT201600050B (it) 2016-04-29
CA2815119A1 (en) 2012-05-03
IL225924A (en) 2017-12-31
NZ609201A (en) 2015-01-30
WO2012055961A1 (en) 2012-05-03
DK2632954T4 (da) 2021-08-09
SI3412687T1 (sl) 2020-07-31
ES2675299T3 (es) 2018-07-10
ES2563439T3 (es) 2016-03-15
JP2013540799A (ja) 2013-11-07
US20130287778A1 (en) 2013-10-31
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UA111175C2 (uk) 2016-04-11
EP2632954B2 (en) 2021-07-07
CN105251003B (zh) 2019-08-02
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