AU2018303836B2 - Treatment of CD20-positive B-cell lymphoma with obituzumab - Google Patents

Treatment of CD20-positive B-cell lymphoma with obituzumab Download PDF

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Publication number
AU2018303836B2
AU2018303836B2 AU2018303836A AU2018303836A AU2018303836B2 AU 2018303836 B2 AU2018303836 B2 AU 2018303836B2 AU 2018303836 A AU2018303836 A AU 2018303836A AU 2018303836 A AU2018303836 A AU 2018303836A AU 2018303836 B2 AU2018303836 B2 AU 2018303836B2
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AU
Australia
Prior art keywords
obinutuzumab
cycle
administration
hour
speed
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AU2018303836A
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AU2018303836A1 (en
Inventor
Chin-Yu Lin
Mehrdad Mobasher
Michael Wenger
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F Hoffmann La Roche AG
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F Hoffmann La Roche AG
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Application filed by F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Publication of AU2018303836A1 publication Critical patent/AU2018303836A1/en
Application granted granted Critical
Publication of AU2018303836B2 publication Critical patent/AU2018303836B2/en
Priority to AU2025205481A priority Critical patent/AU2025205481A1/en
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • 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
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Oncology (AREA)
  • Hematology (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)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Saccharide Compounds (AREA)
  • Steroid Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2018303836A 2017-10-19 2018-10-19 Treatment of CD20-positive B-cell lymphoma with obituzumab Active AU2018303836B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025205481A AU2025205481A1 (en) 2017-10-19 2025-07-15 Treatment of CD20-positive B-cell lymphoma with obituzumab

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762574297P 2017-10-19 2017-10-19
US62/574,297 2017-10-19
PCT/JP2018/038924 WO2019017499A2 (en) 2017-10-19 2018-10-19 PHARMACEUTICAL COMPOSITION

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2025205481A Division AU2025205481A1 (en) 2017-10-19 2025-07-15 Treatment of CD20-positive B-cell lymphoma with obituzumab

Publications (2)

Publication Number Publication Date
AU2018303836A1 AU2018303836A1 (en) 2020-05-14
AU2018303836B2 true AU2018303836B2 (en) 2025-04-17

Family

ID=64362606

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2018303836A Active AU2018303836B2 (en) 2017-10-19 2018-10-19 Treatment of CD20-positive B-cell lymphoma with obituzumab
AU2025205481A Pending AU2025205481A1 (en) 2017-10-19 2025-07-15 Treatment of CD20-positive B-cell lymphoma with obituzumab

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2025205481A Pending AU2025205481A1 (en) 2017-10-19 2025-07-15 Treatment of CD20-positive B-cell lymphoma with obituzumab

Country Status (14)

Country Link
US (2) US12129304B2 (enExample)
EP (2) EP3697818B1 (enExample)
JP (2) JP6860652B2 (enExample)
KR (2) KR102766089B1 (enExample)
CN (2) CN120983618A (enExample)
AU (2) AU2018303836B2 (enExample)
BR (1) BR112020007731A2 (enExample)
CA (1) CA3079374A1 (enExample)
ES (1) ES3005784T3 (enExample)
IL (2) IL321935A (enExample)
MX (2) MX2020003418A (enExample)
PL (1) PL3697818T3 (enExample)
TW (2) TWI828593B (enExample)
WO (1) WO2019017499A2 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2020003418A (es) * 2017-10-19 2020-07-20 Hoffmann La Roche Tratamiento de linfoma de células b positivo a cd20 con obinutuzumab.
US20240050562A1 (en) * 2019-10-04 2024-02-15 Chugai Seiyaku Kabushiki Kaisha Inhibitor of cell proliferation in obinutuzumab resistant cd20-positive cancer, and medicinal composition, medicine, production, method for inhibiting cell proliferation, therapeutic method, type ii anti-cd20 antibody, compounds, combination of same, enhancer and inducer, each relating thereto
JPWO2023042679A1 (enExample) 2021-09-17 2023-03-23

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016024228A1 (en) * 2014-08-11 2016-02-18 Acerta Pharma B.V. Therapeutic combinations of a btk inhibitor, a pi3k inhibitor, a jak-2 inhibitor, a pd-1 inhibitor and/or a pd-l1 inhibitor

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ME01775B (me) 2003-11-05 2011-02-28 Glycart Biotechnology Ag Cd20 antitijela sa povećanim afinitetom vezivanja za fc receptor i efektornom funkcijom
NZ585516A (en) 2007-12-21 2012-07-27 Hoffmann La Roche Anti-cd20 antibody formulation
US11149091B2 (en) * 2015-12-09 2021-10-19 Cedars-Sinai Medical Center Methods for treating nephrotic syndrome
CN108395482B (zh) 2017-02-08 2021-02-05 西比曼生物科技(香港)有限公司 一种靶向cd20抗原嵌合抗原受体的构建及其工程化t细胞的活性鉴定
JP6881583B2 (ja) 2017-07-21 2021-06-02 横浜ゴム株式会社 空気入りタイヤ
MX2020003418A (es) * 2017-10-19 2020-07-20 Hoffmann La Roche Tratamiento de linfoma de células b positivo a cd20 con obinutuzumab.

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016024228A1 (en) * 2014-08-11 2016-02-18 Acerta Pharma B.V. Therapeutic combinations of a btk inhibitor, a pi3k inhibitor, a jak-2 inhibitor, a pd-1 inhibitor and/or a pd-l1 inhibitor

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
Cartron, G. et al., "Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study", Blood 2014; 124 (14): 2196–2202. doi: https://doi.org/10.1182/blood-2014-07-586610 *
FDA, HIGHLIGHTS OF PRESCRIBING INFORMATION (GAYZVA), 2014 (Year: 2014) *
Tobinai, K. et al., (2017). A Review of Obinutuzumab (GA101), a Novel Type II Anti-CD20 Monoclonal Antibody, for the Treatment of Patients with B-Cell Malignancies. Advances in therapy, 34(2), 324–356. *
Tsujimura, H. et al., "Safety and Tolerability of Obinutuzumab (GA101) with Shorter Duration of Infusion in Japanese Patients with Previously Untreated CD20-Positive B-Cell Non-Hodgkin's Lymphomas...", Blood 2016; 128 (22): 5389 *

Also Published As

Publication number Publication date
IL321935A (en) 2025-09-01
US20200299398A1 (en) 2020-09-24
US12129304B2 (en) 2024-10-29
IL273909B2 (en) 2025-12-01
JP6860652B2 (ja) 2021-04-21
MX2024009217A (es) 2024-11-08
AU2018303836A1 (en) 2020-05-14
KR20240157135A (ko) 2024-10-31
BR112020007731A2 (pt) 2020-10-20
JP2019528282A (ja) 2019-10-10
PL3697818T3 (pl) 2025-03-24
EP3697818B1 (en) 2024-11-27
AU2025205481A1 (en) 2025-08-07
US20250026847A1 (en) 2025-01-23
TW202342099A (zh) 2023-11-01
TW201922284A (zh) 2019-06-16
IL273909B1 (en) 2025-08-01
WO2019017499A2 (en) 2019-01-24
EP4520347A3 (en) 2025-06-04
MX2020003418A (es) 2020-07-20
IL273909A (en) 2020-05-31
CA3079374A1 (en) 2019-01-24
JP2021152002A (ja) 2021-09-30
EP3697818A2 (en) 2020-08-26
WO2019017499A3 (en) 2019-02-21
CN120983618A (zh) 2025-11-21
TWI805630B (zh) 2023-06-21
CN111212854A (zh) 2020-05-29
KR102766089B1 (ko) 2025-02-13
ES3005784T3 (en) 2025-03-17
JP7370357B2 (ja) 2023-10-27
EP4520347A2 (en) 2025-03-12
KR20200067196A (ko) 2020-06-11
TWI828593B (zh) 2024-01-01

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