HRP20211478T1 - Imunoterapijski režimi doziranja koji obuhvaćaju pomalidomid i anti-cs1 antitijelo za liječenje raka - Google Patents

Imunoterapijski režimi doziranja koji obuhvaćaju pomalidomid i anti-cs1 antitijelo za liječenje raka Download PDF

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Publication number
HRP20211478T1
HRP20211478T1 HRP20211478TT HRP20211478T HRP20211478T1 HR P20211478 T1 HRP20211478 T1 HR P20211478T1 HR P20211478T T HRP20211478T T HR P20211478TT HR P20211478 T HRP20211478 T HR P20211478T HR P20211478 T1 HRP20211478 T1 HR P20211478T1
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HR
Croatia
Prior art keywords
dose
administered
days
elotuzumab
orally
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HRP20211478TT
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English (en)
Inventor
Christopher Lee MULLIGAN
Justin Blake Bartlett
Michael Darron ROBBINS
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Bristol-Myers Squibb Company
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Publication of HRP20211478T1 publication Critical patent/HRP20211478T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • C07K16/2803Immunoglobulins [IGs], 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
    • 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
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Claims (11)

1. Kombinirani terapijski režim u kome se svaka komponenta navedene kombinacije zasebno administrira, koji obuhvaća: (i) terapijski efikasnu količinu pomalidomida; (ii) terapijski efikasnu količinu elotuzumaba, i (iii) terapijski prihvatljivu količinu deksametazona, za primjenu u postupku liječenja pacijenta sa multiplim mijelomom koji je napredovao nakon primanja inicijalnog tretmana, pri čemu navedena kombinacija zaustavlja navedenu progresiju i efikasno liječi multipli mijelom navedenog pacijenta.
2. Kombinirani terapijski režim za primjenu iz patentnog zahtjeva 1, pri čemu je početno liječenje liječenje lenalidomidom.
3. Kombinirani terapijski režim u kome se svaka komponenta navedene kombinacije zasebno administrira, koji obuhvaća: (i) terapijski efikasnu količinu pomalidomida; (ii) terapijski efikasnu količinu elotuzumaba, i (iii) terapijski prihvatljivu količinu deksametazona, za primjenu u postupku liječenja pacijenta sa multiplim mijelomom koji je rezistentan na lenalidomid, pri čemu navedena kombinacija nadilazi rezistentnost navedenog pacijenta na lenalidomid i efikasno liječi multipli mijelom navedenog pacijenta.
4. Kombinirani terapijski režim za primjenu prema bilo kojem od patentnih zahtjeva 1 do 3, pri čemu se pomalidomid administrira u dozi od 4 mg, elotuzumab se administrira u dozi od 10 mg/kg, i deksametazon se administrira bilo oralno u dozi od 28 mg do 40 mg, ili putem IV u dozi od 8 mg.
5. Kombinirani terapijski režim za primjenu prema bilo kojem od patentnih zahtjeva 1 do 3, pri čemu se pomalidomid administrira u dozi od 4 mg na dan tokom 21 dana, elotuzumab se administrira u dozi od 10 mg/kg tjedno, i deksametazon se administrira bilo oralno u dozi od 28 mg do 40 mg na dan tokom 21 dana, ili putem IV u dozi od 8 mg tjedno.
6. Kombinirani terapijski režim za primjenu prema bilo kojem od patentnih zahtjeva 1 do 3, pri čemu (i) pomalidomid se administrira u dozi od 4 mg oralno 1-21. dana svakog ciklusa, (ii) elotuzumab se administrira u dozi od 10 mg/kg intravenski (IV) 1, 8, 15. i 22. dana ciklusa 1 i 2, a potom se administrira u dozi od 20 mg/kg IV 1. dana ciklusa 3 i nakon, i (iii) deksametazon se administrira u dozi od 28 mg oralno i 8 mg IV na dane doziranja elotuzumaba (1, 8,15. i 22. dan ciklusa 1 i 2 i 1. dan ciklusa 3 i nakon), i u dozi od 40 mg oralno po tjednu, tjedno bez doziranja elotuzumaba kod subjekata ≤ 75 godina starosti, i administrira u dozi od 8 mg oralno i 8 mg IV na dane kad se dozira elotuzumab (1, 8, 15. i 22. dan ciklusa 1 i 2 i 1. dana ciklusa 3 i nakon), i u dozi od 20 mg oralno po tjednu, tjednom bez doziranja elotuzumaba kod subjekata > 75 godina starosti, pri čemu se ciklus definira kao 28 dana.
7. Kombinirani terapijski režim u kome se svaka komponenta navedene kombinacije zasebno administrira, koji obuhvaća: (i) terapijski efikasnu količinu pomalidomida; (ii) terapijski efikasnu količinu elotuzumaba, i (iii) terapijski prihvatljivu količinu deksametazona, za primjenu u metodi za liječenje pacijenta sa multiplim mijelomom, pri čemu navedena kombinacija efikasno liječi multipli mijelom navedenog pacijenta.
8. Kombinirani terapijski režim za primjenu iz patentnog zahtjeva 7, pri čemu se pomalidomid administrira u dozi od 4 mg, elotuzumab se administrira u dozi od 10 mg/kg, i deksametazon se administrira bilo oralno u dozi od 28 mg do 40 mg, ili putem IV u dozi od 8 mg.
9. Kombinirani terapijski režim za primjenu iz patentnog zahtjeva 7, pri čemu se pomalidomid administrira u dozi od 4 mg na dan tokom 21 dana, elotuzumab se administrira u dozi od 10 mg/kg tjedno, i deksametazon se administrira bilo oralno u dozi od 28 mg do 40 mg na dan tokom 21 dana, ili putem IV u dozi od 8 mg tjedno u ukupnom ciklusu doziranja od 28 dana, i po izboru gdje se elotuzumab administrira u dozi od 20 mg/kg u naknadnim ciklusima doziranja koji nisu prvi i drugi ciklus.
10. Kombinirani terapijski režim za primjenu iz patentnog zahtjeva 7, pri čemu (i) pomalidomid se administrira u dozi od 4 mg oralno 1-21. dana svakog ciklusa, (ii) elotuzumab se administrira u dozi od 10 mg/kg intravenski (IV) 1, 8, 15. i 22. dana ciklusa 1 i 2, a potom administrira u dozi od 20 mg/kg IV 1. dana ciklusa 3 i nakon, i (iii) deksametazon se administrira u dozi od 28 mg oralno i 8 mg IV danima kad se dozira elotuzumab (1, 8,15. i 22. dan ciklusa 1 i 2 i 1. dan ciklusa 3 i nakon), i u dozi od 40 mg oralno po tjednu, tjedno bez doziranja elotuzumaba kod subjekata ≤ 75 godina starosti, i administrira se u dozi od 8 mg oralno i 8 mg IV danima kada se dozira (1, 8, 15. i 22. dan ciklusa 1 i 2 i 1. dan ciklusa 3 i nakon), i u dozi od 20 mg oralno po tjednu, tjedno bez doziranja elotuzumaba kod subjekata > 75 godina starosti, pri čemu se ciklus definira kao 28 dana.
11. Kombinirani terapijski režim za primjenu prema bilo kojem od patentnih zahtjeva 1 do 10, pri čemu navedena kombinacija dovodi do sinergističkog smanjenja opterećenja tumorom, regresije tumora, razvoja tumora, smanjenja nivoa M-proteina, plazma stanica i/ili regresije spomenutog raka.
HRP20211478TT 2015-06-29 2016-06-28 Imunoterapijski režimi doziranja koji obuhvaćaju pomalidomid i anti-cs1 antitijelo za liječenje raka HRP20211478T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562185968P 2015-06-29 2015-06-29
US201562239965P 2015-10-11 2015-10-11
US201562262574P 2015-12-03 2015-12-03
PCT/US2016/039723 WO2017003990A1 (en) 2015-06-29 2016-06-28 Immunotherapeutic dosing regimens comprising pomalidomide and an anti-cs1 antibody for treating cancer
EP16738609.3A EP3313528B1 (en) 2015-06-29 2016-06-28 Immunotherapeutic dosing regimens comprising pomalidomide and an anti-cs1 antibody for treating cancer

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HRP20211478T1 true HRP20211478T1 (hr) 2021-12-24

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HRP20211478TT HRP20211478T1 (hr) 2015-06-29 2016-06-28 Imunoterapijski režimi doziranja koji obuhvaćaju pomalidomid i anti-cs1 antitijelo za liječenje raka

Country Status (19)

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US (2) US10925867B2 (hr)
EP (2) EP3313528B1 (hr)
JP (1) JP6754785B2 (hr)
CN (1) CN107949425A (hr)
BR (1) BR112017027692A2 (hr)
CA (1) CA2990478A1 (hr)
CY (1) CY1124543T1 (hr)
DK (1) DK3313528T3 (hr)
EA (1) EA035888B1 (hr)
ES (1) ES2886657T3 (hr)
HR (1) HRP20211478T1 (hr)
HU (1) HUE056491T2 (hr)
LT (1) LT3313528T (hr)
MX (1) MX2017015765A (hr)
PL (1) PL3313528T3 (hr)
PT (1) PT3313528T (hr)
RS (1) RS62352B1 (hr)
SI (1) SI3313528T1 (hr)
WO (1) WO2017003990A1 (hr)

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RS62352B1 (sr) * 2015-06-29 2021-10-29 Bristol Myers Squibb Co Imunoterapijski režimi doziranja koji obuhvataju pomalidomid i anti-cs1 antitelo za lečenje kancera

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Publication number Publication date
US20210154183A1 (en) 2021-05-27
US10925867B2 (en) 2021-02-23
WO2017003990A1 (en) 2017-01-05
SI3313528T1 (sl) 2021-11-30
CY1124543T1 (el) 2022-07-22
EP3313528A1 (en) 2018-05-02
BR112017027692A2 (pt) 2018-10-09
CA2990478A1 (en) 2017-01-05
CN107949425A (zh) 2018-04-20
HUE056491T2 (hu) 2022-02-28
US20180185348A1 (en) 2018-07-05
EP3950065A1 (en) 2022-02-09
MX2017015765A (es) 2018-04-13
LT3313528T (lt) 2021-10-11
JP6754785B2 (ja) 2020-09-16
EP3313528B1 (en) 2021-08-04
ES2886657T3 (es) 2021-12-20
RS62352B1 (sr) 2021-10-29
JP2018522881A (ja) 2018-08-16
PL3313528T3 (pl) 2021-12-13
PT3313528T (pt) 2021-09-16
EA201890035A1 (ru) 2018-06-29
EA035888B1 (ru) 2020-08-27
DK3313528T3 (da) 2021-09-20

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