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US 2021/0171653 A1Published application
Use of isatuximab for the treatment of relapsed and/or refractory multiple myeloma
AssigneesSanofi-Aventis U.S. LLC, Sanofi
InventorsMarie-Laure RISSE, Gaelle ASSET
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Abstract
The present disclosure provides methods for treating multiple myeloma (such as refractory multiple myeloma or relapsed and refractory multiple myeloma) in an individual who received one to three prior therapies (or prior lines of therapy) for multiple myeloma. The methods comprise administering to the individual an anti-CD38 antibody, carfilzomib, and dexamethasone.
Claims24
An anti-CD38 antibody comprising (a) a heavy chain variable domain (VH) that comprises:
- a CDR-H1 comprising the amino acid sequence DYWMQ (SEQ ID NO:
- 1), a CDR-H2 comprising the amino acid sequence TIYPGDGDTGYAQKFQG (SEQ ID NO:
- 2), and a CDR-H3 comprising the amino acid sequence GDYYGSNSLDY (SEQ ID NO:
- 3), and (b) a light chain variable domain (VL) that comprises:
- a CDR-L1 comprising the amino acid sequence KASQDVSTVVA (SEQ ID NO:
- 4), a CDR-L2 comprising the amino acid sequence SASYRYI (SEQ ID NO:
- 5), and a CDR-L3 comprising the amino acid sequence QQHYSPPYT (SEQ ID NO:
- 6) for use in a method of treating multiple myeloma in an individual, the method comprising administering the anti-CD38 antibody, carfilzomib, and dexamethasone to the individual,
- wherein the anti-CD38 antibody is administered at a dose of 10 mg/kg, the carfilzomib is administered at a dose of 20 mg/m2 or 56 mg/m2, and the dexamethasone is administered at a dose of 20 mg,
- wherein the individual received at least one prior therapy for multiple myeloma, and wherein the treatment extends progression free survival (PFS) and/or overall survival (OS) of the individual.
7 more elements
An anti-CD38 antibody comprising (a) a heavy chain variable domain (VH) that comprises:
- a CDR-H1 comprising the amino acid sequence DYWMQ (SEQ ID NO:
- 1), a CDR-H2 comprising the amino acid sequence TIYPGDGDTGYAQKFQG (SEQ ID NO:
- 2), and a CDR-H3 comprising the amino acid sequence GDYYGSNSLDY (SEQ ID NO:
- 3), and (b) a light chain variable domain (VL) that comprises:
- a CDR-L1 comprising the amino acid sequence KASQDVSTVVA (SEQ ID NO:
- 4), a CDR-L2 comprising the amino acid sequence SASYRYI (SEQ ID NO:
- 5), and a CDR-L3 comprising the amino acid sequence QQHYSPPYT (SEQ ID NO:
- 6) for use in a method of treating multiple myeloma in an individual, the method comprising the method comprising administering the anti-CD38 antibody, carfilzomib, and dexamethasone to the individual,
- wherein the anti-CD38 antibody is administered at a dose of 10 mg/kg, the carfilzomib is administered at a dose of 20 mg/m2 or 56 mg/m2, and the dexamethasone is administered at a dose of 20 mg,
- wherein the individual received at least one prior therapy for multiple myeloma, and
- wherein the individual is Minimal Residual Disease negative at a threshold of 10−5 or less after treatment.
8 more elements
An anti-CD38 antibody comprising (a) a heavy chain variable domain (VH) that comprises:
- a CDR-H1 comprising the amino acid sequence DYWMQ (SEQ ID NO:
- 1), a CDR-H2 comprising the amino acid sequence TIYPGDGDTGYAQKFQG (SEQ ID NO:
- 2), and a CDR-H3 comprising the amino acid sequence GDYYGSNSLDY (SEQ ID NO:
- 3), and (b) a light chain variable domain (VL) that comprises:
- a CDR-L1 comprising the amino acid sequence KASQDVSTVVA (SEQ ID NO:
- 4), a CDR-L2 comprising the amino acid sequence SASYRYI (SEQ ID NO:
- 5), and a CDR-L3 comprising the amino acid sequence QQHYSPPYT (SEQ ID NO:
- 6) for use in a method of treating multiple myeloma in an individual, the method comprising administering the anti-CD38 antibody, carfilzomib and dexamethasone to the individual,
- wherein the anti-CD38 antibody is administered at a dose of 10 mg/kg, the carfilzomib is administered at a dose of 20 mg/m2 or 56 mg/m2, and the dexamethasone is administered at a dose of 20 mg,
- wherein the individual received at least one prior therapy for multiple myeloma, and
- wherein the individual has renal impairment at the start of treatment.
8 more elements
A method of treating a human individual having multiple myeloma, comprising administering to the individual an anti-CD38 antibody comprising (a) a heavy chain variable domain (VH) that comprises:
- a CDR-H1 comprising the amino acid sequence DYWMQ (SEQ ID NO:
- 1), a CDR-H2 comprising the amino acid sequence TIYPGDGDTGYAQKFQG (SEQ ID NO:
- 2), and a CDR-H3 comprising the amino acid sequence GDYYGSNSLDY (SEQ ID NO:
- 3), and (b) a light chain variable domain (VL) that comprises:
- a CDR-L1 comprising the amino acid sequence KASQDVSTVVA (SEQ ID NO:
- 4), a CDR-L2 comprising the amino acid sequence SASYRYI (SEQ ID NO:
- 5), and a CDR-L3 comprising the amino acid sequence QQHYSPPYT (SEQ ID NO:
- 6), carfilzomib, and dexamethasone,
- wherein the anti-CD38 antibody is administered at a dose of 10 mg/kg, the carfilzomib is administered at a dose of 20 mg/m2 or 56 mg/m2, and the dexamethasone is administered at a dose of 20 mg,
- wherein the individual received at least one prior therapy for multiple myeloma, and
- wherein the treatment extends progression free survival (PFS) of the individual.
8 more elements
A method of treating a human individual having multiple myeloma, comprising administering to the individual an anti-CD38 antibody comprising (a) a heavy chain variable domain (VH) that comprises:
- a CDR-H1 comprising the amino acid sequence DYWMQ (SEQ ID NO:
- 1), a CDR-H2 comprising the amino acid sequence TIYPGDGDTGYAQKFQG (SEQ ID NO:
- 2), and a CDR-H3 comprising the amino acid sequence GDYYGSNSLDY (SEQ ID NO:
- 3), and (b) a light chain variable domain (VL) that comprises:
- a CDR-L1 comprising the amino acid sequence KASQDVSTVVA (SEQ ID NO:
- 4), a CDR-L2 comprising the amino acid sequence SASYRYI (SEQ ID NO:
- 5), and a CDR-L3 comprising the amino acid sequence QQHYSPPYT (SEQ ID NO:
- 6), carfilzomib, and dexamethasone,
- wherein the anti-CD38 antibody is administered at a dose of 10 mg/kg, the carfilzomib is administered at a dose of 20 mg/m2 or 56 mg/m2, and the dexamethasone is administered at a dose of 20 mg,
- wherein the individual received at least one prior therapy for multiple myeloma, and
- wherein the treatment extends overall survival (OS) of the individual.
8 more elements
A method of treating a human individual having multiple myeloma, comprising administering to the individual an anti-CD38 antibody comprising (a) a heavy chain variable domain (VH) that comprises:
- a CDR-H1 comprising the amino acid sequence DYWMQ (SEQ ID NO:
- 1), a CDR-H2 comprising the amino acid sequence TIYPGDGDTGYAQKFQG (SEQ ID NO:
- 2), and a CDR-H3 comprising the amino acid sequence GDYYGSNSLDY (SEQ ID NO:
- 3), and (b) a light chain variable domain (VL) that comprises:
- a CDR-L1 comprising the amino acid sequence KASQDVSTVVA (SEQ ID NO:
- 4), a CDR-L2 comprising the amino acid sequence SASYRYI (SEQ ID NO:
- 5), and a CDR-L3 comprising the amino acid sequence QQHYSPPYT (SEQ ID NO:
- 6), carfilzomib, and dexamethasone,
- wherein the anti-CD38 antibody is administered at a dose of 10 mg/kg, the carfilzomib is administered at a dose of 20 mg/m2 or 56 mg/m2, and the dexamethasone is administered at a dose of 20 mg,
- wherein the individual received at least one prior therapy for multiple myeloma, and
- wherein the individual is Minimal Residual Disease negative at a threshold of 10−5 or less after treatment.
8 more elements
Dependencies are inferred from the claim text.