Method of treating multiple myeloma using combination therapies based on anti-cs1 antibodies

Patent metadata

Field	Value
Publication number	US-2016137735-A1
Application number	US-201514834077-A
Country	US
Kind code	A1
Filing date	Aug 24, 2015
Priority date	Aug 7, 2006
Publication date	May 19, 2016
Grant date	—

Abstract

Compositions and methods for treating MM are provided herein.

First claim

1 - 63 . (canceled)

64 . A method of treating multiple myeloma in a subject, comprising administering to a subject in need thereof a first pharmaceutical composition comprising a therapeutically effective amount of an anti-CS1 antibody and a second pharmaceutical composition comprising a therapeutically effective amount of lenalidomide.

65 . The method of claim 64 , wherein the anti-CS1 antibody binds the epitope covered by amino acids 170 to 227 of SEQ ID NO:1.

66 . The method of claim 64 , wherein the anti-CS1 antibody binds the epitope covered by amino acids 23 to 151 of SEQ ID NO:1 or the epitope covered by amino acids 68 to 151 of SEQ ID NO:1.

67 . The method of claim 64 , wherein the anti-CS1 antibody is a humanized IgG 1 antibody comprising the heavy chain variable region of SEQ ID NO:5 and the light chain variable region of SEQ ID NO:6.

68 . A method of treating multiple myeloma in a subject, the method comprising administering to a subject in need thereof (a) an anti-CS1 antibody that binds the epitope cluster covered by amino acids 170 to 227 of SEQ ID NO:1, and (b) two more therapeutic agents, wherein said two more therapeutic agents consist of dexamethasone and bortezomib.

69 . The method of claim 68 , wherein the anti-CS1 antibody, the dexamethasone and the bortezomib are provided in three separate pharmaceutical compositions.

70 . The method of claim 69 , wherein the three pharmaceutical compositions are administered separately or concurrently.

71 . The method of claim 70 , wherein the three pharmaceutical compositions are administered separately.

72 . The method of claim 69 , wherein the anti-CS1 antibody is a humanized IgG 1 antibody comprising the heavy chain variable region of SEQ ID NO:5 and the light chain variable region of SEQ ID NO:6.

73 . The method of claim 72 , in which the anti-CS1 antibody is administered intravenously at a dose from approximately 0.5 mg/kg to approximately 20 mg/kg.

74 . The method of claim 72 , in which the anti-CS1 antibody is administered intravenously at a dose of approximately 10 mg/kg.

75 . The method of claim 72 , wherein the bortezomib is administered twice weekly over a 21 day cycle followed by a 10 day rest period.

76 . The method of claim 72 , wherein the anti-CS1 antibody administered once every 10 days.

77 . The method of claim 72 , wherein the anti-CS1 antibody is administered as an intravenous infusion at a dose from 2.5 mg/kg to 20 mg/kg and wherein the bortezomib is administered as an intravenous infusion at a dose from 0.2 mg/m 2 to 2.0 mg/m 2 .

78 . The method of claim 77 , wherein the bortezomib is administered at an intravenous dose from 1.0 mg/m 2 to 1.3 mg/m 2 .

79 . The method of claim 78 , wherein the bortezomib is administered at an intravenous dose of 1.0 mg/m 2 .

80 . The method of claim 78 , wherein the bortezomib is administered at an intravenous dose of 1.3 mg/m 2 .

81 . The method of claim 77 , wherein the anti-CS1 antibody is administered at an intravenous dose of 2.5 mg/kg.

82 . The method of claim 77 , wherein the anti-CS1 antibody is administered at an intravenous dose of 5 mg/kg.

83 . The method of claim 77 , wherein the anti-CS1 antibody is administered at an intravenous dose of 10 mg/kg.

84 . The method of claim 77 , wherein the patient receives the anti-CS1 antibody once every 10 days.

85 . The method of claim 84 , wherein the patient receives the bortezomib four times in a three week cycle.

86 . The method of claim 85 , wherein the bortezomib is given on days 1, 4, 8, and 11 followed by a 10 day rest period.

87 . A method of treating multiple myeloma in a subject concurrently on a regimen of two therapeutic agents that consist of dexamethasone and bortezomib, comprising administering a therapeutically effective amount of an anti-CS1 antibody that binds the epitope cluster covered by amino acids 170 to 227 of SEQ ID NO:1 to the subject.

88 . The method of claim 87 , wherein the anti-CS1 antibody is a humanized IgG 1 antibody comprising the heavy chain variable region of SEQ ID NO:5 and the light chain variable region of SEQ ID NO:6.

89 . The method of claim 88 , in which the anti-CS1 antibody is administered intravenously at a dose from approximately 0.5 mg/kg to approximately 20 mg/kg.

90 . The method of claim 88 , in which the anti-CS1 antibody is administered intravenously at a dose of approximately 10 mg/kg.

91 . The method of claim 88 , wherein the bortezomib is administered twice weekly over a 21 day cycle followed by a 10 day rest period.

92 . The method of claim 88 , wherein the anti-CS1 antibody is administered as an intravenous infusion at a dose from 2.5 mg/kg to 20 mg/kg and wherein the bortezomib is administered as an intravenous infusion at a dose from 0.2 mg/m 2 to 2.0 mg/m 2 .

93 . The method of claim 92 , wherein the bortezomib is administered at an intravenous dose from 1.0 mg/m 2 to 1.3 mg/m 2 .

94 . The method of claim 93 , wherein the bortezomib is administered at an intravenous dose of 1.0 mg/m 2 .

95 . The method of claim 93 , wherein the bortezomib is administered at an intravenous dose of 1.3 mg/m 2 .

96 . The method of claim 92 , wherein the anti-CS1 antibody is administered at an intravenous dose of 2.5 mg/kg.

97 . The method of claim 92 , wherein the anti-CS1 antibody is administered at an intravenous dose of 5 mg/kg.

98 . The method of claim 92 , wherein the anti-CS1 antibody is administered at an intravenous dose of 10 mg/kg.

99 . The method of claim 92 , wherein the patient receives the anti-CS1 antibody once every 10 days.

100 . The method of claim 99 , wherein the patient receives the bortezomib four times in a three week cycle.

101 . The method of claim 100 , wherein the bortezomib is given on days 1, 4, 8, and 11 followed by a 10 day rest period.

Assignees

• Abbvie Biotherapeutics Inc
• Dana Farber Cancer Insitute Inc

Inventors

• Afar Daniel
• Anderson Kenneth C
• Tai Yu-Tzu

Classifications

• A61P35/02

  specific for leukemia · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K31/69

  Boron compounds · CPC title

• C07K2317/732

  Antibody-dependent cellular cytotoxicity [ADCC] · CPC title