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US 11,685,787 B2Granted
Treatment of cancer with anti-GITR agonist antibodies
AssigneeBristol-Myers Squibb Company
InventorsSuba Krishnan, Penny E. Phillips, Zheng Yang, Haiqing Wang
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Abstract
Provided herein are methods for treating cancer, comprising administering to a subject having cancer a therapeutically effective amount of an anti-GITR antibody alone or together with an anti-PD-1 or anti-PD-L1 antibody.
Claims19
A method of treating a human subject having an advanced solid cancer, comprising
- (a) administering to the subject a combination regimen comprising (1) a GITR agonist agent, and (2) a PD-1 or PD-L1 antagonist agent, wherein the GITR agonist agent and the PD-1 or PD-L1 antagonist agent are administered on the same day and for at least one cycle, wherein each cycle comprises 4 administrations of the combination regimen,
- (b) measuring the level of (1) Ki67+CD8 cells;
- (2) Ki67+ and/or HLA-DR+memory T cells and/or (3) Ki67+NK cells in the circulating blood of the subject prior to, and within 3-10 days, after administration of a dose of the combination regimen;
- and
- (c) administering a second or subsequent dose of the combination regimen when the levels of (1) Ki67+CD8 cells;
- (2) Ki67+ and/or HLA-DR+memory T cells and/or (3) Ki67+NK cells, respectively, are at about their baseline level, wherein the baseline level is the level immediately prior to administration of a first or previous dose of the combination regimen.
3 more elements
A method of treating a human subject having an advanced solid cancer, comprising:
- (i) administering to the subject a combination regimen comprising (1) an anti-GITR agonist antibody which binds to human GITR, wherein the antibody comprises VH CDR1, CDR2, and CDR3 comprising the amino acid sequences set forth in SEQ ID NOs:
- 20, 21 and 22, respectively, and VL CDR1, CDR2, and CDR3 comprising the amino acid sequences set forth in SEQ ID NOs:
- 23, 24 and 25, and (2) an anti-PD-1 antagonist antibody,
- wherein the anti-GITR agonist antibody and the anti-PD-1 antagonist antibody are administered on the same day and for at least one 8-week cycle, wherein each cycle comprises 4 administrations of the combination regimen, wherein the anti-GITR agonist antibody is administered at a flat dose of 30-800 mg,
- wherein the combination regimen increases the level of one or more of the following cell populations in the peripheral blood of the subject by at least 1.5-fold higher relative to baseline:
- (a) Ki67+CD8 cells;
- (b) Ki67+ and/or HLA-DR+memory CD4+cells;
- (c) Ki67+ and/or HLA-DR+memory CD8 cells, and/or (d) Ki67+NK cells,
- (ii) measuring the level of (a) Ki67+CD8 cells;
- (b) Ki67+ and/or HLA-DR+memory T cells and/or (c) Ki67+NK cells in the circulating blood of the subject prior to, and within 3-10 days, after administration of a dose of the combination regimen;
- and
- (iii) administering a second or subsequent dose of the combination regimen when the levels of (a) Ki67+CD8 cells;
- (b) Ki67+ and/or HLA-DR+memory T cells and/or (c) Ki67+NK cells, respectively, are at about their baseline level, wherein the baseline level corresponds to the level before a first dose or previous dose of the combination regimen.
10 more elements
Dependencies are inferred from the claim text.