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AssigneeArcus Biosciences, Inc.
InventorsDaniel M. DIRENZO, Amy Grace DUPAGE, Kelsey Sivick GAUTHIER, Juan Carlos JAEN, Salema JAFRI, Omar KABBARAH, Angelo Jason Mirizzi KAPLAN, Dana PIOVESAN, Rebecca RAY, Lisa C. SEITZ, Matthew J. WALTERS, Jonathan Michael YINGLING
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Provided herein are biomarkers useful in the identification of a patient for a therapy comprising an immune checkpoint inhibitor, and methods of using the same. In particular, the present disclosure provides technologies for the treatment and prognostication of cancer in a patient utilizing biomarker expression levels in a biological sample obtained from the patient, as well as technologies for determining the likelihood that the patient will respond to a therapy comprising an immune checkpoint inhibitor.
Use of a biomarker to identify a patient for treatment with a combination therapy comprising an anti-TIGIT antibody and an anti-PD-(L)1 antibody, wherein the patient has cancer and is identified for treatment with the combination therapy when a sample obtained from the patient comprises a biomarker comprising a CD155 expression level greater than or equal to a CD155 reference level and wherein optionally the biomarker further comprises (a) a PD-L1 expression level greater than or equal to a PD-L1 reference level;
A method for treating cancer in a patient, comprising administering to the patient a combination therapy comprising a therapeutically effective amount of an anti-TIGIT antibody and a therapeutically effective amount of an anti-PD-(L)1 antibody when a sample obtained from the patient comprises a biomarker comprising a CD155 expression level greater than or equal to a CD155 reference level and wherein optionally the biomarker further comprises (a) a PD-L1 expression level greater than or equal to a PD-L1 reference level;
A method for identifying a patient with cancer for treatment with a combination therapy comprising a therapeutically effective amount of an anti-TIGIT antibody and a therapeutically effective amount of an anti-PD-(L)1 antibody, comprising:
A method for treating a patient, comprising:
The use or method of any one of the preceding claims, wherein the sample is a sample comprising tumor cells.
The use or method of any one of the preceding claims, wherein the sample is a sample comprising immune cells.
The use or method of any one of the preceding claims, wherein the sample is a tumor biopsy.
The use or method of any one of the preceding claims, wherein the CD155 expression level is measured by immunohistochemistry (IHC).
The use or method of any one of the preceding claims, wherein the reference level is (i) a median expression level derived from samples obtained from a group of patients with the same cancer, or (ii) an amount ≤30%, ≤25%, ≤20%, ≤15%, ≤10%, or ≤5% above or below the median expression level.
A method treating cancer in a patient having a CD155 high tumor, the method comprising administering to the patient a combination therapy comprising a therapeutically effective amount of a TIGIT antagonist and a therapeutically effective amount of a PD-(L)1 antagonist, wherein the CD155 high tumor has a CD155 expression level greater than or equal to (i) a median tumor H-score derived from samples obtained from a group of patients known to have the same cancer, or (ii) a value about 30%, about 25%, about 20%, about 15%, about 10%, or about 5% above or below the median tumor H-score.
A method treating cancer in a patient having a CD155 high tumor, the method comprising administering to the patient a combination therapy comprising a therapeutically effective amount of a TIGIT antagonist and a therapeutically effective amount of a PD-(L)1 antagonist, wherein a CD155 high tumor has a CD155 expression level greater than or equal to (i) a median 2+ or 3+ % TC derived from samples obtained from a group of patients known to have the same cancer, or (ii) a value about 30%, about 25%, about 20%, about 15%, about 10%, or about 5% above or below the median 2+ or 3+ % TC.
A method treating cancer in a patient having a CD155 high tumor, the method comprising administering to the patient a combination therapy comprising a therapeutically effective amount of a TIGIT antagonist and a therapeutically effective amount of a PD-(L)1 antagonist, wherein a CD155 high tumor has a CD155 tumor H-score ≥95, ≥100, ≥105, ≥110, ≥115, ≥120, ≥125, ≥130, ≥135, ≥140, ≥145, ≥150, ≥155, ≥160, ≥165, ≥170, or ≥175.
A method treating cancer in a patient having a CD155 high tumor, the method comprising administering to the patient a combination therapy comprising a therapeutically effective amount of a TIGIT antagonist and a therapeutically effective amount of a PD-(L)1 antagonist, wherein a CD155 high tumor has a CD155 2+ or 3+ % TC ≥30%, ≥35%, ≥40%, ≥45%, ≥50%, ≥55%, ≥60%, or ≥65%.
The method of 55, wherein the anti-TIGIT antibody is (i) an Fc-silent anti-TIGIT antibody, or (ii) domvanalimab.
A method treating cancer in a patient having a CD155 high tumor, the method comprising administering to the patient a combination therapy comprising a therapeutically effective amount of an anti-TIGIT antibody that is Fc-silent and a therapeutically effective amount of a PD-(L)1 antagonist, wherein a CD155 high tumor has a CD155 expression level greater than or equal to a CD155 reference level.
A method treating cancer in a patient having a CD155 high tumor, the method comprising administering to the patient a combination therapy comprising a therapeutically effective amount of an anti-TIGIT antagonist and a therapeutically effective amount of a PD-(L)1 antagonist, wherein a CD155 high tumor has a CD155 expression level greater than or equal to a CD155 reference level and wherein the PD-L1 expression level in the CD155 high tumor is ≥10% TC, ≥5% TAP, or ≥5% CPS.
The method of 72, wherein the anti-TIGIT antibody is (i) an Fe-silent anti-TIGIT antibody, or (ii) domvanalimab.
A method treating cancer in a patient having high expression levels of CXCL9, CXCL10, IL-6 or IFNγ before treatment, the method comprising administering to the patient a combination therapy comprising a therapeutically effective amount of a TIGIT antagonist and a therapeutically effective amount of a PD-(L)1 antagonist, wherein a high expression level of CXCL9, CXCL10, IL-6 or IFNγ is an amount greater than or equal to a reference value.
The method of 79, wherein the anti-TIGIT antibody is (i) an Fc-silent anti-TIGIT antibody, or (ii) domvanalimab.
Dependencies are inferred from the claim text.