B7-H1 and methods of diagnosis, prognosis, and treatment of cancer
AssigneeMayo Foundation for Medical Education and Research
InventorsLieping Chen, Scott E. Strome, Eugene D. Kwon
Life of this patent
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Abstract
The invention features methods of diagnosis by assessing B7-H1 expression in a tissue from a subject that has, or is suspected of having, cancer, methods of treatment with agents that interfere with B7-H1-receptor interaction, methods of selecting candidate subjects likely to benefit from cancer immunotherapy, and methods of inhibiting expression of B7-H1.
Claims22
A method for the treatment of a subject with cancer, wherein some or all cells of the cancer or some or all tumor-infiltrating leukocytes in cancer tissue express B7-H1, comprising
- administering to the subject an agent which is an antibody or an antigen-binding antibody fragment that interferes with an interaction between B7-H1 and a receptor for B7-H1, wherein said subject is a human or mouse and said B7-H1 is human B7-H1 (hB7-H1) or mouse B7-H1 (mB7-H1), respectively,
- wherein said subject has been identified for said administration by a test on a sample of cancerous tissue from said subject, wherein said tissue sample contains test cells, said test cells being cancer cells or tumor-infiltrating leukocytes,
- and said test was an assessment of the level of test cells in the tissue sample that express B7-H1,
- said identification being made if, the level of test cells in the tissue sample that express said B7-H1 is less than an immuno-inhibitory threshold level, wherein said immuno-inhibitory threshold level is determined by performing a statistical analysis of the correlation between the proportion of cells expressing B7-H1 in a group of subjects with said cancer and an expected risk of death in said group of subjects, and assigning a statistically significant cut-off value for said correlation.
A method of identifying a subject having renal cell carcinoma (RCC) suitable for B7-H1 based immunotherapy, comprising
- (i) providing a cancer tissue sample from a subject with RCC, wherein the tissue sample contains test cells, the test cells being cancer cells or tumor-infiltrating leukocytes;
- and
- (ii) assessing the level of test cells in the tissue sample that express B7-H1,
- wherein said subject is a human or mouse and said B7-H1 is human B7-H1 (hB7-H1) or mouse B7-H1 (mB7-H1), respectively;
- wherein, if the level of test cells expressing said B7-H1 is less than an immuno-inhibitory threshold level, the subject is determined to benefit from immunotherapy with an agent which is an antibody or an antigen-binding antibody fragment that interferes with an interaction between B7-H1 and a receptor for B7-H1, wherein said immuno-inhibitory threshold level is determined by performing a statistical analysis of the correlation between the proportion of cells expressing B7-H1 in a group of subjects with RCC and an expected risk of death in said group of subjects, and assigning a statistically significant cut-off value for said correlation.
Dependencies are inferred from the claim text.