Biomarkers and methods of treating PD-1 and PD-L1 related conditions
AssigneeGenentech, Inc.
InventorsDaniel Shin-Yu Chen, Priti Hegde, Hartmut Koeppen, Marcin Kowanetz
Life of this patent
Estimating the term…
Abstract
Provided herein are biomarkers for the treatment of pathological conditions, such as cancer, and method of using PD-1/PD-L1 pathway antagonists. In particular, provided are biomarkers for patient selection and prognosis in cancer, as well as methods of therapeutic treatment, articles of manufacture and methods for making them, diagnostic kits, methods of detection and methods of advertising related thereto.
Claims26
A method for treating a metastatic non-small cell lung cancer in an individual who is likely to have an increased clinical benefit from treatment with an anti-PD-L1 antibody, the method comprising:
- (a) detecting the presence of a PD-L1 protein in tumor infiltrating immune cells in a tumor tissue sample obtained from the individual;
- and
- (b) determining the level of PD-L1 protein in tumor infiltrating immune cells in the tumor tissue sample, wherein the tumor infiltrating immune cells include T lymphocytes, and wherein the tumor tissue sample from the individual has a detectable expression level of the PD-L1 protein in tumor infiltrating immune cells covering ≥ 10% of tumor area in the tumor tissue sample, thereby indicating that the individual is likely to have an increased clinical benefit from treatment with the anti-PD-L1 antibody;
- and
- (c) administering an effective amount of an anti-PD-L1 antibody to the individual,
- wherein the tumor tissue sample from the individual is obtained prior to treatment with the anti-PD-L1 antibody, and wherein the anti-PD-L1 antibody is atezolizumab (MPDL3280A).
A method for treating a metastatic non-small cell lung cancer in an individual who is likely to have an increased clinical benefit from treatment with an anti-PD-L1 antibody, the method comprising:
- (a) detecting presence of a PD-L1 protein in tumor infiltrating immune cells in a tumor tissue sample obtained from the individual;
- and
- (b) determining the level of PD-L1 protein in tumor infiltrating immune cells in the tumor tissue sample, wherein the tumor infiltrating immune cells include T lymphocytes, and wherein the tumor tissue sample from the individual has a detectable expression level of the PD-L1 protein in tumor infiltrating immune cells covering ≥ 10% of tumor area in the tumor tissue sample, thereby indicating that the individual is likely to have an increased clinical benefit from treatment with the anti-PD-L1 antibody;
- and
- (c) administering an effective amount of an anti-PD-L1 antibody to the individual,
- wherein the tumor tissue sample from the individual is obtained prior to treatment with the anti-PD-L1 antibody, wherein the anti-PD-L1 antibody is atezolizumab (MPDL3280A), wherein the increased clinical benefit comprises a relative increase in ORR, and wherein the PD-L1 protein is detected using IHC.
Dependencies are inferred from the claim text.