Aspects of the present disclosure provide methods for determining the eligibility of a subject having a malignancy for treatment with an anti-PD therapeutic agent based on a Combined Positive Score (CPS) for a tumor tissue sample from the subject. Compositions and kits or performing the disclosed methods are also provided.

A method for detecting a tumor cell surface marker molecule PD-L1, comprising the following steps: providing a capture screen that has antibodies capable of specifically binding to tumor cells; making a sample to be tested flow through the capture screen, such that tumor cells in the sample to be tested bind to the capture screen; fixing captured tumor cells on the capture screen; and successively using a PD-L1 primary antibody solution, a PD-L1 secondary antibody solution labeled with a fluorophore AlexaFluor 647, a pan-CK-AlexaFluor 488 primary antibody solution, a CD45 primary antibody solution and a CD45 secondary antibody solution labeled with a fluorophore AlexaFluor 568, to incubate the cells fixed on the capture screen, and then labeling all cells on the capture screen with a nuclear fluorescent dye.

The present disclosure relates generally to methods and compositions for cancer immunotherapy, and more specifically, liquid markers for predicting effectiveness of cancer therapies. The disclosure features compositions and methods that are useful for predicting the efficacy of cancer treatment (e.g., a checkpoint inhibitor immunotherapy) and, in some embodiments, administering the cancer treatment such as immunotherapy.

Provided are an anti-B7-H3 antibody binding specifically to B7-H3 and a use thereof and, more particularly, are an anti-B7-H3 antibody or an antigen binding fragment thereof, a nucleic acid encoding the same, a vector carrying the nucleic acid, a cell transformed with the vector, a method for preparing the same, an antibody-drug conjugate or a multi-specific antibody comprising the same, and a pharmaceutical composition for preventing or treating cancer, autoimmune disease, or inflammatory disease, or a diagnostic composition, each composition comprising the same. The anti-B7-H3 antibody or antigen binding fragment thereof can bind to human and non-human B7-H3 at high affinity and can be endocytosized after binding thereto. Thus, the anti-B7-H3 antibody or antigen binding fragment thereof, or the antibody-drug conjugate or the multi-specific antibody comprising the same can be advantageously used for preventing, treating, or diagnosing cancer or tumor, autoimmune disease, or inflammatory disease.

The present invention provides methods to improve a cancer patient's response to immune checkpoint inhibitor (ICI) therapy, and functional test to predict likelihood of response. Specifically, the invention provides methods to improve patient's response to immune checkpoint inhibitors using modulators and to predict response to the combination of immune checkpoint inhibitors and modulators.

Methods for treating and/or prognosing breast cancer and breast cancer recurrence are provided. The method includes obtaining a tissue sample of a tumor from a breast cancer patient, determining an expression level of one or more markers (for example PD-1 and/or PD-L1) in the sample, and providing intensified treatment to the subject based on the level of (for example) PD-1 and/or PD-L1. The intensified treatment can be intensified radiotherapy treatment.

The disclosure provides methods of treating, identifying and/or selecting for treatment a subject having a cancer in which an immune checkpoint protein is upregulated. In certain embodiments, the methods for treating cancer in a subject in need thereof comprise administering to the subject: (a) a therapeutically effective amount of an EZH2 inhibitor and (b) a therapeutically effective amount of an immune checkpoint inhibitor. In certain embodiments of the methods of the disclosure, the EZH2 inhibitor is tazemetostat.

The present invention provides markers for judging the efficacy of therapy with a PD-1 signal inhibitor before or at an early stage of the therapy. As biomarkers for predicting or judging the efficacy of therapy with a PD-1 signal inhibitor, surrogate indicators of metabolic changes relating to mitochondrial activity in T cells and/or T cell activation in a subject are used. As such indicators, intestinal flora-related metabolites in the serum or plasma, energy metabolism-related metabolites in the serum or plasma, amino acid metabolism-related metabolites and/or derivatives thereof in the serum of plasma, oxygen consumption rate and/or ATP turnover in peripheral blood CD8.sup.+ cells, amino acids in T cells, and T-bet in peripheral blood CD8.sup.+ cells may be used.

Systems and methods are presented that allow for predicting treatment response of a tumor to a checkpoint inhibitor. In one exemplary aspect, the treatment response is directly associated with a relatively high number of patient- and tumor-specific immunologically visible neoepitopes. Specific mutational patterns in the nucleic acid encoding the neoepitope may be further indicative of treatment response.

The present invention relates, in part, to methods for selecting subjects for and treating subjects with a type of immunotherapy based on certain biomarkers from the subjects.