Method of deriving a value for percent biomarker positivity for selected cells present in a field of view

Abstract

The invention relates, in part, to methods of deriving a value for % biomarker positivity (PBP) for all cells or optionally, one or more subsets thereof, present in a field of view of a tissue sample from a cancer patient. The values for PBP can be indicative of a patient's response to immunotherapy.

What is claimed is: 
     
         1 . A method of monitoring a progress of a patient diagnosed with cancer and undergoing immunotherapy, comprising:
 (i) using at least two samples comprising tumor tissue taken from a cancer patient over at least two time points, one prior to and one after initiation of immunotherapy, deriving a value for % biomarker positivity (PBP) for all non-tumor cells expressing a biomarker of interest for each of said at least two samples to obtain at least a first value for PBP and at least a second value for PBP; and   (ii) recording said at least first value for PBP and said at least second value for PBP, a change between said at least first value for PBP and said at least second value for PBP being indicative of an effectiveness of said immunotherapy.   
     
     
         2 . The method of  claim 1  in which the biomarker of interest comprises a biomarker selected from the group consisting of CD11b, CD33, HLA-DR, IDO-1, ARG1, granzyme B, B2M, PD-L1, PD-L2, B7-H3, B7-H4, 4.1BBL, ICOSL, CD40, OX40L, GITRL, PD-1, TIM3, LAG3, 41BB, OX40, CTLA-4, CD40L, GITR, ICOS, CD28, CD3, CD4, CD8, FoxP3, CD25, CD16, CD56, CD68, CD163, CD80, and CD86. 
     
     
         3 . The method of  claim 1  in which the biomarker of interest comprises PD-L1. 
     
     
         4 . The method of  claim 1  in which the biomarker of interest comprises PD-L2. 
     
     
         5 . The method of  claim 1  in which the biomarker of interest comprises PD-1. 
     
     
         6 . The method of  claim 1  in which the biomarker of interest comprises HLA-DR. 
     
     
         7 . The method of  claim 1  in which the biomarker of interest comprises CD8. 
     
     
         8 . The method of  claim 1  in which the non-tumor cells comprise immune cells and stromal cells. 
     
     
         9 . The method of  claim 1  in which the non-tumor cells comprise myeloid cells. 
     
     
         10 . The method of  claim 1  in which the immunotherapy comprises immune checkpoint therapy. 
     
     
         11 . A method of monitoring a progress of a patient diagnosed with cancer and undergoing immunotherapy, comprising:
 (i) using at least two samples comprising tumor tissue taken from a cancer patient over at least two time points, one prior to and one after initiation of immunotherapy, deriving a value for % biomarker positivity (PBP) for all tumor cells expressing a biomarker of interest for each of said at least two samples to obtain at least a first value for PBP and at least a second value for PBP; and   (ii) recording said at least first value for PBP and said at least second value for PBP, a change between said at least first value for PBP and said at least second value for PBP being indicative of an effectiveness of said immunotherapy.   
     
     
         12 . The method of  claim 11  in which the biomarker of interest comprises a biomarker selected from the group consisting of PD-L1, Galectin 9, and MHC. 
     
     
         13 . The method of  claim 11  in which the biomarker of interest comprises PD-L1. 
     
     
         14 . The method of  claim 11  in which the biomarker of interest comprises Galectin 9. 
     
     
         15 . The method of  claim 11  in which the biomarker of interest comprises MHC. 
     
     
         16 . The method of  claim 11  in which the field of view comprises non-tumor cells. 
     
     
         17 . The method of  claim 16  in which the non-tumor cells comprise immune cells and stromal cells. 
     
     
         18 . The method of  claim 11  in which the immunotherapy comprises immune checkpoint therapy.