	US 11,899,017 B2
	Predictive peripheral blood biomarker for checkpoint inhibitors
Nataly Manjarrez Orduño, Princeton, NJ (US); and Suzanne J. Suchard, Portland, OR (US)
Assigned to Bristol-Myers Squibb Company, Princeton, NJ (US)
Appl. No. 16/634,833
Filed by Bristol-Myers Squibb Company, Princeton, NJ (US)
PCT Filed Jul. 27, 2018, PCT No. PCT/US2018/044168 § 371(c)(1), (2) Date Jan. 28, 2020, PCT Pub. No. WO2019/023624, PCT Pub. Date Jan. 31, 2019.
Claims priority of provisional application 62/691,556, filed on Jun. 28, 2018.
Claims priority of provisional application 62/582,166, filed on Nov. 6, 2017.
Claims priority of provisional application 62/538,509, filed on Jul. 28, 2017.
Prior Publication US 2021/0123920 A1, Apr. 29, 2021
Int. Cl. A61K 39/395 (2006.01); C07K 16/28 (2006.01); A61P 35/00 (2006.01); G01N 33/574 (2006.01); G01N 33/569 (2006.01); A61K 45/06 (2006.01); A61K 39/00 (2006.01)

CPC G01N 33/57484 (2013.01) [A61K 45/06 (2013.01); C07K 16/2818 (2013.01); C07K 16/2827 (2013.01); A61K 2039/507 (2013.01); G01N 2800/52 (2013.01)]

6 Claims

1. A method of treating a subject having cancer, comprising administering an antibody that specifically binds PD-1 (anti-PD-1 antibody) or PD-L1 (anti-PD-L1 antibody) to a subject identified as having (a) a circulating central memory T Cells (TCM): circulating T effector memory cells (Teff) ratio that is similar to or higher than the TCM: Teff ratio in the top 90% of healthy subjects; or

both (i) a circulating CD4+ TCM: circulating CD4+ Teff ratio and (ii) a circulating CD8+ TCM: circulating CD8+ Teff ratio that are similar to or higher than those, respectively, in the top 90% of healthy subjects;

wherein the anti-PD-1 antibody or anti-PD-L1 antibody is only administered to the subject if more than or equal to 1% of tumor cells in the subject express PD-L1 and wherein the Teff cells are negative for CD45RA and CCR7.