	US 12,240,903 B2
	Biomarkers for determining the effectiveness of immune checkpoint inhibitors
Hiroyoshi Nishikawa, Chiba (JP); Yosuke Togashi, Chiba (JP); Yukiya Ohyama, Osaka (JP); Takao Yoshida, Osaka (JP); Kazuhiko Takeda, Osaka (JP); Kenichi Koda, Osaka (JP); Atsushi Honda, Osaka (JP); Atsushi Oyagi, Osaka (JP); Toru Kakinuma, Osaka (JP); and Masayuki Murata, Osaka (JP)
Assigned to ONO PHARMACEUTICAL CO., LTD., Osaka (JP); and NATIONAL CANCER CENTER, Tokyo (JP)
Appl. No. 17/058,794
Filed by ONO PHARMACEUTICAL CO., LTD., Osaka (JP); and NATIONAL CANCER CENTER, Tokyo (JP)
PCT Filed May 30, 2019, PCT No. PCT/JP2019/021633 § 371(c)(1), (2) Date Nov. 25, 2020, PCT Pub. No. WO2019/230919, PCT Pub. Date Dec. 5, 2019.
Claims priority of application No. 2018-105017 (JP), filed on May 31, 2018; and application No. 2018-189370 (JP), filed on Oct. 4, 2018.
Prior Publication US 2021/0198361 A1, Jul. 1, 2021
Int. Cl. C07K 16/28 (2006.01); A61K 39/00 (2006.01); A61P 35/00 (2006.01); G01N 33/50 (2006.01)

CPC C07K 16/2818 (2013.01) [A61P 35/00 (2018.01); G01N 33/505 (2013.01); A61K 2039/507 (2013.01); G01N 2800/52 (2013.01)]

19 Claims

1. A method for suppressing progression of, suppressing recurrence of, and/or treating malignant tumor, comprising:

obtaining a tumor tissue sample from a patient with malignant tumor;

detecting amounts of a PD-1 expression intensity in CD8⁺ T cells and a PD-1 expression intensity in Treg cells in the tumor tissue sample;

identifying that the patient has a ratio of the PD-1 expression intensity in CD8⁺ T cells to the PD-1 expression intensity in Treg cells in the tumor tissue of 0.7 or more; and

administering an effective amount of an agent containing a substance inhibiting an immune checkpoint as an active ingredient, to the patient in need thereof, identified as having the ratio of 0.7 or more.