US 11,852,631 B2
Biomarkers predictive of anti-immune checkpoint response
Rizwan Haq, Boston, MA (US); and Cecile Marie Gstalder, Boston, MA (US)
Assigned to Dana-Farber Cancer Institute, Inc., Boston, MA (US)
Appl. No. 16/771,802
Filed by Dana-Farber Cancer Institute, Inc., Boston, MA (US)
PCT Filed Jan. 18, 2019, PCT No. PCT/US2019/014117
§ 371(c)(1), (2) Date Jun. 11, 2020,
PCT Pub. No. WO2019/143880, PCT Pub. Date Jul. 25, 2019.
Claims priority of provisional application 62/619,524, filed on Jan. 19, 2018.
Prior Publication US 2021/0072248 A1, Mar. 11, 2021
Int. Cl. G01N 33/574 (2006.01); A61P 35/04 (2006.01); A61K 39/395 (2006.01); A61K 45/06 (2006.01); C07K 16/28 (2006.01); C12N 9/22 (2006.01); C12N 15/113 (2010.01); G01N 33/50 (2006.01); A61K 39/00 (2006.01)
CPC G01N 33/57492 (2013.01) [A61K 39/3955 (2013.01); A61K 45/06 (2013.01); A61P 35/04 (2018.01); C07K 16/2818 (2013.01); C12N 9/22 (2013.01); C12N 15/113 (2013.01); G01N 33/5017 (2013.01); A61K 2039/505 (2013.01); A61K 2039/507 (2013.01); A61K 2039/545 (2013.01); C07K 2317/24 (2013.01); C07K 2317/76 (2013.01); C12N 2310/20 (2017.05); C12N 2800/80 (2013.01)] 6 Claims
 
1. A method of identifying the likelihood of treating a colorectal or melanoma cancer in a subject likely to be resistant to an immune checkpoint therapy, wherein the immune checkpoint therapy comprises anti-PD-1 antibodies, anti-PD-L1 antibodies, and/or anti-PD-L2 antibodies, the method comprising:
i) selecting the subject, the subject having been identified according to:
a) obtaining or providing a sample comprising cancer cells from a subject having the cancer;
b) measuring the presence, copy number, or amount of Fbxw7 in the subject sample; and
c) comparing the presence, copy number, or amount of Fbxw7 in a control,
wherein the presence of or a significantly increased amount of wild-type Fbxw7 in the subject sample and/or the absence of or a decreased amount of Fbxw7 having a loss of function mutation in the subject sample relative to the control identifies the cancer as being likely to be responsive to the immune checkpoint therapy; and
ii) administering the immune checkpoint therapy to the selected subject.