	US 12,263,147 B2
	Treatment of STK11-loss cancers
Douglas W. Cress, Wesley Chapel, FL (US); John Cleveland, Land O'Lakes, FL (US); and Nicholas Gimbrone, Atlanta, GA (US)
Assigned to H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL (US)
Appl. No. 17/298,251
Filed by H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL (US)
PCT Filed Dec. 26, 2019, PCT No. PCT/US2019/068571 § 371(c)(1), (2) Date May 28, 2021, PCT Pub. No. WO2020/139941, PCT Pub. Date Jul. 2, 2020.
Claims priority of provisional application 62/830,795, filed on Apr. 8, 2019.
Claims priority of provisional application 62/785,468, filed on Dec. 27, 2018.
Prior Publication US 2022/0110898 A1, Apr. 14, 2022
Int. Cl. A61K 31/198 (2006.01); A61K 45/06 (2006.01); A61P 35/00 (2006.01)

CPC A61K 31/198 (2013.01) [A61K 45/06 (2013.01); A61P 35/00 (2018.01)]

7 Claims

1. A method for treating a subject with lung cancer, consisting of

(a) assaying a biopsy sample comprising lung cancer cells from the subject for STK11 (Liver kinase 1, LKB1) somatic mutations, protein biomarkers of STK11 signaling, mRNA biomarkers of STK11 signaling, or any combination thereof;

(b) detecting from the assay a loss of STK11 function in the lung cancer cells;

(c) administering to the subject a therapeutically effective amount of an ornithine decarboxylase (ODC) inhibitor to treat the lung cancer;

(d) administering to the subject an immunotherapy agent; and

(e) optionally administering to the subject celecoxib, cyclophosphamide, topotecan, or any combination thereof.