US 12,266,426 B2
Method for administering a cancer treatment
Shile Zhang, San Diego, CA (US); Mengchi Wang, La Jolla, CA (US); Aaron Wise, San Diego, CA (US); Han Kang, San Diego, CA (US); Vitor Ferreira Onuchic, San Diego, CA (US); and Kristina Kruglyak, San Diego, CA (US)
Assigned to Illumina, Inc., San Diego, CA (US)
Filed by ILLUMINA, INC., San Diego, CA (US)
Filed on Dec. 3, 2018, as Appl. No. 16/208,149.
Claims priority of provisional application 62/593,802, filed on Dec. 1, 2017.
Prior Publication US 2020/0176083 A1, Jun. 4, 2020
Prior Publication US 2023/0245724 A9, Aug. 3, 2023
Int. Cl. G16B 40/20 (2019.01); C12Q 1/6886 (2018.01); G06F 17/15 (2006.01); G06F 17/16 (2006.01); G06F 17/18 (2006.01); G16B 45/00 (2019.01); G16B 50/20 (2019.01); G16B 50/30 (2019.01); G16H 50/20 (2018.01); G16H 50/50 (2018.01)
CPC G16B 40/20 (2019.02) [C12Q 1/6886 (2013.01); G06F 17/153 (2013.01); G06F 17/16 (2013.01); G06F 17/18 (2013.01); G16B 45/00 (2019.02); G16B 50/20 (2019.02); G16B 50/30 (2019.02); G16H 50/20 (2018.01); G16H 50/50 (2018.01)] 16 Claims
 
1. A method for administering a cancer treatment, comprising:
a) obtaining a responsiveness score for a non-training subject having cancer, said obtaining comprising:
i) inputting total mutational burden, tumor infiltration, and factor expression of the non-training subject to a machine learning classifier;
wherein total mutational burden comprises one or both of all mutations and nonsynonymous mutations, tumor infiltration comprises any one or more of tumor infiltration by cells expressing cluster of differentiation 8 (CD8), tumor infiltration by cells expressing cluster of differentiation 4 (CD4), and tumor infiltration by cells expressing cluster of differentiation 19 (CD19), and factor expression comprises any one or more of beta 2 microglobulin (B2M) expression, proteasome subunit beta 10 (PSMB10) expression, antigen peptide transmitter 1 (TAP1) expression, antigen peptide transporter 2 (TAP2) expression, human leukocyte antigen A (HLA-A) expression, major histocompatibility complex class I B (HLA-B) expression, major histocompatibility complex class I C (HLA-C) expression, major histocompatibility complex class II DQ alpha 1 (HLA-DQA1) expression, HLA class II histocompatibility antigen DRB1 beta chain (HLA-DRB1) expression, HLA class I histocompatibility antigen alpha chain E (HLA-E) expression, natural killer cell granule protein 7 (NKG7) expression, chemokine like receptor 1 (CMKLR1) expression, granzyme A (GZMA) expression, perforin-1 (PRF1) expression, cytotoxic T-lymphocyte-associated protein 4 (CTLA4) expression, programmed cell death protein 1 (PD1) expression, programmed death-ligand 1 (PDL1) expression, programmed cell death 1 ligand 2 (PDL2) expression, lymphocyte-activation gene 3 (LAG3) expression, T cell immunoreceptor with Ig and ITIM domains (TIGIT) expression, cluster of differentiation 276 (CD276) expression, chemokine (C-C motif) ligand 5 (CCL5) expression, cluster of differentiation 27 (CD27) expression, chemokine (C-X-C motif) ligand 9 (CXCL9) expression, C-X-C motif chemokine receptor 6 (CXCR6) expression, indoleamine 2,3-dioxygenase (IDO) expression, signal transducer and activator of transcription 1 (STAT1) expression, 3-fucosyl-N-acetyl-lactosamine (CD15) expression, interleukin-2 receptor alpha chain (CD25) expression, siglec-3 (CD33) expression, cluster of differentiation 39 (CD39) expression, cluster of differentiation (CD118) expression, and forkhead box P3 (FOXP3) expression;
wherein the machine learning classifier is selected from the group consisting of a neural network classifier, a support vector machine, a max entropy classifier, an extreme gradient boosting classifier, a random fern classifier, and a random forest classifier,
and wherein the machine learning classifier was trained on said total mutational burden, tumor infiltration, and factor expression of a plurality of training subjects having cancer and a responsiveness of each of said plurality of training subjects to cancer treatment to predict responsiveness of said non-training subject to said cancer treatment; and
ii) generating, using the machine-learning classifier, a responsiveness score for the non-training subject; and
b) administering, based on said obtaining, the cancer treatment to the non-training subject for responsiveness scores that equal or exceed a predetermined threshold of 5;
wherein the cancer treatment is a checkpoint inhibitor selected from an anti-CTLA4 drug, an anti-PD1 drug, an anti-PDL1 drug, and any combination of two or more of said drugs.