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US 2019/0292605 A1Published application
Biomarkers of Response to Cyclin D-CDK4/6 Targeted Therapies in Cancer
AssigneeThe Regents of the University of California
InventorsDennis Slamon, Richard Finn, Dylan Conklin, Erika von Euw
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Abstract
Provided herein are biomarkers indicating sensitivity or resistance to Cyclin D-CDK4/6 inhibitor therapy in cancer and methods of use.
Claims22
1-37. (canceled)
A method of testing a subject having cancer, the method comprising:
- (a) obtaining a tumor sample from the subject;
- (b) assaying for the presence of at least one biomarker selected from the group consisting of:
- (i)) a chromosomal deletion of RB1,
- (ii) a chromosomal amplification of 19q12 (CCNE1),
- (iii) loss of p16,
- (iv) an activating point mutation of the smoothened (SMO) gene,
- (v) an activating point mutation of the RET proto-oncogene,
- (vi) a loss-of-function point mutation of FBXW7,
- (vii) a loss-of-function point mutation of retinoblastoma (RB1),
- (viii) a chromosomal amplification of sonic hedgehog (SHH),
- (ix) high baseline GLI2 mRNA expression,
- (x) high baseline SMO mRNA expression, and
- (xi) p21 gain,
- wherein the presence of the at least one biomarker indicates that the subject is unlikely to respond to a treatment with at least one CDK4 inhibitor-, one CDK6 inhibitor-, or one cyclin D inhibitor, or combinations thereof.
11 more elements
A method of testing a subject having cancer, the method comprising:
- (a) obtaining a tumor sample from the subject;
- (b) assaying for the presence of at least one biomarker selected from the group consisting of:
- (i) copy number amplification of RB1,
- (ii) chromosomal amplification of 17q12-21 (ERBB2),
- (iii) chromosomal amplification of 11q13 (CCND1),
- (iv) chromosomal amplification of 1q (MDM4),
- (v) high p16 protein,
- (vi) a loss-of-function point mutation in CDH1,
- (vii) cyclin D1 amplification,
- (viii) HER2 amplification,
- (ix) loss-of-function point mutations in TOPBP1,
- (x) decrease in phospho-Rb, and
- (xi) decrease in FOXM1 protein,
- wherein the presence of the at least one biomarker indicates that the subject is likely to respond to a treatment with at least one CDK4 inhibitor-, CDK6 inhibitor-, cyclin D inhibitor, or combinations thereof.
11 more elements
Dependencies are inferred from the claim text.