Biomarker indicating response to poziotinib therapy for cancer

Use of poziotinib in the preparation of medicaments for the treatment of a subject having cancer, wherein the subject has cancer cells that have

• at least one selected from copy number amplification of the ERBB2 gene, one or more mutations in an ERBB2 gene region including the ERBB2 gene and a sequence within 10 kb upstream of the ERBB2 gene, the ERBB3 wild-type gene, the BARD1 wild-type gene, the SETBP1 wild-type gene, the PIK3CA wild-type gene, one or more mutations in the NOTCH3 gene, one or more mutations in the SH2B3 gene, copy number amplification of the CDK12 gene, copy number deletion of the BRCA1 gene, copy number deletion of the STAT3 gene, and no copy number variation of the FGFR3 gene.

A method of treating cancer in a subject, the method comprising administering a therapeutically effective amount of poziotinib to the subject having cancer, wherein the subject has cancer cells that have

• at least one selected from copy number amplification of the ERBB2 gene, one or more mutations in an ERBB2 gene region including the ERBB2 gene and a sequence within 10 kb upstream of the ERBB2 gene, the ERBB3 wild-type gene, the BARD1 wild-type gene, the SETBP1 wild-type gene, the PIK3CA wild-type gene, one or more mutations in the NOTCH3 gene, one or more mutations in the SH2B3 gene, copy number amplification of the CDK12 gene, copy number deletion of the BRCA1 gene, copy number deletion of the STAT3 gene, and no copy number variation of the FGFR3 gene.

A method of identifying a subject having poziotinib-sensitive cancer, the method comprising:

• detecting that a cancer cell-containing sample obtained from a subject has at least one selected from copy number amplification of the ERBB2 gene, one or more mutations in an ERBB2 gene region including the ERBB2 gene and a sequence within 10 kb upstream of the ERBB2 gene, the ERBB3 wild-type gene, the BARD1 wild-type gene, the SETBP1 wild-type gene, the PIK3CA wild-type gene, one or more mutations in the NOTCH3 gene, one or more mutations in the SH2B3 gene, copy number amplification of the CDK12 gene, copy number deletion of the BRCA1 gene, copy number deletion of the STAT3 gene, and no copy number variation of the FGFR3 gene,
• wherein having at least one selected from copy number amplification of the ERBB2 gene, one or more mutations in an ERBB2 gene region including the ERBB2 gene and a sequence within 10 kb upstream of the ERBB2 gene, the ERBB3 wild-type gene, the BARD1 wild-type gene, the SETBP1 wild-type gene, the PIK3CA wild-type gene, one or more mutations in the NOTCH3 gene, one or more mutations in the SH2B3 gene, copy number amplification of the CDK12 gene, copy number deletion of the BRCA1 gene, copy number deletion of the STAT3 gene, and no copy number variation of the FGFR3 gene indicates that the cancer cells are sensitive to poziotinib.

A method of treating cancer in a subject, the method comprising administering a therapeutically effective amount of therapeutic drugs other than poziotinib to the subject having cancer, wherein the subject has cancer cells that have at least one selected from

• the existence of one or more mutations in the ERBB3 gene, the existence of one or more mutations in the BARD1 gene, the absence of one or more mutations in the NOTCH3 gene, the absence of one or more mutations in the SH2B3 gene, the existence of one or more mutations in the SETBP1 gene, the existence of one or more mutations in the PIK3CA gene, the absence of amplification of the CDK12 gene, the absence of copy number variation of the ERBB2 gene, the absence of copy number variation of the BRCA1 gene, the absence of copy number variation of the STAT3 gene, and the existence of copy number variation of the FGFR3 gene.

A method of treating cancer in a subject, the method comprising:

• selecting a subject for cancer treatment with breast cancer therapeutic drugs other than poziotinib based on whether cancer cells isolated from the subject have at least one selected from the existence of one or more mutations in the ERBB3 gene, the existence of one or more mutations in the BARD1 gene, the absence of one or more mutations in the NOTCH3 gene, the absence of one or more mutations in the SH2B3 gene, the existence of one or more mutations in the SETBP1 gene, the existence of one or more mutations in the PIK3CA gene, the absence of amplification of the CDK12 gene, the absence of copy number variation of the ERBB2 gene, the absence of copy number variation of the BRCA1 gene, the absence of copy number variation of the STAT3 gene, and the existence of copy number variation of the FGFR3 gene, wherein the having of the at least one indicates that the cancer cells are resistant to poziotinib;
• and
• administering a therapeutically effective amount of the breast cancer therapeutic drugs other than poziotinib to a selected subject.

A method of treating poziotinib-resistant cancer in a subject, the method comprising:

• detecting that cancer cells obtained from a subject have at least one selected from the existence of one or more mutations in the ERBB3 gene, the existence of one or more mutations in the BARD1 gene, the absence of one or more mutations in the NOTCH3 gene, the absence of one or more mutations in the SH2B3 gene, the existence of one or more mutations in the SETBP1 gene, the existence of one or more mutations in the PIK3CA gene, the absence of amplification of the CDK12 gene, the absence of copy number variation of the ERBB2 gene, the absence of copy number variation of the BRCA1 gene, the absence of copy number variation of the STAT3 gene, and the existence of copy number variation of the FGFR3 gene, wherein the having of the at least one indicates that the cancer cells are resistant to poziotinib;
• and
• administering a therapeutically effective amount of the breast cancer therapeutic drugs other than poziotinib to a subject.

A method of identifying a subject having poziotinib-resistant cancer, the method comprising:

• detecting that a cancer cell-containing sample obtained from a subject has at least one selected from the existence of one or more mutations in the ERBB3 gene, the existence of one or more mutations in the BARD1 gene, the absence of one or more mutations in the NOTCH3 gene, the absence of one or more mutations in the SH2B3 gene, the existence of one or more mutations in the SETBP1 gene, the existence of one or more mutations in the PIK3CA gene, the absence of amplification of the CDK12 gene, the absence of copy number variation of the ERBB2 gene, the absence of copy number variation of the BRCA1 gene, the absence of copy number variation of the STAT3 gene, and the existence of copy number variation of the FGFR3 gene, wherein having of the at least one indicates that the cancer cells are resistant to poziotinib.