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US 11,635,435 B2Granted
Diagnostic, prognostic, and monitoring methods for solid tumor cancers
AssigneeOncoTracker, Inc.
InventorJames Richard Berenson
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Abstract
The compositions and methods of the invention relate generally to detection of biomarkers for the diagnosis, prognosis, and monitoring of solid tumor cancers. In particular, the invention relates to compositions and methods for detection of B-cell maturation antigen (BCMA) for the diagnosis, prognosis, and monitoring of solid tumor type of cancers.
Claims19
A method of treatment for a solid tumor type of cancer in a subject, comprising:
- (a) detecting an amount of BCMA polypeptide or a cleaved BCMA polypeptide having at least 75% or at least 80% or at least 90% sequence identity to SEQ ID NO:
- 1 in a first biological sample obtained from the subject, wherein:
- (i) the amount of BCMA polypeptide or cleaved BCMA polypeptide in the first biological sample being lower than about 40 ng/mL correlates with a reduced time to progression (TTP) of the cancer;
- or (ii) the amount of BCMA polypeptide or cleaved BCMA polypeptide in the first biological sample being lower than about 40 ng/mL indicates a reduced length of progression-free survival (PFS) for the subject;
- or (iii) the amount of BCMA polypeptide or cleaved BCMA polypeptide in the first biological sample being lower than about 20 ng/mL or higher than about 100 ng/mL indicates a reduced overall survival (OS) for the subject;
- (b) treating the subject for the solid tumor type of cancer;
- (c) detecting an amount of BCMA polypeptide or a cleaved BCMA polypeptide having at least 75% or at least 80% or at least 90% sequence identity to SEQ ID NO:
- 1 in a second biological sample obtained from the subject at a time point following treatment wherein:
- (i) the amount of BCMA polypeptide or cleaved BCMA polypeptide in the second biological sample being lower than about 40 ng/mL correlates with a reduced time to progression (TTP) of the cancer;
- or (ii) the amount of BCMA polypeptide or cleaved BCMA polypeptide in the second biological sample being lower than about 40 ng/mL indicates a reduced length of progression-free survival (PFS) for the subject;
- or (iii) the amount of BCMA polypeptide or cleaved BCMA polypeptide in the second biological sample being lower than about 20 ng/mL or higher than about 100 ng/mL indicates a reduced overall survival (OS) for the subject;
- and
- (d) comparing the amount of BCMA polypeptide or a cleaved BCMA polypeptide having at least 75% or at least 80% or at least 90% sequence identity to SEQ ID NO:
- 1 in the first and second samples to monitor changes in TTP, PFS or OS;
- (e) Changing the treatment for the solid tumor type of cancer when the amount of BCMA polypeptide or cleaved BCMA polypeptide in the second biological sample is lower than about 40 ng/ml or higher than about 100 ng/ml;
- or maintaining or discontinuing treatment for the solid tumor type of cancer when the amount of BCMA polypeptide or cleaved BCMA polypeptide in the second biological sample is higher than about 40 ng/ml and lower than about 100 ng/ml.
13 more elements
A method of treatment involving monitoring progression or response to treatment of solid tumor cancer in a subject diagnosed with the cancer, comprising,
- (a) treating the subject for the solid tumor cancer;
- (b) detecting an amount of BCMA or a cleaved BCMA polypeptide having at least 75% or at least 80% or at least 90% sequence identity to SEQ ID NO:
- 1 in a biological sample obtained from the subject at a time point following treatment, wherein:
- (i) an amount of BCMA polypeptide or cleaved BCMA polypeptide in the biological sample of lower than about 40 ng/mL or higher than about 100 ng/mL indicates that the cancer will progress sooner;
- or (ii) an amount of BCMA polypeptide or a fragment thereof in the biological sample of higher than about 40 ng/mL but lower than 100 ng/mL indicates that the cancer is more likely to enter remission or respond to treatment.
2 more elements
A method of treating breast cancer in a subject, comprising:
- a) detecting an amount of BCMA polypeptide or cleaved BCMA polypeptide having at least 75% or at least 80% or at least 90% sequence identity to SEQ ID NO:
- 1 in a biological sample obtained from the subject;
- and
- b) if the amount is greater than 15 ng/mL, administering an effective amount of letrozole, megestrol acetate, or letrozole and megestrol acetate.
1 more element
Dependencies are inferred from the claim text.