Methods and kits for diagnosis of cancer and prediction of therapeutic value
AssigneeCornell University
InventorsNeil H. Bander, Joseph Osborne, Stanley J. Goldsmith, Shankar Vallabhajosula
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Abstract
A method for identifying a patient for cancer therapy can include administering a diagnostic dose of a detectably labeled first binding agent to a patient, the detectably labeled binding agent being capable of binding a molecular target. The method also includes selecting a patient for administration of a therapeutic dose of a second binding agent capable of binding a cellular target, wherein the selected patient exhibits a positive reading for the detectably labeled first binding agent. Furthermore, the method can include administering a therapeutic dose of the second binding agent to the patient.
Claims9
A method for identifying a patient who is predicted to be responsive to a PSMA-targeted cancer therapy comprising:
- (a) administering a detectably labeled PSMA-binding antibody or antigen-binding fragment thereof that binds to PSMA-expressing cells;
- (b) measuring quantitatively or semi-quantitatively by in vivo imaging the amount of the detectably labeled PSMA-binding antibody or antigen-binding fragment thereof that is bound to PSMA-expressing cells;
- (c) comparing the measured amount of the detectably labeled PSMA-binding antibody or antigen-binding fragment thereof that is bound to PSMA-expressing cells to a predetermined threshold, wherein the predetermined threshold is (1) a visual scoring scale of 2+ or 3+ wherein 2+ is an image or a sample having moderate uptake wherein the detectable tumor uptake is less than that in liver and 3+ is an image or a sample having a strong tumor uptake wherein the detectable tumor uptake is equal to or greater than the amount in liver, or (2) a tumor targeting index (TTI) value of 4 or higher, wherein the TTI index is determined as (lesion region of interest count density−background (lesion negative area) count density)/(total body count density);
- (d) selecting the patient for a PSMA-targeted cancer therapy if the measured amount meets or exceeds the predetermined threshold;
- wherein the patient has not previously been administered a PSMA-targeted cancer therapy;
- and
- wherein the detectably labeled PSMA-binding antibody or antigen-binding fragment thereof that binds to PSMA expressing cells is selected from the group consisting of J415, J591, E99, and J533, and
- (e) administering a PSMA-targeted cancer therapy to the selected patients, wherein the selected patients show a decrease in PSA level within 28 days post the administration of PSMA-targeted cancer therapy.
Dependencies are inferred from the claim text.