How Can TKa Be Applied In Your Clinical Study?

In this scenario, different cohorts of patients are treated with a drug at different dosing levels. They are then tested for their TKa levels using the DiviTum TKa test to determine which dose provides the greatest effect on cell proliferation with the least amount of toxicity to the patient.

The DiviTum TKa test can be used to identify patients with high or low TKa expression. High cell proliferation has been demonstrated in clinical studies to be associated with aggressive cancer. Low cell proliferation — with slowly developing cancer. The test can be used as a selection criterion for the type of treatment applied. If you click on the hyperlinked study, you will see how the DiviTum TKa test was used to measure TKa levels at baseline. The study revealed both — that high baseline TKa levels were associated with a worse prognosis, and that patients with low TKa at baseline (the purplish-colored patients in the graphic) had comparable outcomes on single-agent or combination endocrine treatment. Hence, only single-agent endocrine treatment should be applied for patients with low TKa baseline levels to minimize treatment side-effects.

This scenario could be the continuation of the prior scenario. When patients are on a specific drug treatment, you can monitor their response to the drug using the DiviTum TKa test. This would enable you to keep responders (the purplish-colored patients in the graphic) on that drug. The responders are the ones with continued low and stable TKa values. The test would also enable you to treat non-responders – those with rising TKa values (colored orange in the graphic) with different dosing or dosing schedule — or switch, if possible, to another drug.

In this scenario, you measure the TKa level with the DiviTum TKa test at typically 3 different time points during early targeted drug treatment: for example, baseline, cycle 1-day 15, and cycle 1-day 28. The dynamics of the TKa biomarker measurements help you decide if the patient should continue with the current treatment protocol – in cases where patients are treated with antiproliferative therapies (eg. CDK4/6i and/or ET) and experience continued low and stable TKa value (the purplish-colored patients in the graphic). Patients exhibiting continued high TKa values during all testing timepoints or exhibit rising TKa value at second or third testing timepoints (the non-purplish-colored patients in the graphic) – would need to have their treatment protocol changed or optimized.