“We are very proud to be partnering with Yale on such an important prospective study. If successful, the trial strengthens DiviTum TKa’s clinical evidence, which is very valuable in relation to guidelines and reimbursement. Ultimately, the correlation between DiviTum TKa, improved CDK4/6i response, and better outcomes is what Biovica is striving for on behalf of patients,” said Anders Rylander, CEO of Biovica.
The study aims to correlate thymidine kinase activity (TKa) levels, as measured by DiviTum TKa, with medication non-compliance, potential drug-drug interaction issues, and the effects of medication dose reductions in ER/PR-positive HER2-negative metastatic breast cancer patients receiving first-line therapy with a CDK4/6 inhibitor in combination with endocrine therapy. The study’s Principal Investigators are Mariya Rozenblit, MD, Assistant Professor of Medicine (Medical Oncology), and Lajos Pusztai, MD, PhD, Professor of Medicine (Medical Oncology), at Yale School of Medicine and Yale Cancer Center.
Taking more than one medication at a time, is very common in patients with cancer and can lead to poor treatment effectiveness by reducing treatment drug concentration levels. Drug dose reductions of CDK4/6 inhibitors to manage side effects are also common and may impact the efficacy of the drug in some patients. Circulating TKa has previously been identified in several studies as a predictor of therapy efficacy in metastatic breast cancer.
The study will use DiviTum TKa to measure TKa in “real time” from patient serum samples obtained during routine monitoring blood draws. All patients will be assessed for medication compliance, potential drug-drug interaction issues, and dose reductions. Counseling and optimization of concurrent medications will be conducted if an issue is identified. Changes in TKa levels will be analyzed for correlation with improved CDK4/6i response, duration on therapy and potentially better outcomes following medication interventions. The targeted number of participants is 120 patients, and the study duration is expected to be 12 to 18 months.