The PROMISE Study is evaluating the use of genomics in correlation with TK activity (TKa) to improve monitoring of breast cancer treatment.

“We are developing increased knowledge regarding the use of genomics and TKa measurements as tools for potential early identification of tumor response and resistance when treating patients with hormone receptor positive, HER2-negative metastatic breast cancer,” said Ciara O´Sullivan, M.B, B.Ch. BAO, an oncologist at Mayo Clinic and principal investigator of the study.

For the study, researchers used DiviTum®TKa to analyze serum samples from patients with metastatic breast cancer collected pre-treatment and after two cycles of standard combination treatment of endocrine therapy and a CDK 4/6 inhibitor. The aim of the study is to analyze the predictive capacity of DiviTum®TKa to evaluate efficacy and provide a comprehensive genomic assessment in order to identify novel genomic variants and pathways associated with an early decline in TKa.

Sixty-three patients were enrolled on PROMISE, which closed to new patient accrual in July 2020. In this initial analysis of 32 patients, there was a difference in genomic expression depending on whether patients had high or low TKa levels. The pattern between TKa and individual patients’ genomic expression profiles may be important for future monitoring of metastatic breast cancer, with the goal of testing new therapeutic approaches to overcome resistance to CDK4/6 inhibitors and endocrine therapy. The study is ongoing and will report updated data from additional time points and greater numbers of patients in the future.

“We are excited to once again collaborate with the Mayo Clinic in this important study to increase knowledge about resistance mechanisms and using DiviTum®TKa together with other biomarkers in the monitoring of metastatic breast cancer,” said Anders Rylander, CEO of Biovica.