Biovica’s DiviTum®TKa in early treatment resistance trial

DiviTum®TKa has been selected to be included in the new prospective clinical study TIRESIAS, with the aim of investigating if DiviTum®TKa can be used to identify early resistance to treatment by a CDK4/6 inhibitor in combination with an aromatase inhibitor in breast cancer patients.

TIRESIAS is a multi-center study that will collect samples from 150 patients with hormone receptor positive metastatic breast cancer who receive the first-line standard treatment: a CDK4/6 inhibitor and an aromatase inhibitor. The aim is to demonstrate that DiviTum®TKa can predict progression free survival and clinical benefit from samples taken as early as two weeks into treatment.

“Our study aims to show that the use of DiviTum®TKa as early as two weeks into therapy, can predict treatment response and also early identify treatment resistance. We have previously studied DiviTum®TKa in this setting and documented its ability to predict outcome of CDK4/6 inhibitors, and we look forward to the results of this prospective study designed to bring important clinical data to the medical community for clinical use of DiviTum®TKa for these patients,” said Dr. Luca Malorni, Prato Hospital and Principal Investigator of the study.

“About one out of seven metastatic breast cancer patients starting this type of treatment receive virtually no benefit from the therapy. Today, evidence that the therapy is not working is often not seen until three to six months into treatment, which is unfortunate. We are excited that DiviTum®TKa will be a part of a study that may point the way toward an improvement in the current standard of care,” said Anders Rylander, CEO of Biovica.

Link to study https://www.clinicaltrials.gov/ct2/show/NCT04660435