“We are very pleased that these results, which were initially presented at the AACR annual meeting 2019, are published in the renowned journal Clinical Cancer Research. The data shows that DiviTum^® can be used to evaluate the treatment efficacy of a CDK 4/6 inhibitor in metastatic breast cancer.” said Anders Rylander, CEO of Biovica. “This data is an important part of our clinical efficacy data. DiviTum^® has been evaluated in more than ten studies including more than 1 700 breast cancer patients”.

The TREND-study evaluated blood samples from 45 women with metastatic breast cancer treated with palbociclib with or without endocrine therapy. In the article “Plasma thymidine kinase activity as a biomarker in patients with luminal metastatic breast cancer treated with palbociclib within the TREnd trial”, researchers demonstrated that patients with decreasing levels of DiviTum^® after only one month of therapy have a significant better outcome than patients with increasing levels, 9 vs 3.2 months’ time to progression.

Hence, change in TK levels during treatment provides important and early information for assessing treatment response. DiviTum^® levels measured at the point of progression on palbociclib correlated with clinical outcome on the next line of systemic treatment.

“The results from these studies provide the first evidence for DiviTum^® as a biomarker of efficacy of palbociclib in metastatic breast cancer and build upon prior evidence in the pre-operative setting.” said Dr Luca Malorni, Prato Hospital, Italy, lead investigator of the study. “The results need confirmation in larger, ongoing studies, and are encouraging in terms of clinical value. Via this blood test we can potentially identify which patients will not have a benefit from these new treatments and should ideally be selected for alternative regimens.”

The Clinical Cancer Research publication can be found online at http://clincancerres.aacrjournals.org/cgi/content/abstract/1078-0432.CCR-19-3271.