Biovica International

The study, which is the first placebo-controlled study for DiviTum TKa, analyzed thymidine kinase activity (TKa) levels using the DiviTum TKa test in 189 patients treated with either the endocrine therapy fulvestrant plus the CDK4/6 inhibitor palbociclib versus fulvestrant plus placebo. After the SWOG study, this study is the second largest with DiviTum TKa with 910 plasma samples collected at baseline and every three months during treatment for the first year of therapy. The study investigators conclude that:

• Low Baseline (BL) DiviTum TKa values predict better progression-free survival (PFS) and overall survival (OS).
• Higher TKa at BL and at 12 weeks was detected in patients that progressed before 12 months.
• At progression, patients on fulvestrant plus palbociclib tended to have higher TKa levels than fulvestrant plus placebo, reflecting faster-growing tumors.
• High TKa at BL predicted shorter OS in the fulvestrant plus palbociclib arm.

“The results confirm DiviTum TKa’s ability to monitor and predict outcomes in first line treatment of HR+ MBC patients, enabling more informed treatment decisions. It is very gratifying that DiviTum TKa continues to perform so reliably with different types of combination treatments with CDK4/6 inhibition in first-line MBC monitoring, for the benefit of patients and for increased clinical use of DiviTum TKa,” said Anders Rylander, CEO of Biovica.

“As a commercial partner to Biovica in Spain and Portugal, I am excited that a Spanish oncology group is publishing such strong and promising results with the new biomarker DiviTum TKa. Our oncology unit is dedicated to precision oncology solutions, ensuring the best outcomes for cancer patients. DiviTum TKa demonstrates its ability to predict patient outcomes, which could lead to earlier changes in treatment and better patient management,” said Bahdja Benkherouf, Oncology Unit Manager at Biovica’s partner Palex.

Link to study: 10.1200/JCO.2024.42.16_suppl.1028
Ref. J. Albanell, et al, J Clin Oncol 42, 2024 (suppl 16; abstr 1028)