DiviTum(R) TKa Results to be Presented at ASCO Cancer Conference

UPPSALA, SWEDEN – Biovica International, a company specializing in cancer diagnostics, has announced that findings from the GEICAM/2014-12 FLIPPER trial involving its DiviTum® TKa test will be showcased at the prestigious American Society of Clinical Oncology (ASCO) annual meeting on June 2, 2024. This study provides critical insights into the efficacy of DiviTum® TKa in predicting outcomes and disease progression in patients with hormone receptor-positive metastatic breast cancer (HR+ MBC).

The GEICAM/2014-12 FLIPPER trial is notably the first placebo-controlled study evaluating DiviTum® TKa. The trial involved 189 patients who were treated with either a combination of the endocrine therapy fulvestrant and the CDK4/6 inhibitor palbociclib, or fulvestrant and a placebo. Researchers measured thymidine kinase activity (TKa) levels using the DiviTum® TKa test at the start of the treatment and every three months during the first year.

Key findings from the study include:
- Lower baseline DiviTum® TKa levels were associated with improved progression-free survival (PFS) and overall survival (OS).
- Patients who exhibited higher TKa levels at baseline and at the 12-week mark were more likely to experience disease progression within 12 months.
- Among patients who progressed, those on the fulvestrant and palbociclib combination had higher TKa levels compared to those on fulvestrant and placebo, suggesting more aggressive tumor growth.
- High baseline TKa levels predicted shorter overall survival in patients treated with the fulvestrant and palbociclib combination.

Anders Rylander, CEO of Biovica, emphasized the significance of these results, stating, "The findings confirm DiviTum® TKa's utility in monitoring and predicting outcomes for HR+ MBC patients, facilitating more informed treatment decisions. It is gratifying that DiviTum® TKa continues to demonstrate reliability across various combination treatments involving CDK4/6 inhibitors, ultimately benefiting patients and expanding its clinical use."

The study's promising results were also highlighted by Bahdja Benkherouf, Oncology Unit Manager at Palex, Biovica's partner in Spain and Portugal. Benkherouf expressed excitement about the publication of these results by a Spanish oncology group, noting that DiviTum® TKa's ability to predict patient outcomes could lead to earlier treatment adjustments and improved patient management.

DiviTum® TKa, developed by Biovica, is a blood-based biomarker assay designed to measure cell proliferation by detecting thymidine kinase activity in the bloodstream. This assay has demonstrated its potential in providing insights into treatment effectiveness in various clinical trials. The primary application of DiviTum® TKa is for monitoring the treatment of metastatic breast cancer patients.

Biovica's mission is to enhance cancer patient care through its innovative diagnostic solutions. The company collaborates with leading cancer institutes and pharmaceutical firms worldwide. DiviTum® TKa has received FDA 510(k) clearance in the United States and is CE-marked in the European Union. Biovica's shares are listed on the Nasdaq First North Premier Growth Market under the ticker BIOVIC B.

As Biovica continues to advance its diagnostic tools, the presentation at ASCO 2024 marks a significant step in showcasing the clinical value of DiviTum® TKa in oncology, reinforcing its role in improving patient outcomes and informing treatment strategies.

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