UPPSALA, SWEDEN / ACCESSWIRE / May 30, 2024 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) Biovica, active in cancer diagnostics, today announces that results with DiviTum® TKa from the Spanish GEICAM/2014-12 FLIPPER trial will be presented at the world's largest cancer conference, the annual ASCO meeting on June 2, 2024 9:00 AM - 12:00 PM CDT. The data supports the use of DiviTum TKa to predict outcome and progression on first line treatment HR+ metastatic breast cancer (MBC) patients providing important clinical information about treatment benefit.
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)
Contact
Anders Rylander, CEO
Phone: +46 76 666 16 47
E-mail: anders.rylander@biovica.com
Anders Morén, CFO
Phone: +46 73 125 92 46
E-mail: anders.moren@biovica.com
Biovica - Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica's assay, DiviTum® TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica's vision is: "Improved care for cancer patients." Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum® TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica's shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser. For more information, please visit: www.biovica.com
Attachments
DiviTum® TKa results to be presented at ASCO the world's largest cancer conference
SOURCE: Biovica International
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