DiviTum®TKa Monitoring Capabilities Confirmed in SWOG Study
Biovica, active in cancer diagnostics, today announced that new DiviTum®TKa results from a large SWOG Cancer Research Network study further strengthen DiviTum®TKa’s monitoring capabilities within metastatic breast cancer. The study, known as S0226, showed impressive data on progression free survival and overall survival. Furthermore, results support that DiviTum®TKa can predict benefit from metastatic breast cancer therapy. The new results will be presented at the world’s leading breast cancer conference, the San Antonio Breast Cancer Symposium, in December.
“We appreciate our collaboration with SWOG and are glad to see the study presented at the world´s leading breast cancer conference. The results from this large data set are highly encouraging and significantly expand the evidence base for DiviTumTKa. The data supports the intended use of DiviTumTKa as submitted for FDA approval, but also introduces a new possible prediction capability. We look forward to providing DiviTum®TKa for the benefit of patients with metastatic breast cancer,” said Anders Rylander, CEO of Biovica.
In the study, DiviTum®TKa was used to analyze over 1700 samples from more than 400 patients from the start of treatment and at four different timepoints during care. Large differences were observed in median progression free survival (11 vs. 17 months) and overall survival (30 vs. 58 months) between patients with high vs. low DiviTum® TKa baseline values. These differences were maintained at each of the treatment serial monitoring timepoints.
The study also showed that for patients without prior endocrine treatment and high DiviTum® TKa values, overall survival was significantly longer for patients treated with combination endocrine treatment vs. monotherapy. This supports a predictive capacity of DiviTum®TKa when selecting therapy for metastatic breast cancer patients.
“Our study demonstrates that measuring TK activity provides important information when evaluating and selecting therapy for patients with metastatic breast cancer. The results from this large data set support previous findings that DiviTum®TKa provides accurate prognosis and monitoring of progression free survival and overall survival for these patients. We look forward to continue our collaboration with Biovica to improve the lives of women with metastatic breast cancer,” said Costanza Paoletti, M.D. principal investigator of the study.
The study is the largest study to evaluate DiviTumTKa for prognostic and serial monitoring of metastatic breast cancer. The study is the foundation of the DiviTum®TKa clinical validation submitted to the FDA on September 25, 2020.
New DiviTum®TKa results from the SWOG study will be presented at the San Antonio Breast Cancer Symposium, December 8-12, 2020.
SWOG Cancer Research Network SWOG is part of the National Cancer Institute’s (NCI) National Clinical Trials Network and the NCI Community Oncology Research Program, and is part of the oldest and largest publicly-funded cancer research network in the United States. SWOG has nearly 12,000 members in 47 states and six foreign countries who design and conduct clinical trials to improve the lives of people with cancer. SWOG trials have led to the approval of 14 cancer drugs, changed more than 100 standards of cancer care, and saved more than 3 million years of human life. Learn more at swog.org. This news release uses data that will be presented at the San Antonio Breast Cancer Symposium obtained from the S0226 study and does not necessarily reflect the opinions or views of SWOG or the NCI.
Biovica – Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays to evaluate efficacy of cancer treatments. Biovica’s assay DiviTum® measure cell proliferation by detecting a biomarker in the blood stream. The assay has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. The first application for DiviTum is monitoring of treatment for patients with metastatic breast cancer. Biovica's vision is that all cancer patients will get an optimal treatment from day one. Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum is CE-marked and registered with the Swedish Medical Products Agency. Biovica's shares are traded on the Nasdaq First North Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser, firstname.lastname@example.org, +46 8 528 00 399. For more information please visit: www.biovica.com.
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