Biovica, verksamt inom blodbaserad cancerövervakning, meddelar att sju sammandrag baserade på studier med blodprovet DiviTum TKa kommer att presenteras vid världens största bröstcancermöte, San Antonio Breast Cancer Symposium (SABCS) den 10-13 december 2024. Två av dessa abstracts validerar DiviTum TKa i adjuvansmiljön (tidig bröstcancer), vilket kommer att öppna en ny marknadsmöjlighet för Biovica och som ökar marknadspotentialen inom bröstcancer med $3BUSD/år på nyckelmarknader (USA, Europa och Japan).
Dessa nya resultat förstärker hur DiviTum TKa-testet har värde som ett monitorerings- och prediktivt test för hormonreceptorpositiva (HR+) patienter med både metastaserad och tidig bröstcancer (adjuvant) behandlade med CDK4/6-hämmare, den mest förskrivna läkemedelsklassen för detta patientpopulationen.
"SABCS-symposiet är ett utmärkt tillfälle att dela de fantastiska resultaten som uppnåtts i kliniska spår med DiviTum TKa och ger exponering för cirka 11 000 deltagare. I år med ett rekord på sju abstracts. Vi är också mycket glada över de starka adjuvansdata (tidig bröstcancer), vilket indikerar en stor marknadspotential för oss plus möjligheten att förbättra vården för ännu fler bröstcancerpatienter", säger Anders Rylander, vd för Biovica.
| Abstract Title |
Institution |
Patient Population |
Key Findings |
| “Interrogating serum thymidine kinase activity with CDK4/6 inhibitor-based therapies: real-world experience in the metastatic and adjuvant setting.” |
Roswell Park, US |
HR+ MBC 1ST LINE HR+ ADJUVANT BC ABEMA |
TKa is predictive in adjuvant BC
• An on therapy TKa level of <50 DuA is predictive for a >20 month response to therapy in CDK4/6i treated pts diagnosed with HR+ MBC
• An on-therapy TKa level of >243 is predictive for <8 months of response to therapy
• Adjuvant BC pts treated with abemaciclib had a highly significant reduction in TKa between BL and C1/C2
• Elevated TKa levels were observed with disease recurrence |
| “Evaluation of proliferation biomarker serum thymidine kinase activity and prediction of early relapse in HR-positive HER2 negative high-risk early breast cancer: Analysis from the PENELOPE-B trial.” |
The German Breast Cancer Group, Germany, and US |
HR+ ADJUVANT BC PALBO |
TKa is prognostic in adjuvant BC
• In PENELOPE-B, BL TKa values >250 DuA were prognostic for early relapse within the 1st year of adjuvant therapy
• CPS-EG scores, in contrast, were not prognostic.
• Pts with early disease relapse also had an increase in TKa levels at the time of recurrence. |
| “ctDNA and serum thymidine kinase activity as tools to stratify ER+/HER2- metastatic breast cancer patients treated with endocrine therapy and CDK4/6 inhibitors: preliminary results of the TIRESIAS trial.” |
Hospital of Prato, Italy |
HR+ MBC 1ST LINE |
TKa offers an attractive alternative to ctDNA
• Circulating tumor DNA (ctDNA) and thymidine kinase activity (TKa) give complimentary information
• TKa and ctDNA dynamic changes are concordant
• TKa offers a cost-effective and easier alternative to ctDNA for non-invasive monitoring of early response to therapy |
| “Thymidine kinase activity as a prognostic biomarker for first-line CDK4/6 inhibitor efficacy in the Personalised Disease Monitoring in Metastatic Breast Cancer (PDM-MBC) Study.” |
Jönköping Hospital Sweden, Christie in Manchester, UK |
HR+ MBC 1ST LINE |
TKa levels are prognostic for CDK4/6i efficacy in HR+ MBC
• Baseline (BL) TKa >250 DuA associated with shorter PFS (13.5 mo vs not reached) and OS (30.3 vs 51.8 mo) in 1st line CDK4/6 inhibitor pts
• A TKa value >100 DuA at any cycle 1 timepoint (BL, D15, D28) predicted for a significantly worse PFS and OS vs staying below 100 DuA at all 3 timepoints. |
| “The Role of Serum Thymidine Kinase 1 (TK1) as a Prognostic Factor in Luminal HER2 Negative Breast Cancer.” |
IRBLeida, Spain |
HR+ Early breast cancer pre/post surgery
HR+ MBC 1ST LINE |
TKa is a prognostic biomarker in luminal BC
• EBC pts with high TKa also have a high OncotypeDx score.
• MBC pts who had an on-therapy increase in TKa had progression in 3-6 mo
• MBC pts who had an on-therapy decrease in TKa had a response lasting greater than 3-6 mo |
| “Thymidine kinase activity as a prognostic and predictive biomarker in the Phase II PACE trial of CDK4/6 inhibition beyond progression .” |
Dana Farber Cancer Institute, US |
HR+ MBC 2ND LINE – PALBO |
TKa can predict 2nd line CDK4/6i benefit
• There currently is no existing biomarker to predict the benefit to a CDK4/6i following progression on a previous CDK4/6i
• High C2D1 on-treatment TKa (>250 DuA) was associated with a lack of response to palbociclib beyond progression on a prior CDK4/6i
• Authors conclude TKa could facilitate clinical decisions in this context |
| “Thymidine kinase activity as a predictive biomarker for benefit to a second line CDK4/6 inhibitor: analysis from the MAINTAIN trial. |
Emory, US |
HR+ MBC 2ND LINE RIBO |
TKa can predict 2nd line CDK4/6i benefit
• TKa levels on C2D1 significantly predicted for the benefit to ribociclib after progression on a prior CDK4/6i
• TKa <250 DuA had a PFS of 10.9 mo on ribociclib
• TKa >250 DuA had a PFS of 2.7 mo on ribociclib |
Lista över forkortningar:
ABEMA CDK4/6-hämmaren från Eli Lilly kallas Abemaciclib
BC Bröst Cancer
BL Base Line – prov taget innan behandling
C1 behandlingscykel 1
C2 behandlingscykel 2
C2/D1 behandlingscykel 2, dag 1
CDK4/6i CDK4/6-hämmarbehandlingar
CPS-EG score: The CPS (Clinical and Pathological Score) + EG (Estrogen and Grade) scoring system
ctDNA circulating tumor DNA
D15 Dag 15
D28 Dag 28
DuA DiviTum units of activity
EBC tidig breast cancer
HER2 Human Epidermal growth factor Receptor 2
HR Hormon receptor
HR+ Hormon receptor-positiv
MBC Metastatisk bröst cancer
mo månader
OS overall survival (överlevnad)
PALBO CDK4/6-hämmaren från Pfizer som heter Palbociclib
PFS progressionsfri överlevnad
Pts Patienter
RIBO CDK4/6-hämmaren från Novartis kallas Ribociclib
TKa Tymidinkinasaktivitet