DiviTum®TKa Ongoing Research

Ongoing research

DiviTum®TKa is being evaluated in several research studies to evaluate its performance in monitoring metastatic breast cancer and in other tumor types, in conjunction with a number of cell cycle regulating therapeutic regimens.

MONITORING ENDOCRINE THERAPIES

S0226
Investigators: SWOG

Serial blood samples from up to five time points from 432 postmenopausal women with HR+ metastatic breast cancer. The researchers will examine the outcomes and DiviTum® values to evaluate whether the assay can accurately predict treatment response in metastatic hormone receptor-positive breast cancer patients. SWOG Cancer Research Network is a cancer clinical trials network, funded by the US National Cancer Institute (NCI).

Results of the original S0226 study were published in the New England Journal of Medicine (Mehta R.S. et al 2012 and 2019).

MONITORING ET + CDK 4/6 INHIBITORS

PYTHIA
Investigators: IBCSG/BIG

PYTHIA is a prospective single arm, Phase II study by IBCSG/BIG with 124 post-menopausal women with HR+ metastatic breast cancer treated with fulvestrant + palbociclib. The researcher of the study aims to evaluate the combination therapy to see the association of progression-free survival with potential biomarkers. DiviTum® is used to measure TK levels in blood taken from patients before and during therapy to explore whether the assay results assist physicians in predicting response to therapy as well as in monitoring drug efficacy during treatment.

RESISTANCE TO AROMATASE INHIBITORS + CDK 4/6 INHIBITORS

Investigators: University of Nebraska and Washington University, St Louis

In this study, the investigators examine an alternative dosing schedule for Palbociclib in metastatic breast cancer. Additionally, they examine whether the alternative dosing schedule for Palbociclib inhibits sTK1 and whether sTK1 dynamics predicts PAL response.

EARLY PROGRESSION ON CDK 4/6 INHIBITORS

PROMISE
Investigators: Mayo Clinic

Researchers at the Mayo Clinic are carrying out the PROMISE trial to better understand early resistance (within 12 months) to the combination of endocrine therapy + palbociclib. The study includes 250 patients receiving either 1st line or 2nd line treatment. Blood samples for Divitum analysis are being taken at baseline, 2 months after start of treatment, and at disease progression. Other biomarkers are also being assessed. The main objective: Identify biomarkers & pathways associated with early progression.

MONITORING PALBOCICLIB + PACLITAXEL THERAPY

Investigators: University of Pennsylvania

Biovica is collaborating with oncologists at the University of Pennsylvania to measure thymidine kinase (TK) activity in serum samples from patients enrolled on a clinical trial of a CDK 4/6 inhibitor (ribociclib) and chemotherapy (paclitaxel). This project should provide useful information on the potential of DiviTum as a pharmacodynamic marker in patients receiving these therapies.

DETERMINANTS OF RESISTANCE TO FIRST-LINE THERAPY WITH AN AI AND PALBOCICLIB FOR HR+ MBC

Investigators: Johns Hopkins

The goal of this study is to determine if investigators can predict which patients will or will not respond to an aromatase inhibitor and palbociclib for metastatic breast cancer. Investigators will use information from the tumor tissue and serial blood samples. The hope is that a deeper understanding of which participants will respond to this combination and how resistance emerges will allow the investigators to better tailor therapies for metastatic breast cancer.

PERSONALIZED DISEASE MONITORING IN METASTATIC BREAST CANCER

Christie Hospital, UK

Despite personalized medicine being increasingly used for diagnosis and treatment, follow-ups still include radiology exams every 3-4 months, leading to many ‘unnecessary’ tests for patients with long-term stable disease. Tumor markers such as ctDNA, TK activity and CA15-3 may be useful for disease monitoring in the metastatic setting. Algorithms that accurately define time-points at which imaging can be foregone, or reinstituted when progression is forecast, have not been developed. The study will measure ctDNA, TK1 and CA15-3 at all imaging time-points. Cost-effectiveness of the biomarker protocol will also be evaluated.

NEOADJUVANT RESPONSE-GUIDED TREATMENT OF SLOWLY PROLIFERATING HORMONE RECEPTOR POSITIVE TUMORS (PREDIX LUMA)

Karolinska University Hospital, Sweden

This neoadjuvant trial evaluates efficacy and toxicity of palbociclib when added to standard endocrine treatment. Tissue (Ki67) and blood-based markers (TK activity) of cell proliferation are used to guide treatment decisions between endocrine treatment monotherapy and combination therapy with palbociclib.