“The results support that serum TK activity can be a biomarker to identify those patients who will have an adverse outcome to the treatment with fulvestrant in combination with palbociclib, which represents the most current and active treatment standard for patients with metastatic, endocrine resistant estrogen receptor positive and HER2 negative breast cancer. TK activity measured after only two weeks of therapy gives us a strong indication on the clinical outcome independently from other clinical parameters. Even though further investigation in prospective comparative trials is warranted, these results are highly encouraging and highlight the potential of DiviTum®TKa to evaluate treatment efficacy already during the first weeks of therapy, and afterwards to monitor the disease.”, said
“We are very proud to see the strong DiviTum®TKa results being published in EJC and want to thank IBCSG, BIG,
As previously announced, results demonstrate that after two weeks of therapy, patients whose TK levels are suppressed, have a significantly better progression free survival six months from treatment start. The study investigators conclude that a high pre-treatment baseline TKa level and an incomplete suppression of TKa during the first treatment cycle can identify patients with poor prognosis and primary resistance to fulvestrant and palbociclib. The results strongly support a role for DiviTum®TKa as a patient stratification and monitoring tool. Serum TKa has an advantage over ctDNA-based approaches in being a technologically smoother and cheaper approach, with results obtainable in virtually every patient.
The PYTHIA study
PYTHIA (IBCSG 53-14/BIG 14-04; NCT02536742) is a downstream trial of the AURORA platform (BIG 14-01; NCT02102165) that started in 2015 at 19 centers in
The PYTHIA study is the first prospective study in which DiviTum®TKa was assessed to address its capacity as a tool for early prediction of treatment efficacy for women with metastatic breast cancer. The study was conducted by the
The results of the PYTHIA study were first presented at the world´s leading breast cancer conference, SABCS, in early
The EJC is the official journal of the
Link to article: https://www.sciencedirect.com/science/article/pii/S0959804922000028?dgcid=coauthor
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