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Clinical Trials

Date: 2016-06-21

Type of information: Publication of results in a medical journal

phase: preclinical

Announcement: publication of results in the British Journal of Cancer

Company: Eisai (Japan)

Product: Halaven® (eribulin)

Action mechanism:

mitotic inhibitor/tubulin binder. Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane. Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.

Halaven® (eribulin) is currently indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. 

Disease: advanced breast cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

* On May 12, 2016, Eisai annouced that new data published in the British Journal of Cancer validate the distinct vascular remodelling activity of Halaven® (eribulin) compared to bevacizumab in breast tumour tissue. Optical imaging techniques for haemodynamic analysis and blood tests for biomarker analysis show that eribulin increases the oxygen saturation of breast tumour tissue and suppresses TGF-1, a driver of cancer progression associated with poor outcomes for women with advanced breast cancer. Haemodynamic analysis shows that oxygen saturation levels increase on day seven after treatment with eribulin (p=0.04) while deoxy-haemoglobin concentrations decrease (p=0.01). This trend was not observed for bevacizumab. There was no change in oxygen saturation at day seven (p=0.02), but instead a significant decrease in the concentration of oxy-haemoglobin (p=0.0003) for bevacizumab.
Results of the biomarker analyses show that both eribulin and bevacizumab decrease blood concentrations of VEGF and bFGF. A significant decrease in blood TGF-?1 concentrations is seen in patients treated with eribulin but not bevacizumab (p=0.002).] These findings clearly indicate that the mechanism of action of these two agents differs.
In the study, women with Stage 3/4 breast cancer were assigned either eribulin (n=14) or single-agent bevacizumab (N=15). To determine the change in the oxygenated breast tumour tissue, concentrations of oxy-haemoglobin, deoxy-haemoglobin and oxygen saturation were measured using Diffuse optical spectroscopic imaging (DOSI), prior to and seven days after the first infusion. Blood samples were collected for biomarker studies (VEGF, bFGF, and TGF-?1).

Is general: Yes