Study: Angiopoietin-2 Levels May Predict Lenvatinib Response

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A new analysis from the phase III SELECT trial of lenvatinib in the treatment of radioiodine-refractory differentiated thyroid cancer shows that the level of baseline angiopoietin-2 may be a predictive factor for lenvatinib response, tumor shrinkage and prolonged progression free survival. Angiopoietin-2 regulates the formation tumor blood vessels.

A second subgroup analysis from SELECT shows a statistically significant correlation between hypertension and PFS in people with radioiodine-refractory differentiated thyroid cancer. The analyses were presented at the European Society for Medical Oncology 2014 Congress.

Hypertension is a known adverse event of vascular endothelial growth factor receptor inhibition and a biomarker for tyrosine kinase inhibitor efficacy in renal cell carcinoma treatment. In the SELECT study, 73 percent of lenvatinib treated patients experienced hypertension.

“To date, there are no established prognostic or predictive biomarkers for radioiodine-refractory differentiated thyroid cancer or its treatment, so these studies are crucial in helping to understand further this disease and the best approach to treatment,” said Lori Wirth, assistant professor of medicine at Harvard Medical School and medical director of the Center for Head and Neck Cancers at Massachusetts General Hospital.

“Although hypertension is a significant adverse event that must be carefully monitored and managed, it may be an important indicator of the efficacy of treatments such as lenvatinib,” she said. “Further studies are needed to investigate hypertension as a predictive indicator of lenvatinib response so that people with radioiodine-refractory differentiated thyroid cancer can be managed appropriately to ensure they get the most out of their treatment.”

A third subgroup analysis characterized the change in tumor size in radioiodine-refractory differentiated thyroid cancer. Patients who received lenvatinib treatment for one year or more saw a rapid tumor shrinkage in the first eight weeks of treatment, followed by a slower, continuous shrinkage.

Other data showed that the PFS benefit with lenvatinib compared to placebo observed in the overall study population was maintained in all subgroups examined, including patients with papillary and follicular thyroid cancer.

Lenvatinib, sponsored by Eisai Inc., is an oral multiple receptor tyrosine kinase inhibitor with a novel binding mode that selectively inhibits the kinase activities of all vascular endothelial growth factor receptors, in addition to other proangiogenic and oncogenic pathway-related TKIs including all fibroblast growth factor receptors, the platelet-derived growth factor receptor PDGFRalpha, KIT and RET that are involved in tumor proliferation.

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