Phase III Trial Data: Lenvatinib Extends PFS by Over 14 Months

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In a phase III trial of patients with progressive radioiodine-refractory differentiated thyroid cancer, lenvatinib significantly extended progression-free survival compared to placebo.

The median PFS with lenvatinib and placebo were 18.3 months and 3.6 months, respectively (HR=0.21, [99% CI, 0.14-0.31]; p<0.0001). The benefit was confirmed in all predefined subgroups of the study.

The study, named SELECT, was presented at the annual meeting of the American Society of Clinical Oncology in a Head and Neck Cancer oral session June 2.

Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor receptors, in addition to other proangiogenic and oncogenic pathway-related RTKs involved in tumor proliferation.

SELECT was a multicenter, randomized, double-blind study to compare the PFS of patients with RR-DTC and radiographic evidence of disease progression within the prior 13 months, treated with once-daily, oral lenvatinib versus placebo. The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia.

PFS was the primary endpoint for this study, and secondary endpoints included overall survival, overall response rate and safety. Median OS has not yet been reached.

Rates of complete response were 1.5 percent (4 patients) for the lenvatinib group and zero in the placebo group. The results for partial response were 63.2 percent (165 patients) in the lenvatinib group and 1.5 percent (2 patients) in the placebo arm. The median exposure duration was 13.8 months for lenvatinib and 3.9 months for placebo, and the median time to response for lenvatinib was 2.0 months.

Lenvatinib, sponsored by Eisai, was granted orphan drug designation for the treatment of follicular and papillary thyroid cancer by the European Commission in April 2013. FDA granted orphan status for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer.

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In the early morning of April 30, 35 years ago, I was awakened by a call from Anatoly Dobrynin, a long-time Soviet Ambassador to the United States. He said General Secretary Mikhail Gorbachev wanted me to come to the Soviet Union to help treat victims of the Chernobyl nuclear power facility accident. I had cabled Gorbachev a few days earlier, offering my assistance. 

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