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Eisai: Lenvatinib meets PFS endpoint in radioiodine-refractory differentiated thyroid cancer
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The investigational multitargeted tyrosine kinase inhibitor lenvatinib significantly improved PFS compared with placebo in patients with radioiodine-refractory differentiated thyroid cancer, the drug’s manufacturer announced today.
The SELECT trial — a randomized, double blind, placebo-controlled phase 3 study — included 392 patients with radioiodine-refractory differentiated thyroid cancer who had radiographic evidence of disease progression within the previous 12 months.
Patients received 24 mg oral lenvatinib (E7080, Eisai Inc.) once daily or placebo.
The study met its primary endpoint of PFS, company officials said. The five most common adverse events were hypertension, diarrhea, decreased appetite, weight loss and nausea, according to preliminary safety analyses.
The results “show the potential role of the investigational drug lenvatinib in this rare, hard-to-treat cancer,” Kenichi Nomoto, PhD, president of the Oncology Product Creation Unit at Eisai Product Creation Systems, said in a press release. “Radioiodine-refractory differentiated thyroid cancer remains an unmet need with a limited number of treatment options.”
In December 2012, the FDA granted orphan drug designation to lenvatinib for treatment of follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer.