Preliminary results from Eisai's lenvatinib Phase II trial in thyroid cancer to be presented at ASCO 2011

Preliminary results of a Phase II single-arm study to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting showed that Eisai's lenvatinib (USAN) demonstrated an Objective Response Rate (ORR) of 59% (34/58, 95% CI: 45-71), based on an updated investigator assessment, in patients with advanced radioiodine (RAI)-refractory differentiated thyroid cancer (DTC). These results will be presented during an ASCO oral session on June 6, 2011.

"These findings are important because there are limited treatment options for this difficult-to-treat, life-threatening and resistant form of thyroid cancer," said Steven Sherman, M.D., study investigator and Distinguished Professor of Endocrinology, Department of Endocrine Neoplasia and Hormonal Disorders at the University of Texas MD Anderson Cancer Center in Houston. "These results indicate that lenvatinib should be further evaluated in a definitive Phase III trial."

All enrolled patients reported at least one treatment-related adverse event. The most frequently reported treatment-related adverse events were: hypertension 74% (Gr: 3:10%), proteinuria 60% (Gr 3:10%), decreased weight 57% (Gr 3:7%), diarrhea 55% (Gr 3:10%) and fatigue 53% (Gr 3:7%). Toxicities were managed with dose reduction in 35% of patients and 23% were ultimately withdrawn from therapy due to toxicity.