Positive Phase III data on E 7080 for Thyroid Cancer-Eisai

Data from the Phase III Study (SELECT) of E 7080 (lenvatinib), from Eisai, show that Progression Free Survival (PFS) with lenvatinib is extended significantly compared to placebo 18.3 months vs 3.6 months, in people with progressive radioiodine-refractory differentiated Thyroid Cancer (RR-DTC). The SELECT study was a multicentre, randomised, double-blind, placebo-controlled Phase III study which compared the PFS of 392 patients with RR-DTC and radiographic evidence of disease progression within the prior 13 months, treated with once-daily, oral lenvatinib versus placebo. Exploratory subgroup analyses suggests that lenvatinib maintains PFS benefit in people with progressive RR-DTC including people with lung metastasis, median PFS: lenvatinib, 18.7 months; placebo, 3.6 months, and bone metastasis median PFS: lenvatinib, NR; placebo, 7.4 months.

A second subgroup analysis of the SELECT data finds that the PFS benefit is similar in 195 people in Europe with progressive RR-DTC (lenvatinib n=131 and placebo n=64) compared with the overall study population. The median PFS with lenvatinib and placebo is 18.7 months and 3.7 months respectively. The 5 most common treatment-related adverse events (any grade) in the European subgroup were hypertension (68%), diarrhoea (59%), decreased appetite (50%), decreased weight (46%) and nausea (41%). Data will be presented at the 38th Annual Meeting of the European Thyroid Association.