Eisai's lenvatinib shows statistically-significant progression-free survival in Ph III trial

Japanese drug major Eisai (TYO: 4523) has published results of its SELECT Phase III study, showing its lenvatinib (E7080) demonstrated a statistically-significant extension in progression-free survival in progressive radioiodine-refractory differentiated thyroid cancer compared to placebo.

The median progression-free survival in the lenvatinib arm was 18.3 months, versus 3.6 months in placebo. Lenvatinib also showed a statistically-significant improvement in response rate compared to placebo (64.8% in lenvatinib, 1.5% in placebo). Complete response was observed in 1.5% of lenvatinib patients and zero in the placebo group.

The most common lenvatinib treatment-related adverse events of any grade, which occurred in more than 40% of patients in the lenvatinib group, were hypertension (67.8%), diarrhea (59.4%), fatigue or asthenia (59.0%), decreased appetite (50.2%), weight loss (46.4%) and nausea (41.0%).