Phase III SELECT study of Lenvima (lenvatinib) in thryoid cancer published in the Journal of Clinical Oncology.-Eisai.

Eisai announced an analysis of data on treatment with Lenvima (lenvatinib) in thryoid cancer has been published in the Journal of Clinical Oncology. Results fro the phase III SELECT study show that treatment resulted in a statistically significant improvement in overall survival (OS) for patients older than 65 years of age with radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC) when compared with placebo, despite crossover of placebo patients to lenvatinib after progressive disease. The OS results demonstrate the efficacy of lenvatinib for older patients and indicate the association between age and poorer survival outcomes is diminished by treatment with lenvatinib.

Progression-free survival (PFS) and objective response rate (ORR) benefits were also maintained in patients treated with lenvatinib regardless of age group as compared with placebo. Results of safety analyses by subgroup demonstrated that toxicity with lenvatinib was manageable for most patients, including older patients, and dose modification and discontinuation of lenvatinib was more common for older patients. Specifically, median OS was reached only in the older placebo-treated patients (18.4 months) � survival data was not mature in the younger patient group � and younger patients who received placebo had statistically significantly longer OS than older patients who received placebo, demonstrating the known effect of age on prognosis. Despite this, overall survival was not significantly different between age groups for patients who were treated with lenvatinib.

Additionally, older patients who received lenvatinib experienced a statistically significant improvement in OS as compared with older patients who received placebo. These data further support that treatment with lenvatinib lessened the effect of age as a predictor of poorer survival. In addition, this analysis showed the PFS benefit of lenvatinib versus placebo was maintained in both age groups (younger patients: median PFS 20.2 vs. 3.2 months; older patients: 16.7 vs. 3.7 months and treatment with lenvatinib resulted in better ORR compared with placebo regardless of age. While treatment-related adverse events (AEs) were recorded for nearly all patients, the incidence of severe (grade 3 or higher) treatment-related AEs was significantly higher in older patients than in younger patients (89% and 67%, respectively) and older patients were more likely to experience AEs that required dose modifications.

See: "Effect of Age on the Efficacy and Safety of Lenvatinib in Radioiodine-Refractory Differentiated Thyroid Cancer in the Phase III SELECT Trial," Marcia S. Brose et al. Journal of Clinical Oncology 35, no. 23 (August 2017) 2692-2699. DOI: 10.1200/JCO.2016.71.6472