Eisai, a Japan-based pharmaceutical company, has revealed results from study 211 evaluation of LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor discovered by the company, at two starting doses: the FDA-approved dose of 24mg once daily compared to a lower dose of 18mg once daily, in patients with radioactive iodine-refractory differentiated thyroid cancer, it was reported on Friday.

The data from the study revealed that the lower starting dose of the product did not meet the threshold for noninferiority compared to the FDA-approved starting dose and the safety profile in both arms was comparable with the known profile of LENVIMA for these patients. The findings were revealed in an e-poster session at the European Society for Medical Oncology Asia (ESMO ASIA) Virtual Congress 2020 (Abstract #426P).

During the phase two, multicentre, randomised, double-blind study (NCT02702388), 152 patients with RAI-refractory differentiated thyroid cancer were randomised to receive a daily oral dose of either 24mg or 18mg of the product. The aim of the study was to assess if a lower starting dose of LENVIMA (18mg) offered comparable efficacy with an improved safety profile compared to the product's approved 24mg starting dose. The main efficacy endpoint was noninferiority of the product 18mg compared to 24mg for objective response rate at Week 24 (ORRWK24) based on investigator evaluation per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. The primary safety endpoint was the occurrence of any more than Grade three treatment-emergent adverse events (TEAEs) within 24 weeks after randomisation.