Eisai has reported results from the Phase II Study 211 of two doses of its orally available multiple receptor tyrosine kinase inhibitor, Lenvima, in patients with radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC).
The data showed that the once-daily lower starting dose, 18mg of Lenvima, did not meet the threshold for noninferiority as compared to the US Food and Drug Administration (FDA)-approved starting dose of 24mg.
The multi-centre, randomised, double-blind study enrolled 152 patients with RAI-refractory DTC, who were randomly given a daily oral dose of either 24mg or 18mg of Lenvima.
Its objective was to analyse whether the 18mg dose would provide comparable efficacy with an improved safety profile compared to the approved 24mg dose of Lenvima.
At week 24, primary efficacy analysis data showed that the objective response rate (ORR) was at 57.3% in the 24mg arm as compared to 40.3% in the 18mg arm.
The 18mg dose did not show noninferiority in efficacy to the 24mg dose, failing to meet the trial’s primary efficacy endpoint.
Primary safety analysis on the incidence of Grade 3 or higher treatment-emergent adverse events (TEAEs) within 24 weeks showed a non-clinically relevant difference of 4.2% between both the treatment arms.
About 61.3% of patients in the 24mg arm experienced TEAEs as compared to 57.1% in the 18mg arm.
Moreover, no new or unexpected safety signals have been noted during the trial.
Eisai Oncology Business Group vice-president, chief medicine creation officer and chief discovery officer Dr Takashi Owa said: “These investigational data reiterate that the approved dosing of Lenvima delivers a clinically significant benefit and consistent safety profile for patients with RAI-refractory DTC.
“It’s through studies like this we’re able to show our dedication to enhancing healthcare providers’ understanding of our medicines. This helps them to best serve patients with this difficult-to-treat cancer.”