The breakthrough status was based on the results from a Phase II clinical trial (Study 205) of lenvatinib in advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy.
In the trial, the combination of lenvatinib plus everolimus showed a significant extension in progression free survival (PFS), the study’s primary endpoint, compared to everolimus alone.
In addition, lenvatinib alone showed an extension in PFS compared to everolimus alone.
During the trial, both the lenvatinib plus everolimus group and the lenvatinib alone group showed an improvement in objective response rate compared to the everolimus alone group.
Additionally, an updated analysis carried out last December suggested that lenvatinib plus everolimus extends overall survival compared to everolimus alone.
Diarrhea, decreased appetite and fatigue were the most common treatment-emergent adverse events (TEAE) reported in the lenvatinib plus everolimus group, while the most common TEAEs of Grade 3 or higher included diarrhea, hypertension and fatigue.
According to the data from the Phase II Study 205, lenvatinib plus everolimus showed superior PFS over everolimus alone which is recommended by the National Comprehensive Cancer Network (NCCN) guidelines as a 2nd-line therapy for advanced or metastatic renal cell carcinoma.
The company said that no combination therapy is currently approved for this indication in the US, Europe or Japan.
Image: Eisai head office in Tokyo, Japan. Photo: courtesy of Arthena.