Eisai to highlight data from lenvatinib trials for uHCC and RCC
Japanese pharmaceutical company Eisai is planning to present data from the clinical trials of its drug candidate lenvatinib at the European Society for Medical Oncology (ESMO) 2017 Congress to be held in Madrid, Spain, between 8-12 September.
Lenvatinib is an oral multikinase inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor-alpha, RET and KIT proto-oncogenes.
At the conference, the firm will highlight health-related quality of life and disease symptoms data from lenvatinib’s Phase III REFLECT trial conducted in unresectable hepatocellular carcinoma (uHCC) patients.
The international, multi-centre, open-label, randomised, non-inferiority REFLECT trial compared the efficacy and safety of 12mg or 8mg once-daily lenvatinib with 400mg twice-daily sorafenib as a first-line systemic treatment in patients with uHCC.
Performed at 177 sites in 21 countries, the trial’s primary endpoint was overall survival, while secondary endpoints included progression-free survival, time to progression and objective response rate.
Lenvatinib was previously reported to have demonstrated overall survival by statistical confirmation by non-inferiority to sorafenib.
Based on the results from this trial, Eisai has submitted marketing authorisation to the European Medicines Agency (EMA).
The firm will also present data from a Phase Ib/II trial that assessed lenvatinib in combination with pembrolizumab in patients with renal cell carcinoma (RCC).
The results from this trial are reported to have indicated encouraging anti-tumour activity and safety with the combination therapy.
In addition to lenvatinib, the firm intends to present data from various trials of its oncology portfolio.
Eisai oncology business group chief commercial officer, EMEA chairman and CEO Gary Hendler said: “The breadth of data highlights our commitment to oncology and the discovery and development of innovative therapies from our portfolio that can make a difference and impact the lives of patients and their families.”