Lenvatinib Phase III results show significant improvement in progression-free survival in people with Radioiodine-Refractory differentiated Thyroid Cancer

Pivotal phase III data for lenvatinib to be presented in a Head and Neck Cancer oral session at American Society of Clinical Oncology congress (ASCO) – Press Release.

Eisai announced pivotal results from the Phase III SELECT trial of lenvatinib (E7080) that investigated progression free survival (PFS) in people with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC). PFS with lenvatinib was extended significantly compared to placebo (Hazard Ratio (HR)=0.21, [99% CI, 0.14-0.31]; p<0.0001). The median PFS with lenvatinib and placebo were 18.3 months and 3.6 months, respectively.

The statistically significant PFS benefit for lenvatinib was confirmed in all predefined subgroups of the study.¹

The data was presented at the 50^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in a Head and Neck Cancer oral session (Abstract No. LBA6008), and as part of the official press programme.¹

Differentiated thyroid cancer is the most common form of thyroid cancer and accounts for approximately 90% of all thyroid cancers.²  Currently there are very few effective therapies for RR-DTC in Europe. Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors, in addition to other proangiogenic and oncogenic pathway-related RTKs involved in tumour proliferation.³ 

“These results show the benefit of lenvatinib in this rare, hard-to-treat cancer. Finding a treatment with positive phase III results for this aggressive form of thyroid cancer, where there are currently limited options, will be welcomed by physicians and patients all over the world,” commented Professor Martin Schlumberger, Primary Investigator and M.D. Institut Gustave Roussy, University Paris Sud, Paris, France.

PFS was the primary endpoint for this study. Secondary endpoints of the study included overall response rate (ORR), overall survival (OS) and safety. Rates of complete response were 1.5% (4 patients) for the lenvatinib group and zero in the placebo group. The results for partial response were 63.2% (165 patients) in the lenvatinib group and 1.5% (2 patients) in the placebo arm. The median exposure duration was 13.8 months for lenvatinib and 3.9 months for placebo and the median time to response for lenvatinib was 2.0 months.¹ Median OS has not yet been reached.

“Eisai is committed to understanding the potential role of lenvatinib in RR-DTC, an area of oncology with high unmet need. Eisai’s first thought is to patients and their families worldwide and these positive phase III results are an important advancement for patients and doctors alike,” said Kenichi Nomoto, PhD, President, Oncology Product Creation Unit, Eisai Product Creation Systems.

The five most common lenvatinib treatment-related adverse events (TRAEs) of any grade were hypertension, diarrhoea, decreased appetite, weight loss and nausea.¹

Other abstracts submitted to ASCO reported results for lenvatinib across a variety of tumour types including RR-DTC, non small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC).

Lenvatinib, discovered and developed by Eisai, was granted orphan drug designation (ODD) for the treatment of follicular and papillary thyroid cancer by the European Commission in April 2013. It also has ODD in the United States (U.S.) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer and in Japan for thyroid cancer. Based on these clinical results presented at ASCO, Eisai will submit marketing authorisation applications for lenvatinib to health authorities in the U.S., Japan and Europe.