Data Presented at the 15th International Thyroid Congress Provides Further Evidence for Lenvatinib in People with Advanced Thyroid Cancer

HATFIELD, England, October 20, 2015 /PRNewswire/ --

Lenvima(R) (lenvatinib) demonstrates clinically significant progression-free survival in people with advanced thyroid cancer across most of the common sites of metastases  


Data show Lenvima(R) (lenvatinib) improves progression-free survival for people with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC) regardless of metastatic site, with the exception of the brain.[1] These lenvatinib Phase III SELECT trial sub-analyses were presented at the 15th International Thyroid Congress (ITC) in an oral session on Monday 19 October.

The sub-analysis observed response rates of more than 50% and a progression-free survival benefit among people treated with lenvatinib with common sites of metastasis (bone, liver, lung, lymph node).[1] The study examined 392 patients being treated with lenvatinib vs placebo, and identified metastatic subgroups as an important determinant of progression-free survival for people treated with lenvatinib.

Lenvatinib is currently indicated in Europe for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).[2]

"These encouraging survival data confirm lenvatinib's efficacy profile across different patient sub-populations and metastatic sites. These data also suggest that people with advanced thyroid cancer should be treated with lenvatinib after the development of metastases in order to experience the significant progression-free survival benefit," comments Professor Martin Schlumberger, M.D. Institut Gustave Roussy, University Paris Sud, Paris, France.  

A second analysis of the Phase III SELECT study at ITC 2015 demonstrates that lenvatinib maintains progression-free survival irrespective of body mass index, as seen in a sub-analysis of three patient groups: under-and-normal weight (65 years), region and less than or equal to1 prior VEGFR-targeted therapies and randomised 2:1 to either lenvatinib or placebo therapy (24mg/d, 28-d cycle). The primary endpoint was PFS assessed by independent radiologic review. The 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. Median OS has not yet been reached.

The six most common lenvatinib treatment-related adverse events (TRAEs) of any grade were hypertension (67.8%), diarrhea (59.4%), fatigue (59.0%), decreased appetite (50.2%), weight loss (46.4%) and nausea (41.0%). TRAEs of Grade 3 or higher included hypertension (41.8%), proteinuria (10.0%), weight loss (9.6%), diarrhoea (8.0%), and decreased appetite (5.4%).

About Thyroid Cancer 

Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.[13] It is more common in women than in men and most are in their 40s or 50s at time of diagnosis.[14]

Thyroid cancer affects more than 52,000 people in Europe each year.[15] The incidence of thyroid cancer has increased significantly in the last decade by 69% and 65% in men and women, respectively. The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 90% of all cases.[9] The remaining cases are classified as either medullary (5-7% of cases) or anaplastic (1-2% of cases).[16]

RAI Refractory-DTC is a rare, difficult-to-treat type of cancer, characterised by aggressive growth and spread. While most DTC patients are curable with surgery and radioactive iodine treatment, the prognosis for those patients who do not respond is poor. [15] There are limited treatment options for this life-threatening and treatment-refractory form of thyroid cancer.[16]

About Eisai Co., Ltd. 

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology. 

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit  

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2. SmPC Lenvima (updated June 2015). Available
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Patients With Radioiodine-refractory Thyroid Cancer From the SELECT Trial. 15th
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Hypertension in the SELECT Trial. 15th International Thyroid Congress 2015, October
9 . Thyroid Cancer Basics. 2011. Available at: Accessed: October
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Revealed by Biochemical Characterization. ACS Med. Chem. Lett 2015; 6:89-94 
11. Wu P et al. Small-molecule kinase inhibitors: an analysis of FDA-approved drugs.
Drug Discovery Today 2015; 1-6 
12 . Schlumberger M, et al. Relationship Between Thyroid-Stimulating Hormone Levels and
Outcomes from the Randomized, Double-Blind, Phase 3 Study of (E7080) Lenvatinib in
Differentiated Cancer of the Thyroid (SELECT). Available at: Accessed: October
13. Brito J et al. BMJ 2013; 347 
14. Cabanillas ME, Dadu R. Optimizing therapy for radioactive iodine-refractory
differentiated thyroid cancer : Current state of the art and future directions.
Minerva Endocrinol. 2012 Dec; 37(4):335-356. 
15 . EUCAN 2015.
Accessed: October 2015 
16. Pacini F et al. ESMO Guidelines Working Group. Ann Oncol. 2012;23 (suppl


Date of preparation: October 2015 
Job code: Oncology-UK0064 



CONTACT: Media Enquiries: Eisai, Cressida Robson / Ben Speller, +44(0)7908314 155 / +44(0) 7951 078 795, / ; Tonic Life Communications, Alex Davies / EmmaCoughlan, +44 (0)7720 496 472 / +44(0) 7772 534 646,

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