Abstract Name Session
Lenvatinib Abstracts
Outcomes by Site of Metastasis for Patients Poster #55
With Radioiodine-refractory Differentiated Oral presentation
Thyroid Cancer Monday, October 19 4:00 p.m. - 4:30 p.m.
Treated With Lenvatinib Versus Placebo: Poster: Monday, October 19
Results from a Phase 3, Randomized Trial 9:20 a.m. - 9:45 a.m.; 3:05 p.m.
- 4:00 p.m
Tuesday, October 20
9:20 a.m. - 9:45 a.m.
Habra M.
Lenvatinib and the Effect of Age on Overall Poster #731
Survival Poster presentation
for Patients With Radioiodine-refractory Wednesday, October 21
Differentiated Thyroid Cancer 9:20 a.m. - 9:45 a.m.; 3:05 p.m.
- 4:00 p.m.
Thursday, October 22
9:20 a.m. - 10:20 a.m.
Brose M.
Characteristics of Patients on Lenvatinib Poster #629
With Treatment-emergent Hypertension in the Poster presentation
SELECT Trial Wednesday, October 21
9:20 a.m. - 9:45 a.m., 3:05 p.m.
- 4:00 p.m.
Thursday, October 22
9:20 a.m. - 10:20 a.m
Rietschel P.
Efficacy and Safety of Lenvatinib by Body Poster #693
Mass Index in Patients With 131I-Refractory Poster presentation
Differentiated Thyroid Cancer From the Phase Wednesday, October 21
3 SELECT Study 9:20 a.m. - 9:45 a.m.; 3:05 p.m
- 4:00 p.m.
Thursday, October 22
9:20 a.m. - 10:20 a.m.
Tahara M.
Incidence and Timing of Common Adverse Events Poster #647
in Lenvatinib-treated Patients With Poster presentation
Radioiodine-refractory Thyroid Cancer From Wednesday, October 21
the SELECT Trial 9:20 a.m. - 9:45 a.m.; 3:05 p.m.
- 4:00 p.m.
Thursday, October 22
9:20 a.m. - 10:20 a.m.
Gianoukakis A.
Number-Needed-to-Treat (NNT) Analysis of Poster #670
Therapies In Radioiodine-refractory Poster presentation
Differentiated Thyroid Cancer (RR-DTC) Using Wednesday, October 21
Indirect Comparison 9:20 a.m. - 9:45 a.m.; 3:05 p.m.
- 4:00 p.m.
Thursday, October 22
9:20 a.m. - 10:20 a.m.
Tremblay G.
RAI-R DTC Quality of Survival Abstract
A Study of the Quality of Survival in Poster #231
Radioiodine Refractory Thyroid Cancer Poster presentation
Monday, October 19
Poster: Monday, October 19
9:20 a.m. - 9:45 a.m.; 3:05 p.m.
- 4:00 p.m.
Tuesday, October 20
9:20 a.m. - 9:45 a.m.
Taylor M.
Lenvatinib has been approved for the treatment of refractory thyroid cancer in the United States, South Korea, Europe and Japan, and has been submitted for regulatory approval in Switzerland, Canada, Singapore, Russia, Australia and Brazil. Lenvatinib was granted Orphan Drug Designation in Japan for thyroid cancer, in the United States for treatment of follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer and in Europe for follicular and papillary thyroid cancer.
The development of lenvatinib underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of oncology and to address the unmet medical needs of patients and their families.
Notes to Editors
About Lenvatinib
Eisai is currently conducting clinical studies of lenvatinib in several types of cancer including hepatocellular carcinoma (Phase III), renal cell carcinoma (Phase II), non-small cell lung cancer (Phase II) and endometrial cancer (Phase II).
About Lenvatinib's Novel Binding Mode (Type V)[10],[11]
Kinase inhibitors are categorized into several types (Type I to Type V) depending on the binding site and the conformation of the targeted kinase in complex with them. Most of the currently approved tyrosine kinase inhibitors are either Type I or Type II, however according to X-ray crystal structural analysis, lenvatinib was found to possess a new Type V binding mode of kinase inhibition that is distinct from existing compounds. In addition, lenvatinib was confirmed via kinetic analysis to exhibit rapid and potent inhibition of kinase activity, and it is suggested that this may be attributed to its novel binding mode.
About SELECT[12]
The SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) study was a multicentre, randomised, double-blind, placebo-controlled Phase III study to compare the PFS of patients with DTC and radiographic evidence of disease progression within the prior 13 months, treated with once-daily, oral lenvatinib (24mg) versus placebo. The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.
Participants were stratified by age (less than or equal to65, >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 http://www.eisai.com.
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