Two recent subanalyses from the SELECT study have been presented at the Endocrine Society Congress 2015 (ENDO). The first reports the results of the open-label extension phase of SELECT and aims to assess the crossover of patients in the placebo arm to the optional open-label lenvatinib treatment period. The results highlight that patients who crossed over from the placebo arm achieved a median PFS of 12.4 months with open-label lenvatinib treatment. Although toxicities were substantial, these were generally managed with medications, dose interruption, and dose reductions.
The second abstract examines the relationship between thyroid abnormalities and their effect on the safety and efficacy outcomes in SELECT. The analysis shows that although an increase in thyroid-stimulating hormone (TSH) levels was a frequent complication, its direct relationship to lenvatinib therapy has not been established and there is no evidence TSH levels affect tumour responses to lenvatinib treatment.
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.[14] It is more common in women than in men and most are in their 40s or 50s at time of diagnosis.[15]
Thyroid cancer affects more than 52,000 people in Europe each year.[7] The incidence of thyroid cancer has increased significantly in the last decade by 69% and 65% in men and women, respectively.[16] The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 85-90% of all cases.[17],[18],[19] The remaining cases are classified as either medullary (3-4% of cases)[20] or anaplastic (1-2% of cases).[15],[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.
References
1. European Commission Decision. Data on file. 2015
2. SPC Lenvima (august 2015) http://www.swissmedicinfo.ch
3. European Medicines Agency, EMAR - Lenvima http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human /003727/WC500188676.pdf Accessed: October 2015
4. Schlumberger M et al. Lenvatinib versus placebo in radioiodine refractory differentiated thyroid cancer. NEJM 2015; 372: 621-630. Available at http://www.nejm.org/doi/full/10.1056/NEJMoa1406470 Accessed: October 2015
5. Matsui J, et al. Multi-Kinase Inhibitor E7080 Suppresses Lymph Node and Lung Clin Cancer Res 2008;14:5459-65
6. Matsui J, et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008;122:664-71
7. Okamoto K, et al. Distinct Binding Mode of Multikinase Inhibitor Lenvatinib Revealed by Biochemical Characterization. ACS Med. Chem. Lett 2015;6:89-94
8. Wu P. Small-molecule kinase inhibitors: an analysis of FDA-approved drugs. Drug Discovery Today, July 2015; 1-6
9. EUCAN 2015. http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=35. Accessed: October 2015
10. Kilfoy BA et al. Cancer Causes Control. 2009 Jul;20(5):525-31
11. EUCAN, Thyroid Cancer Estimated incidence, mortality & prevalence for both sexes, 2012, Available at: http://eco.iarc.fr/eucan/Cancer.aspx?Cancer=35 Accessed: October 2015
12. Butterfly Thyroid Cancer Trust. About Thyroid Cancer. Available at : http://www.butterfly.org.uk/about.htm Accessed: October 2015
13. Newbold K et al. Phase 3 study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT): Results and subgroup analysis of patients from Europe. Presented as a digital poster at ETA 2014.
14. National Cancer Institute at the National Institute of Health. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages#1 . Accessed: October 2015
15. Brito J et al. BMJ 2013; 347
16. Cancer Research UK. Thyroid cancer incidence statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/thyroid/incidence/uk-thyroid -cancer-incidence-statistics. Accessed: October 2015
17. Pacini F et al. ESMO Guidelines Working Group. Ann Oncol. 2012;23(suppl 7) :vii110-vii119
18. Thyroid Cancer Basics. 2011, 2012, at: http://www.thyca.org. Accessed: October 2015
19. Cooper DS et al; Thyroid. 2009;19:1167-1214
20. National Cancer Institute. Medullary Thyroid Cancer. http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/HealthProfessional/page7. Accessed: October 2015
CONTACT: Media Enquiries: Eisai: Cressida Robson / Ben Speller, 2 Nov. (0) - 7908314 155 / +44(0) 7908 409416, Cressida_Robson@eisai.net,Ben_Speller@eisai.net Tonic Life Communications: Alex Davies / EmmaCoughlan, + 44 (0)7720 496 472 / +44 (0)7772 534 646,Alex.Davies@toniclc.com, Emma.Coughlan@toniclc.com
