New Data for Eisai's Halaven® (eribulin) and Lenvima® (lenvatinib) in Hard to Treat Cancers will be Presente

Halaven(R) (eribulin)  

Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.[6]

Lenvatinib (E7080) 

Lenvatinib simultaneously inhibits VEGFR, FGFR and also RET which are especially involved in tumour angiogenesis and proliferation of thyroid cancer. [8],[9] This potentially makes lenvatinib the first TKI that simultaneously inhibits the kinase activities of FGFR 1-4 as well as VEGFR 1-3.

Lenvatinib has been approved for the treatment of refractory thyroid cancer in the United States and Japan, and has been submitted for regulatory approval in Europe, Switzerland, South Korea, 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.

About SELECT[10],[11]

The SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) study is a multicentre, randomised, double-blind, placebo-controlled Phase III study to compare the PFS of patients with RR- radioiodine-refractory differentiated thyroid cancer 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.

About soft tissue sarcomas

Leiomyosarcomas are one of the more common types of sarcoma to develop in adults. They develop from cells called smooth muscle and can start anywhere in the body. [12] Liposarcomas arise from fat cells and can also occur anywhere in the body. Leiomyosarcomas and liposarcomas make up approximately 30% of all cases of soft tissue sarcomas.[12]

About thyroid cancer

Thyroid cancer forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.[13] Thyroid cancer affects more than 52,000 people in Europe each year.[14]

About renal cell carcinoma

RCC accounts for approximately 90% of all kidney malignancies and represents an estimated 2-3% of all cancer cases, with the highest incidence occurring in Western countries.[15]

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.     Gianoukakis A, et al.  Duration of response to lenvatinib treatment in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC).  American Society for Clinical Oncology annual meeting 2016; Abstract # 6089

2.     Hutson T, et al. Subgroup analyses from the phase 2 trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in metastatic renal cell carcinoma (mRCC).  American Society for Clinical Oncology annual meeting 2016; Abstract # 4553

3.     Chawla S, et al.  Subtype specific activity in liposarcoma (LPS) patients (pts) from a phase 3, open label, randomised study of eribulin (ERI) versus dacarbazine (DTIC) in patients with advanced LPS and leiomyosarcoma (LMS).  American Society for Clinical Oncology annual meeting 2016; Abstract # 11037

4.     Schöffski P, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016; DOI: http://dx.doi.org/10.1016/S0140-6736(15)01283-0

5.     Zubairi I, et al.  Phase 1 multicenter, open label study to establish the maximum tolerated dose (MTD) of two administration schedules of E7389 (eribulin) liposomal formulation in patients (pts) with solid tumours. American Society for Clinical Oncology annual meeting 2016; Abstract # 2524

6.     SPC eribulin (updated March 2016). Available at: http://www.medicines.org.uk/emc/medicine/24382 . Last accessed April 2016

7.     SPC lenvatinib (updated June 2015). Available at: http://www.medicines.org.uk/emc/medicine/30412 . Last accessed April 2016

8.     Matsui J, et al. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumor MDA-MB-231 via inhibition of vascular endothelial growth factor receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res 2008;14:5459-65

9.     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;122:664-671

10.     Schlumberger M, et al. Lenvatinib versus placebo in radioiodine refractory differentiated thyroid cancer. NEJM 2015;372:621-30

11.     Schlumberger M, et al.  A phase 3, multicenter, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT).  ASCO 2014 abstract #LBA6008

12.     Cancer Research UK, Soft Tissue Sarcoma Incidence Statistics: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/soft-tissue-sarcoma/incidence Last accessed May 2015

13.     National Cancer Institute at the National Institute of Health. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages#1  Accessed: April 2016

14.     EUCAN 2015. http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=35. Accessed: April 2016

15.     Ljungberg B, et al. Guidelines on Renal Cell Carcinoma. Available at: http://uroweb.org/wp-content/uploads/10-Renal-Cell-Carcinoma_LR-LV2-2015.pdf . Last accessed April 2016

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