- For Print
- September 14, 2015
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a series of abstracts highlighting the latest clinical data on Lenvima® (generic name: lenvatinib mesylate; selective inhibitor of receptor tyrosine kinases with a novel binding mode, “lenvatinib”) and Halaven® (generic name: eribulin mesylate; halichondrin class microtubule dynamics inhibitor, “eribulin”) will be presented during the European Cancer Congress (ECC) 2015, taking place in Vienna, Austria, from September 25 to 29.
For lenvatinib, four abstract presentations are to take place at the meeting including an oral presentation highlighting an updated analysis on overall survival gain in a Phase Ⅲ clinical study on radioiodine-refractory differentiated thyroid cancer (the SELECT study), and a poster presentation on correlative analyses of serum biomarkers and clinical outcomes in a Phase Ⅱ study in patients with metastatic renal cell carcinoma, as key presentations. Lenvatinib has been approved and launched as a treatment for refractory thyroid cancer in the United States, Japan and Europe. Meanwhile, Eisai has received a Breakthrough Therapy Designation from the U.S. Federal Drugs Administration for lenvatinib regarding the indication of advanced or metastatic renal cell carcinoma.
For eribulin, a poster presentation on an analysis of quality-of-life (QOL) results from a Phase Ⅲ clinical study on soft tissue sarcoma (Study 309) will be conducted at the meeting. Currently, applications seeking approval of an additional indication for eribulin as a treatment for soft tissue sarcoma are undergoing regulatory review in Japan, the United States and Europe.
Eisai positions oncology as a key franchise area. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and in doing so seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients and their families as well as healthcare providers.
Major Eisai abstracts accepted for presentation at this year's ECC meeting include:
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| Product | Abstract title and scheduled presentation date and time (local time) |
|---|---|
Lenvatinib Abstract No: 2805 |
Overall survival gain with lenvatinib vs. placebo in radioactive iodine refractory differentiated thyroid cancer (RR-DTC): An updated analysis Oral Presentation | September 26 (Sat), 11:55-12:10 |
Lenvatinib Abstract No: 432 |
Correlative analyses of serum biomarkers and clinical outcomes in the phase Ⅱ study of lenvatinib, everolimus, and the combination, in patients with metastatic renal cell carcinoma following 1 VEGF-targeted therapy Poster Presentation | September 26 (Sat), 16:45-18:45 |
Lenvatinib Abstract No: 2862 |
The influence of time to objective response on lenvatinib clinical outcomes in the phase Ⅲ SELECT trial Poster Presentation | September 27 (Sun), 9:15-11:15 |
Lenvatinib Abstract No: 2864 |
Defining 131I-refractory differentiated thyroid cancer: efficacy and safety of lenvatinib by 131I-refractory criteria in the SELECT trial Poster Presentation | September 27 (Sun), 9:15-11:15 |
Eribulin Abstract No:3441 |
Randomized, open-label, multicenter, phase Ⅲ study of eribulin versus dacarbazine in patients with leiomyosarcoma and adipocytic sarcoma: Health-related quality of life results Poster Presentation | September 26 (Sat), 16:45-18:45 |
- (Note)SELECT : Study of E7080 “LEnvatinib” in Differentiated Cancer of the Thyroid