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EISAI TO PRESENT NEW RESEARCH ON ONCOLOGY PRODUCTS AND PIPELINE AT 50TH ASCO ANNUAL MEETINGHIGHLIGHTS INCLUDE NEW PHASE Ⅲ CLINICAL DATA ON INVESTIGATIONAL ANTICANCER AGENT LENVATINIB IN RADIOIODINE-REFRACTORY DIFFERENTIATED THYROID CANCER

°®¶¹´«Ã½. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) announced today that a series of abstracts highlighting new study results on Halaven® (generic name: eribulin mesylate; non-taxane microtubule dynamics inhibitor, “eribulin”) and lenvatinib (generic name; selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode) will be presented during the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, the United States, from May 30 to June 3, 2014.

The main presentations for this year's ASCO meeting include oral presentations highlighting the results of a Phase Ⅲ study (the SELECT (Study of E7080 LEnvatinib in differentiated Cancer of the Thyroid) study, Study 303) with lenvatinib, an investigational agent being evaluated as a potential treatment for radioiodine-refractory differentiated thyroid cancer (RR-DTC), to be given on Monday, June 2. In addition, these findings have been chosen by ASCO to be featured in a press conference as part of the ASCO Annual Meeting press program starting at 8:00 a.m. CDT on Saturday, May 31 (Venue: E353a, McCormick Place). New data on eribulin from the pooled analysis of two Phase Ⅲ trials (Study 301 and the EMBRACE trial) in patients with metastatic breast cancer is also to be presented at the meeting.

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 ASCO meeting include:

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Product Abstract title and scheduled presentation date and time (local time)

Lenvatinib
(E7080)

Abstract No:LBA6008

A phase Ⅲ, multicenter, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT).

Oral Presentation | June 2 (Mon), 10:28-10:40 (E450, McCormick Place)

Lenvatinib
(E7080)

Abstract No: 11061

Prognostic and predictive role of circulating angiopoietin-2 in multiple solid tumors: An analysis of approximately 500 patients treated with lenvatinib across tumor types.

Poster Presentation | May 31 (Sat), 13:15-17:00

Lenvatinib
(E7080)

Abstract No: TPS4153

A multicenter, open-label, phase Ⅲ trial to compare the efficacy and safety of lenvatinib (E7080) versus sorafenib in first-line treatment of subjects with unresectable hepatocellular
carcinoma.
Poster Presentation | May 31 (Sat), 8:00-11:45

Lenvatinib
(E7080)

Abstract No: 8043

E7080 (lenvatinib) in addition to best supportive care (BSC) versus BSC alone in third-line or greater nonsquamous, non-small cell lung cancer (NSCLC).

Poster Presentation | June 1 (Sat), 13:15-17:00

Eribulin
(Halaven®)

Abstract No: 631

Efficacy of eribulin in patients (pts) with metastatic breast cancer (MBC): A pooled analysis by HER2 and ER status.

Poster Presentation | June 2 (Mon), 08:00-11:45

Eribulin
(Halaven®)

Abstract No: 629

Clinical effects of prior anthracycline or taxane use on eribulin as first-line treatment for HER+/- locally recurrent or metastatic breast cancer (BC): Results from two phase Ⅱ, multicenter,
single-arm studies.
Poster Presentation | June 2 (Mon), 08:00-11:45

Eribulin
(Halaven®)

Abstract No: 635

Clinical effects of prior trastuzumab on combination eribulin mesylate plus trastuzumab as first-line treatment for HER2+ locally recurrent or metastatic breast cancer (MBC): Results from
a phase Ⅱ, single-arm, multicenter study.
Poster Presentation | June 2 (Mon), 08:00-11:45

Eribulin
(Halaven®)

Abstract No: TPS670

Phase Ⅱ feasibility study of dose-dense doxorubicin and cyclophosphamide (AC) followed by eribulin mesylate with or without prophylactic growth factor (GF) for adjuvant treatment of
early-stage breast cancer (EBC).
Poster Presentation | June 2 (Mon), 08:00-11:45

Eribulin
(Halaven®)

Abstract No: 10567

Phase Ⅱ study of eribulin mesylate in patients (pts) with advanced soft tissue sarcoma (STS).


Poster Presentation | June 2 (Mon), 08:00-11:45

Eribulin
(Halaven®)

Abstract No: 2595

Pharmacokinetics (PK) of eribulin mesylate in cancer patients (pts) with normal and impaired renal function.

Poster Presentation | June 1 (Sun), 08:00-11:45

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