Halaven® (Eribulin) Demonstrates Overall Survival Benefit in Rare Soft Tissue Sarcoma Sub-types

HATFIELD, England, October 11, 2015 /PRNewswire/ --


Five abstracts highlight the use of eribulin and lenvatinib in rare cancers at the German Association of Hematology and Oncology (DGHO) Meeting 9-13 October 2015, Basel,


Phase III data show Halaven(R) (eribulin) offers a significant overall survival benefit in people with advanced leiomyosarcoma (LMS) and adipocytic sarcoma (liposarcomas) [1] compared to dacarbazine (13.5 and 11.5 months respectively, HR=0.768, 96% CI 0.618-0.954; P=0.017).[1] Eribulin had a toxicity profile consistent with prior experience, with no unexpected or new safety findings. These data are to be presented Monday 12 October, 10:00-11:30 CEST at the DGHO in Basel, Switzerland.

"This is the first phase 3 trial to show overall survival benefit for people previously treated for soft tissue sarcomas. There is a considerable unmet need in this rare, hard-to-treat family of disease, so these results represent a very important milestone in the treatment of soft tissue sarcomas," comments Professor Patrick Schöffski, Head of the Department of General Medical Oncology, University Hospital Leuven, Belgium.

A further study presented at the DGHO showed that women with metastatic breast cancer treated with eribulin in combination with capecitabine (n=42) had an overall response rate of 42.9% (2 [4/8%] complete response and 16 [38.1%] partial response), and median progression free survival of 7.1 months (95% CI:4.4, 9.8).[2] This study confirms the safety and efficacy of the dose-combination eribulin 1.23mg/m2 and capecitabine 1000 mg/m2 twice daily. The safety and tolerability profile of the combination was consistent with previous data. These data are supported at DGHO by a case study, which shows that a person treated with 34 cycles of palliative chemotherapy with eribulin tolerated treatment well without notable side effects, and went into continuous partial remission.[3]

Based on these data, the company has submitted an application to extend the indication of Halaven(R) (eribulin) in the European Union for the treatment of patients with inoperable soft tissue sarcoma who have received prior chemotherapy for locally advanced or metastatic disease.

Eribulin is currently indicated for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.[4]

Two important abstracts at DGHO explore Lenvatinib in its recently licensed indication of differentiated thyroid cancer, and its investigational use in advanced kidney cancer.

The combination of lenvatinib plus everolimus significantly improved progression-free survival compared to everolimus alone in a phase II study of people with metastatic renal carcinoma(mRcc) following prior VEGF-targeted therapy (14.6 months versus 5.5 months respectively (HR=0.40; 95% CI,0.24-0.68; p65 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.

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 (Common Terminology Criteria for Adverse Events) 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.[18] It is more common in women than in men and most are in their 40s or 50s at time of diagnosis.[19]

Thyroid cancer affects more than 52,000 people in Europe each year.[20] 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.[21] The remaining cases are classified as either medullary (5-7% of cases) or anaplastic (1-2% of cases).[22]

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. [21] There are limited treatment options for this life-threatening and treatment-refractory form of thyroid cancer.[22]

Eisai in Oncology  

Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

About Eisai Co., Ltd. 

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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.

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1) Schöffski P, et al. Randomized, open-label, multicenter, phase 3 study of eribulin
versus dacarbazine in patients (pts) with leiomyosarcoma (LMS) and adipocytic sarcoma
(ADI). DGHO 2015; Abstract 258
2) Twelves C, et al. Efficacy and safety of eribulin in combination with capecitabine in
patients with metastatic breast cancer: an open-label phase II dose-confirmation
study. DGHO 2015; Abstract presented at DGHO 2015
3) Dobbie M, Long lasting disease stabilisation with Eribulin. DGHO 2015; Abstract
presented at DGHO 2015
4) SPC Halaven (updated June 2014). Available at:
 Accessed: September 2015
5) Motzer R, Randomized phase 2 three-arm trial of lenvatinib (LEN), everolimus (EVE),
and LEN _ EVE in patients with metastatic renal cell carcinmoa (mRCC). DGHO 2015;
Abstract presented at DGHO 2015
6) Elisei R, et al. Subgroup Analysis According to Differentiated Thyroid Cancer
Histology in Phase 3 (SELECT) Trial of Lenvatinib. DGHO 2015; Abstract presented at
DGHO 2015
7) SPC Lenvima (updated May 2015). Available at:
http://www.medicines.org.uk/emc/medicine/30412  Accessed: September 2015
8) Macmillan. What are soft tissue sarcomas? Available at:
 Accessed: September 2015
9) National Cancer Institute.
 Accessed: September 2015
10) Cancer Research UK, Soft Tissue Sarcoma Incidence Statistics:
 Accessed: September 2015
11) ESMO Guidance:
http://annonc.oxfordjournals.org/content/25/suppl_3/iii102.full.pdf+html Accessed:
July 2015
12) M. Schuichi, et al. Soft-Tissue Sarcoma Surveillance Counterpoint: Japan. Current
Clinical Oncology. 2013; 233-234
13) H. Tsujii, et al. Carbon-Ion Radiotherapy: Principles, Practices, and Treatment
Planning. Springer. 2014; (XII)312:237
14) Fletcher et al. World Health Organization Classification of Tumours of Soft Tissue and
Bone (4th Edition). Lyon: IARC Press, 2013.
15) Okamoto K, et al. Distinct Binding Mode of Multikinase Inhibitor Lenvatinib Revealed
by Biochemical Characterization. ACS Med. Chem. Lett 2015; 6:89-94
16) Wu P et al. Small-molecule kinase inhibitors: an analysis of FDA-approved drugs. Drug
Discovery Today 2015; 1-6
17) Schlumberger M, et al. Relationship Between Thyroid-Stimulating Hormone Levels and
Outcomes from the Randomized, Double-Blind, Phase 3 Study of (E7080) Lenvatinib in
Differentiated Cancer of the Thyroid (SELECT). Available at:
https://endo.confex.com/endo/2015endo/webprogram/Paper20459.html Accessed:
September 2015
18) Brito J et al. BMJ 2013; 347
19) Cabanillas ME, Dadu R. Optimizing therapy for radioactive iodine-refractory
differentiated thyroid cancer : Current state of the art and future directions.
Minerva Endocrinol. 2012 Dec; 37(4):335-356.
20) EUCAN 2015. http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=35  Accessed: June
21) Thyroid Cancer Basics. 2011. Available at: http://www.thyca.org  Accessed: June
22) Pacini F et al. ESMO Guidelines Working Group. Ann Oncol. 2012;23 (suppl 7)

Date of preparation: October 2015 



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