New Data for Halaven® (eribulin) at SABCS 2016 Demonstrate Continued Potential in Treatment of Multiple Types of Locally Advanced or Metastatic Breast Cancer

HATFIELD, England, November 29, 2016 /PRNewswire/ --

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/US JOURNALISTS  

Eisai highlights 17 new data abstracts for eribulin in metastatic breast cancer at the San Antonio Breast Cancer Symposium (SABCS), San Antonio, USA, 6-10 December.

Eribulin is indicated in the European Union for the treatment of adults 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 unless patients were not suitable for these treatments.^[1]

"Eribulin has previously demonstrated a clinically meaningful overall survival benefit in two pivotal studies in advanced breast cancer and advanced sarcoma. Eisai remains fully committed to continue developing eribulin and we look forward to the presentation of these results at the SABCS," comments Gary Hendler Chief Commercial Officer, Global Oncology Business Group and Chairman & CEO EMEA.

The continued development of its oncology portfolio underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of oncology and to address the unmet medical needs of people with cancer and their families.

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Abstract Name 

A phase II, open-label, multicentre, translational study for biomarkers of eribulin mesylate: evaluation of the utility of monitoring epithelial-to-mesenchymal transition (emt) markers on tumour cells in the malignant plural effusion of patients with metastatic breast cancer (expect-study)

Watanabe et al 

Poster: OT1-01-01

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

PAINTER: Evaluation of eribulin tolerability and correlation between a set of polymorphisms and neuropathy in patients with metastatic breast cancer

La Verde et al 

Poster: OT1-01-05

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

PIQHASSO: Open label, non-randomised, multicentre phase I/IIb study investigating safety and efficacy of PQR309 and eribulin combination in patients (pts) with locally advanced (LA) or metastatic HER2 (-) and triple-negative breast cancer (TNBC) (study PQR309-007)

López et al 

Poster: OT1-01-06

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

A phase II study of eribulin followed by doxorubicin and cyclophosphamide as preoperative therapy for HER2-negative inflammatory breast cancer

Overmoyer et al  

Poster: OT1-01-07

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

A phase II, multicentre, randomised trial of eribulin plus gemcitabine (EG) vs. paclitaxel plus gemcitabine (PG) in patients with HER2-negative metastatic breast cancer as first-line chemotherapy

Park et al  

Poster: OT1-01-12

Session Title: Ongoing Trials - Chemotherapy

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

Efficacy and gene expression results from SOLTI1007 NEOERIBULIN phase II clinical trial in HER2-negative early breast cancer

Prat et al  

Poster: P1-09-09

Session Title: Prognostic and Predictive Factors: Response Predictive Factors - Clinical Testing and Validation

Session Date: 7/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

A randomized, open-label, multicentre, phase Ib/II study of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase in patients with human epidermal growth factor receptor 2-negative, high-hyaluronan metastatic breast cancer

Alvarez et al 

Poster: OT2-02-02

Session Title: New Approaches and Agents

Session Date: 8/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

Eribulin induces vascular remodelling and reoxygenation in advanced breast cancer patients: A comparative study with bevacizumab

Ueda et al  

Poster: P4-02-01

Session Title: Detection/Diagnosis: Breast Imaging - Other Methods

Session Date: 9/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

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Abstract Name 

Eribulin impairs TGFβ type I receptor localization and signaling in BT549 cells

Kaul et al  

Poster: P4-04-04

Session Title: Tumour Cell and Molecular Biology: Epithelial-Mesenchymal Transition

Session Date: 9/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

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Abstract Name 

Phase Ib/II study to evaluate eribulin mesylate in combination with pembrolizumab in patients with metastatic triple-negative breast cancer

Tolaney et al  

Poster: P5-15-02

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

A phase II study of eribulin as early-line treatment for HER2- MBC: Evaluation of efficacy, toxicity, and patient-reported outcomes

Metzger et al  

Poster: P5-15-08

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

Eribulin mesylate (eribulin) showed inhibitory effects on epithelial-mesenchymal transition (EMT) in tumours of metastatic breast cancer patients. First preliminary report of a prospective study

Utsumi et al 

Poster: P5-15-10

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

Eribulin should be a candidate strategy in combination with pertuzumab plus trastuzumab for taxane pretreated HER2 positive advance breast cancer

Araki et al  

Poster: P5-15-11

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

Utilization and outcomes of eribulin in triple negative metastatic breast cancer: real-world findings

Kish et al  

Poster: P5-15-16

Session Title: Treatment: Advanced Chemotherapy

Session Date: 9/12/16

Session Time: 17.00 - 19.00

Location: Hall 1

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Abstract Name 

High reduction of circulating tumour cells in HER2-negative locally advanced or metastatic breast cancer (LAMBC) patients treated with eribulin as third line chemotherapy (ONSITE study)

Manso et al  

Poster: P6-07-21

Session Title: Tumour Cell and Molecular Biology: Biomarkers

Session Date: 10/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

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Abstract Name 

CASCADE study: Rapid survival decline per treatment line in metastatic breast cancer

García et al 

Poster: P6-09-33

Session Title: Prognostic and Predictive Factors: Prognostic and Predictive Factors - Other

Session Date: 10/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

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Abstract Name 

Efficacy results of a phase 1/2 study of glucocorticoid receptor (GR) antagonist mifepristone (MIFE) in combination with eribulin in GR-positive triple-negative breast cancer (TNBC)

Han et al  

Poster: P6-12-15

Session Title: Treatment: New Drugs and Treatment Strategies

Session Date: 10/12/16

Session Time: 7.30 - 9.00

Location: Hall 1

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Notes to Editors   

About Metastatic Breast Cancer   

More than 300,000 women are diagnosed with breast cancer in Europe every year and about one third subsequently develop metastatic disease.^[2] At this advanced stage, the cancer spreads beyond the breast to other parts of the body.

About Halaven^® (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 that prevents cell division.

The European Commission approved in May 2016 a variation to the terms of the Marketing Authorisation of eribulin for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Eisai in Oncology   

Eisai is committed to the development and delivery of highly beneficial new treatments for people with cancer. The development of therapeutic options in oncology is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA). In the European Union, Eisai currently has three marketed treatments across four indications:

• Lenvima^® (lenvatinib) is indicated in the European Union for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).
• Kisplyx^® (lenvatinib) is indicated in the European Union in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
• Halaven^® (eribulin) is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have received 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. Halaven^® (eribulin) is also indicated for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

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.     EMA, Halaven. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002084/smops/Positive/human_smop_000955.jsp&mid=WC0b01ac058001d127. Accessed November 2016

2.     World Health Organisation. Atlas of Health in Europe. 2003. World Health Organization, Regional Office of Europe, Copenhagen, Denmark.

November 2016
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