New Data Shows Halaven® (eribulin) Mode of Action and Potential Combinations at San Antonio Breast Cancer Symposium 2015 (SABCS)

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

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/U.S. JOURNALISTS 

New data supports the previously shown ability of Halaven^® (eribulin) to reverse epithelial-to-mesenchymal transition, the process by which cancerous cells are made more aggressive and harder to treat at the San Antonio Breast Cancer Symposium 2015. The study suggests that eribulin keeps E-cadherin, a transmembrane protein, within the cancerous cell, thereby restricting further metastasis.^[1] This data is consistent with the mode of action of eribulin.^[1]

The study, "Eribulin affects E-cadherin localization consistent with a reversal of the epithelial-to-mesenchymal transition" was presented as a poster (P5-03-09) at SABCS on Friday 11 December.

"The results of this study allow us to further understand how eribulin works at a cellular level. The fact that eribulin is able to reverse the epithelial-to-mesenchymal transition is important because this leaves the cancer cells weaker and less aggressive than they would have otherwise been. This then means that subsequent chemotherapies later in the treatment cycle might prove more effective because eribulin has weakened the cancer," commented Susan Mooberry, Professor of Pharmacology, UT Health Science Center, San Antonio.

A second study presented at SABCS in stage I-II Hormone receptor positive/ Her2 negative breast cancer suggests the aggressive Luminal B form of the disease might benefit the most from treatment on eribulin.^[2] The study highlights that women with Luminal B disease treated with neoadjuvant eribulin can see their disease convert to Luminal A, again making subsequent treatments potentially more effective.^[2] Luminal B disease often has a poorer prognosis than Luminal A disease, with factors including a poorer tumour grade, a larger tumour size and lymph-node positive.^[2] Women with Luminal B are often diagnosed at a younger age than Luminal A.^[2] The study, "Efficacy and gene expression results from eribulin SOLTI1007 neoadjuvant study", was presented as a poster (P3-07-66) at the conference on Thursday 10 December. ^[2]

"The results of this study suggest that not only is eribulin an effective treatment option in a form of breast cancer with a poorer prognosis, but that the treatment may in fact convert the disease to Luminal A - a form of the disease with an improved outlook for patients. These data are very encouraging for patients and clinicians alike," commented Javier Cortés, Specialist Physician at the Oncology Department of Vall d'Hebron University Hospital.

A number of other studies at SABCS highlight the potential of eribulin to work in combination with other therapies. One study presents the design of a phase 1b/2 study to evaluate the efficacy and safety of eribulin in combination with pembrolizumab in patients with metastatic triple-negative breast cancer.^[3] The study, "Design of a phase 1b/2 study to evaluate the efficacy and safety of eribulin mesylate in combination with pembrolizumab in patients with metastatic triple-negative breast cancer", was presented as a poster (OT1-03-19) at the conference on Wednesday 9 December.^[3] A second study explores whether PH20 (PEGPH20) (Pegylated Recombinant Human Hyaluronidase) enhances efficacy of eribulin in triple negative breast cancer xenografts.^[4] The study, "Pegylated Recombinant Human Hyaluronidase PH20 (PEGPH20) Enhances Efficacy of Eribulin Mesylate (HALAVEN^®) in Triple Negative Breast Cancer Xenografts", was presented as a poster (P1-03-09) at the conference on Wednesday 9 December. Earlier this year, Eisai announced a partnership with Halozyme^™ to explore whether eribulin in combination with PEGPH20 can improve overall response rate as compared with eribulin alone, as a first line therapy for people living with advanced breast cancer.

"We are very proud that there are a total of sixteen eribulin abstracts at this year's SABCS and believe that this highlights the long-term role that eribulin has in metastatic breast cancer. It is exciting to see the additional mode of action data and also promising to see this important treatment being explored in combination with other therapies, something which should give us hope that eribulin will continue to offer benefit to patients and clinicians alike for the foreseeable future," commented Gary Hendler, President & CEO Eisai EMEA and President, Eisai Oncology Global Business Unit.

Some of the information discussed in this release is about investigational uses for eribulin. Eribulin is indicated in Europe for the treatment of adult patients 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.^[5]

Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides.

Notes to Editors  

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 which prevents cell division.^[5]

Metastatic Breast Cancer  

Over 300,000 women are diagnosed with breast cancer in Europe every year, of whom about one third subsequently develop metastatic disease.^[6],[7] Metastatic disease is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body.

HER2 is a protein that is found on the surface of cells. In HER2-positive breast cancer there is more (over expression) of this protein found on the surface of tumour cells compared with normal breast cells. This protein can be targeted with HER2 targeted therapies such as Herceptin, in people who overexpress HER2, but not in people with normal levels of HER2 protein (HER2-negative) breast cancer. Breast cancers are routinely tested for the presence of HER2 to decide the most appropriate treatment. Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express the genes for oestrogen receptor, progesterone receptor (<1%) and HER2 (<30%).

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. 

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. Dybdal-Hargreaves, N et al. Eribulin affects E-cadherin localization consistent with a reversal of the epithelial-to-mesenchymal transition. SABCS 2015. Poster session: P5-03-09

2. Prat, A et al. Efficacy and gene expression results from eribulin SOLTI1007 neoadjuvant study. SABCS 2015. Poster session: P3-07-66

3. Berrak, E et al. Design of a phase 1b/2 study to evaluate the efficacy and safety of eribulin mesylate in combination with pembrolizumab in patients with metastatic triple-negative breast cancer. SABCS 2015. Poster session: OT1-03-19

4. Bahn, J et al. Pegylated Recombinant Human Hyaluronidase PH20 (PEGPH20) Enhances Efficacy of Eribulin Mesylate (HALAVEN®) in Triple Negative Breast Cancer Xenografts. SABCS 2015. Poster session: P1-03-09

5. SmPC Halaven (updated November 2015). Available at: http://www.medicines.org.uk/emc/medicine/24382. Last accessed December 2015

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

7. Cancer Research UK. Breast cancer incidence statistics. Available at:  http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence/#world . Last accessed: December 2015

Date of preparation: December 2015        
Job code: Halaven-UK0453