Eisai

European Commission Approves Halaven® (Eribulin) for Treatment of Advanced Liposarcoma in Europe

Hatfield, England (ots/PRNewswire) - FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN MEDIA

Eribulin is the first and only single agent to show a significant improvement in overall survival for people with advanced liposarcomas

People with advanced liposarcomas in Europe may now be able to receive Halaven® (eribulin), the first and only single agent therapy to show a significant survival advantage in this type of soft tissue sarcoma.[1] The European Commission has approved a variation to the terms of the Marketing Authorisation (MA) 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.

The decision is based on the results of Study 309 which is now published in The Lancet. This is a randomised, open-label multicentre Phase III study comparing the efficacy and safety of eribulin mesilate to dacarbazine in 452 patients (aged 18 or over) with leiomyosarcomas or liposarcomas.[1] Data show a median overall survival improvement of 2.6 months (13.5 months versus 11.5 months) in patients with leiomyosarcomas or liposarcomas treated with eribulin versus dacarbazine (HR=0.768, 95% CI 0.618-0.954; P=0.017).[1] A subset of people with unresectable advanced or metastatic liposarcomas treated with eribulin lived a median 7.2 months longer than those treated with dacarbazine (15.6 months versus 8.4 months median OS, HR = 0.511; 95% CI 0.346-0.753; P=0.0006).[1] Eribulin's toxicity profile was consistent with prior experience, with no unexpected or new safety findings.[1]

"This decision marks an important milestone for people in Europe with advanced liposarcomas. There are currently limited treatment options available, but now, we are a step closer to being able to offer them a treatment with a proven overall survival benefit. Eribulin was the first-ever single agent therapy to show such a survival benefit, which makes today's news all the more important for patients and clinicians across Europe," comments Patrick Schöffski, University Hospitals Leuven, Belgium.

Eribulin is a microtubule-dynamics inhibitor, structurally modified analogue of halichondrin B, originally isolated from the marine sponge Halichondria okadai. Its mode of action is distinct from other tubulin inhibitors and involves binding to specific sites on the growing positive ends of microtubules to inhibit their growth. Recent data for blood perfusion show that eribulin may lead to remodelling of the tumour vasculature, resulting in an oxygenated environment.[2] Cancer cells thrive in a deoxygenated (hypoxic) environment and therefore improving tumour perfusion may lead to a decrease in tumour metastatic potency.[3]

Only 50% of people with soft tissue sarcomas are expected to live for five years.[4] 29,000 people are diagnosed with soft tissue sarcomas each year, approximately 1% of all cancers diagnosed in Europe.[5] Liposarcomas (adipocytic sarcomas) originate in fat cells and can occur anywhere in the body.[6]

Eribulin is also 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.[7]

"At Eisai, our first thought is with people in Europe who now have access to this new treatment and the benefit it may have for them and their families. This is the second form of cancer in which eribulin has demonstrated an overall survival benefit when compared to active therapy. We are encouraged by the Commission's decision, and will continue with our commitment to develop and discover products that have a positive impact on patients and their families," comments Gary Hendler, Chief Commercial Officer Oncology Business Group, Chairman and CEO EMEA.

In January 2016 the Food and Drug Administration (FDA) approved eribulin for the treatment of people in the US with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. License was granted in Japan to extend the indication of eribulin to treat patients with soft tissue sarcomas in February 2016.

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.

About Soft Tissue Sarcomas

Soft tissue sarcoma is a collective term for a diverse group of malignant tumours.

Unlike other cancers such as non-small cell lung cancer (NSCLC), soft tissue sarcomas are mostly diagnosed with localised disease, and many are amenable to complete surgical removal, yet relapse rates can be as high as 50 percent.[8] Outcomes for patients with advanced disease are poor, with median survival around one year or less. Due to the rarity of these tumours, evidence for prognostic factors is weak and not well understood.[9]

Global Phase III Clinical Study 309[1]

The primary endpoint of the study was to compare overall survival between patients treated with eribulin mesilate (1.4 mg/m² intravenously on days 1 and 8) and those treated with dacarbazine (850 mg/m², 1000 mg/m², or 1200 mg/m² [dose dependent on centre and clinician] intravenously on day 1). The additional endpoints included progression free survival and quality of life.

Patients were aged >=18 years with advanced high/intermediate grade leiomyosarcoma or dedifferentiated, myxoid, round cell or pleomorphic variants of adipocytic sarcoma (ADI) incurable by surgery and/or radiotherapy were enrolled. Patients had ECOG status <=2 and had received >=2 standard systemic treatment regimens including an anthracycline. Patients were randomized 1:1 to eribulin mesilate (1.4 mg/m2, IV on D1 and D8) or dacarbazine (850-1200 mg/m2, IV on D1) every 21 days until disease progression.

Overall, 452 patients (67% female; 79% <65 years) were randomized (228 eribulin; 224 dacarbazine). Median OS for eribulin and dacarbazine was 13.5 and 11.5 months, respectively (HR=0.768, 95% CI 0.618-0.954; P=0.017). PFS was 2.6 months in both arms (HR=0.877, 95% CI 0.710-1.085; P=0.229). PFS rate at week 12 was 33% and 29% for eribulin and dacarbazine, respectively. Eribulin had a toxicity profile consistent with prior experience, with no unexpected or new safety findings. In this study, the most common adverse events observed in the eribulin arm were neutropenia, fatigue, nausea, alopecia and constipation, which is consistent with the known profile of eribulin.

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. Schöffski P et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016

2. Kawano S, et al. Antimitotic and Non-mitotic Effects of Eribulin Mesilate in Soft Tissue Sarcoma. Anticancer Research 2016; 36; 1553-1562

3. Kevin L Bennewith and Shoukat Dedhar. Targeting hypoxic tumour cells to overcome metastasis. BMC Cancer 2011;11:504

4. National Cancer Institute - http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-survival-rates

5. ESMO Guidance. Available at: http://annonc.oxfordjournals.org/content/25/suppl_3/iii102.full.pdf+html Accessed: May 2016

6. Macmillan. What are soft tissue sarcomas? Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Softtissuesarcomas/Aboutsofttissuesarcomas/Softtissuesarcomas.aspx . Accessed: May 2016

7. SPC Halaven (updated November 2015). Available at: http://www.medicines.org.uk/emc/medicine/24382 Accessed: May 2016

8. R Pollock. Soft Tissue Sarcomas, A Volume in the American Cancer Society Atlas of Clinical Oncology Series. 2012

9. Fletcher, et al. World Health Organization Classification of Tumours of Soft Tissue and Bone (4th Edition). Lyon: IARC Press, 2013

Contact:

Eisai
Cressida Robson / Ben Speller
+44(0)7908 314 155/+44(0) 7908 409416
Cressida_Robson@eisai.net
Ben_Speller@eisai.net
Tonic Life Communications
Alex Davies / Callum Haire
+44 (0)7716 324 722 / +44 (0)7867 429 637
Alex.Davies@toniclc.com
Callum.Haire@toniclc.com

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