Halaven® (Eribulin) Demonstrates Overall Survival Benefit in Rare Soft Tissue Sarcoma Sub-types (1)

Publicado 12/10/2015 0:03:00CET

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

FOR EU MEDIA ONLY: NOT FOR SWISS OR AUSTRIAN JOURNALISTS 

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,

Switzerland 

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; p<0.001)). An updated analysis shows significantly improved overall survival in people treated with lenvatinib plus everolimus compared to everolimus alone (HR 0.51; 95% CI 0.30-0.88; P=0.024).[5]

A second abstract showed people with the papillary type of 131I-refractory differentiated thyroid cancer treated with lenvatinib had a median progression-free survival of 16.4 months compared to 3.5 months for placebo (HR:0.27; 95% CI:0.19-0.38). For people treated with lenvatinib that had the follicular type of thyroid cancer, an overall survival advantage was observed (HR:0.41; CI 0.18-0.97).[6]

"The clinical benefits observed in differentiated thyroid cancer are promising for people with these rare cancer subtypes," said Rosella Elisei, Department of Clinical and Experimental Medicine, University of Pisa.

Lenvatinib is indicated 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).[7]

"These data exemplify the strength and diversity of Eisai's oncology portfolio and our ongoing dedication to providing new potential treatments in rare cancers. In support of our human health care (hhc) mission, we remain committed to the development of compounds that have the potential to positively affect the lives of patients with cancer and their loved ones," comments Gary Hendler, President & CEO Eisai EMEA and President, Eisai Oncology Global Business Unit.

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(R) (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.

Leiomyosarcomas are one of the more common types of sarcoma to develop in adults. They start from cells in a type of muscle tissue called smooth muscle. Smooth muscles are involuntary muscles that we have no control over. They are found in the walls of muscular organs like the heart and stomach, as well as in the walls of blood vessels throughout the body. This means that leiomyosarcomas can start anywhere in the body. Common places are the walls of the womb (uterus), the trunk of the body, and the arms and legs.[8]

Liposarcomas (adipocytic sarcomas) arise from fat cells and can occur anywhere in the body. Incidence rates in males are twice as high as those in females.[9] Leiomyosarcomas and liposarcomas make up approximately 30% of all cases of soft tissue sarcomas.[10]

In Europe, approximately 29,000 people will be diagnosed with soft tissue sarcomas each year.[11] Approximately 11,930 cases of soft tissue sarcomas will be diagnosed in the United States this year.[9] In Japan, approximately 2,000 cases of soft tissue sarcomas are diagnosed each year.[12],[13]

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.[14]

Global Phase III Clinical Study 309[1]

The primary endpoint of the study was to compare overall survival between both treatment arms, and the additional endpoints included progression free survival and quality of life.

Patients were aged greater than or equal to18 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 less than or equal to2 and had received greater than or equal to2 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.

(CONTINUA)

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