Eisai

New Data for Eisai's Halaven® (eribulin) and Lenvima® (lenvatinib) in Hard to Treat Cancers will be Presented at Forthcoming American Society of Clinical Oncology (ASCO) Meeting

Hatfield, England (ots/PRNewswire) - FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS

ASCO invites six abstracts on new Halaven® (eribulin) data in liposarcoma and solid tumours, and new lenvatinib data in thyroid cancers and in renal cell carcinoma

Six abstracts that feature new study results in hard to treat cancers for Eisai's treatments eribulin and lenvatinib will be presented during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, 3-7 June 2016. These data provide new clinical evidence on the efficacy and safety of these two agents in a variety of cancers.

New lenvatinib data in thyroid cancer and renal cell cancer

New efficacy data with a focus on duration of response from the SELECT study[1] show improved duration of response to lenvatinib for patients with radioiodine-refractory differentiated thyroid cancer compared with placebo. Updated results show that 157 patients (60.2%) respond to lenvatinib and the median duration of response is 30 months (95% CI 18.4-35.2), compared with three patients (2.3%) with placebo and a median duration of response of 14.7 months (95% CI 7.5-not evaluable). Median duration of overall response is similar by subgroup, except for patients with greater disease burden and those with liver metastasis.

The final results of a single-arm open-label Phase II study[2] of lenvatinib in 51 patients with differentiated, medullary and anaplastic thyroid cancer show tumour shrinkage in almost all patients, and with manageable toxicities.

In a subgroup analysis of a Phase II study in renal cell carcinoma progression free survival benefit is maintained in high risk poor prognosis renal cancer subgroups[2] (MSKCC risk, baseline tumour size, metastasis site). Updated overall survival in the intent-to-treat population shows a trend towards improved overall survival for lenvatinib plus everolimus compared with everolimus.

New eribulin data in soft tissue sarcoma and in solid tumours

Significant benefit in overall survival is observed for eribulin compared with dacarbazine in patients with liposarcoma according to a subtype-specific analysis[3] of a Phase III study.[4] The Phase III study included patients with leiomyosarcomas or liposarcomas and results for both tumour types are published in the Lancet.[4]

In an exploratory analysis evaluating the quality of life at progression in the same Phase III study[5], there were notable increases in severity of symptoms among patients treated with dacarbazine compared with eribulin.

A phase I study shows that a liposomal formulation of eribulin is well tolerated and has promising activity in patients with solid tumours.[5]

"The results being presented at ASCO underscore Eisai's ongoing commitment to support patients with difficult to treat cancers for which there are currently too few treatment options. As part of our human health care mission we are committed to investing in innovative therapies that have the potential to improve the lives of patients and their families and deliver meaningful progress in the battle against cancer," said Kenichi Nomoto, Ph.D., Chief Scientific Officer of the Oncology Business Group, Eisai.

The full details of the six abstracts are as follows:

   

Presentation
    Product         Abstract Name                       
Details

    Lenvatinib      Phase II study of lenvatinib in 
patients  Poster
    Abstract No:    with differentiated, medullary, 
and       Presentation:
    6088            anaplastic thyroid 
cancer: final analysis Head and Neck
                    results     
Cancer
                    Takahashi S, 
et al                        Date: 4 June

Time: 1:00-4:30 PM
    Lenvatinib  
Duration of response to lenvatinib        Poster
    Abstract No: 
treatment in patients with                Presentation:
    6089   
radioiodine-refractory differentiated     Head and Neck

thyroid cancer (RR-DTC)                   Cancer

Gianoukakis A, et al                      Date: 4 June

Time: 
1:00-4:30 PM
    Lenvatinib      Subgroup analyses from the phase 2 
trial  Poster
    Abstract No:    of lenvatinib (LEN), everolimus 
(EVE),    Presentation:
    4553            and LEN+EVE in metastatic
renal cell      Genitourinary
                    carcinoma (mRCC)   
(Non-prostate)
                    Hutson T, et
al                           Cancer

Date: 6 June

Time: 1:00-4:30 PM
    Eribulin     
Phase 1 multicenter, open label study to  Poster
    Abstract No:  
establish the maximum tolerated dose      Presentation:
    2524    
(MTD) of two administration schedules of   Developmental

E7389 (eribulin) liposomal formulation in 
Therapeutics-Clini
                    patients (pts) with solid 
tumours         cal Pharmacology
                    Zubairi I, et al
and Experimental

Therapeutics

Date: 5 June

Time: 8:00-11:30 AM

Eribulin        Subtype specific activity in liposarcoma  Poster

Abstract No:   (LPS) patients (pts) from a phase 3, open  
Presentation:
    11037           label, randomised study of eribulin
(ERI) Sarcoma
                    versus dacarbazine (DTIC) in 
patients     Date: 6 June
                    with advanced LPS and 
leiomyosarcoma(LMS) Time:8:00-11:30 AM
                    Chawla S, 
et al                                             
    Eribulin      
Evaluation of quality of life at          Poster
    Abstract No:   
progression in patients with soft tissue  Presentation:
    11015    
sarcoma                                   Sarcoma

Hudgens S, et al                          Date: 6 June

Time: 8:00-11.30
AM         
 

Eribulin is indicated in Europe 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 unless patients were not suitable for these treatments.[6]

The European Commission has recently approved 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.

Lenvatinib is indicated in Europe 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]

Notes to Editors

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.

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.[6]

Lenvatinib (E7080)

Lenvatinib simultaneously inhibits VEGFR, FGFR and also RET which are especially involved in tumour angiogenesis and proliferation of thyroid cancer. [8],[9] This potentially makes lenvatinib the first TKI that simultaneously inhibits the kinase activities of FGFR 1-4 as well as VEGFR 1-3.

Lenvatinib has been approved for the treatment of refractory thyroid cancer in the United States and Japan, and has been submitted for regulatory approval in Europe, Switzerland, South Korea, Canada, Singapore, Russia, Australia and Brazil. Lenvatinib was granted Orphan Drug Designation in Japan for thyroid cancer, in the United States for treatment of follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer and in Europe for follicular and papillary thyroid cancer.

About SELECT[10],[11]

The SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) study is a multicentre, randomised, double-blind, placebo-controlled Phase III study to compare the PFS of patients with RR- radioiodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 13 months, treated with once-daily, oral lenvatinib (24mg) versus placebo. The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.

About soft tissue sarcomas

Leiomyosarcomas are one of the more common types of sarcoma to develop in adults. They develop from cells called smooth muscle and can start anywhere in the body. [12] Liposarcomas arise from fat cells and can also occur anywhere in the body. Leiomyosarcomas and liposarcomas make up approximately 30% of all cases of soft tissue sarcomas.[12]

About thyroid cancer

Thyroid cancer forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.[13] Thyroid cancer affects more than 52,000 people in Europe each year.[14]

About renal cell carcinoma

RCC accounts for approximately 90% of all kidney malignancies and represents an estimated 2-3% of all cancer cases, with the highest incidence occurring in Western countries.[15]

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. Gianoukakis A, et al. Duration of response to lenvatinib treatment in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). American Society for Clinical Oncology annual meeting 2016; Abstract # 6089

2. Hutson T, et al. Subgroup analyses from the phase 2 trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in metastatic renal cell carcinoma (mRCC). American Society for Clinical Oncology annual meeting 2016; Abstract # 4553

3. Chawla S, et al. Subtype specific activity in liposarcoma (LPS) patients (pts) from a phase 3, open label, randomised study of eribulin (ERI) versus dacarbazine (DTIC) in patients with advanced LPS and leiomyosarcoma (LMS). American Society for Clinical Oncology annual meeting 2016; Abstract # 11037

4. 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; DOI: http://dx.doi.org/10.1016/S0140-6736(15)01283-0

5. Zubairi I, et al. Phase 1 multicenter, open label study to establish the maximum tolerated dose (MTD) of two administration schedules of E7389 (eribulin) liposomal formulation in patients (pts) with solid tumours. American Society for Clinical Oncology annual meeting 2016; Abstract # 2524

6. SPC eribulin (updated March 2016). Available at: http://www.medicines.org.uk/emc/medicine/24382 . Last accessed April 2016

7. SPC lenvatinib (updated June 2015). Available at: http://www.medicines.org.uk/emc/medicine/30412 . Last accessed April 2016

8. Matsui J, et al. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumor MDA-MB-231 via inhibition of vascular endothelial growth factor receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res 2008;14:5459-65

9. Matsui J, et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008;122:664-671

10. Schlumberger M, et al. Lenvatinib versus placebo in radioiodine refractory differentiated thyroid cancer. NEJM 2015;372:621-30

11. Schlumberger M, et al. A phase 3, multicenter, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT). ASCO 2014 abstract #LBA6008

12. Cancer Research UK, Soft Tissue Sarcoma Incidence Statistics: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/soft-tissue-sarcoma/incidence/ Last accessed May 2015

13. National Cancer Institute at the National Institute of Health. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages#1 Accessed: April 2016

14. EUCAN 2015. http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=35. Accessed: April 2016

15. Ljungberg B, et al. Guidelines on Renal Cell Carcinoma. Available at: http://uroweb.org/wp-content/uploads/10-Renal-Cell-Carcinoma_LR-LV2-2015.pdf . Last accessed April 2016

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 324722 / +44 (0)7867 429 637
Alex.Davies@toniclc.com
Callum.Haire@toniclc.com
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