New Data for Halaven® (eribulin), Lenvima® (lenvatinib) and Kisplyx® (lenvatinib) Demonstrate Continued Strength of Eisai Oncology Portfolio at ESMO 2016

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





FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN JOURNALISTS  

Eisai highlights seven new data abstracts in hard to treat cancers for eribulin and lenvatinib at the European Society for Medical Oncology (ESMO) Congress, Copenhagen, 7-11 October 2016.

Lenvatinib data in thyroid cancer, renal cell carcinoma and other solid tumours  

An investigational phase II study for lenvatinib focuses on the treatment of KIF5B-RET-positive adenocarcinoma of the lung.[1] Adenocarcinoma is a type of non-small cell lung carcinoma, one of the most common forms of lung cancer.[1] RET fusions activate RET kinase and occur in 1-2% of patients.[1]

Exploratory early phase data will review lenvatinib with anti PD-1 therapy including a phase Ib study in people with selected solid tumours.[2]

Subanalyses from the pivotal SELECT study investigate responses in specific metastasis sites following treatment with lenvatinib for patients with radioiodine-refractory (RAI-R) differentiated thyroid cancer (DTC).[3] SELECT is a multicentre randomised, double-blind, placebo-controlled phase III study to compare the progression-free survival (PFS) of patients with radioiodine-refractory differentiated thyroid cancer.[4]

A pre-clinical study examines the VEGFR and FGFR signalling pathway participation in tumour growth and angiogenesis in human renal cell carcinoma xenografts treated with the combination of lenvatinib plus everolimus.[5] A further pre-clinical study analyses immune response in syngeneic murine tumour models to understand the antitumour effect and mechanism of action of the combination of lenvatinib and PD-1 blockade treatment in a number of cancer models.[6]

Epidemiological data in metastatic breast cancer   

A study investigates the progressive decline in efficacy of active agents in locally advanced or metastatic breast cancer with each successive therapy cycle.[7] The study includes data from 443 patients in Spain with locally advanced or metastatic breast cancer.[7]

Eribulin data in metastatic breast cancer  

A study investigates the safety of eribulin in third-line chemotherapy in 59 patients with HER2-negative metastatic or locally advanced breast cancer.[8]  

Exploratory data from the investigational, phase II, multicentre, single arm trial (MERIBEL) will examine the efficacy and safety of eribulin as a first-line therapy for HER2-metastatic breast cancer.[9]

Eribulin data in soft tissue sarcomas  

Results will be presented from a pre-specified subgroup analysis in leiomyosarcomas of the phase III 309 study comparing eribulin to dacarbazine.[10] Eribulin is not licensed in leiomyosarcomas in the European Union.

"Eisai is committed to the development of innovative treatments for people with cancer and always gives first thought to patients and their families. Eribulin has demonstrated a unique overall survival benefit compared to active comparators in advanced or metastatic breast cancer and unresectable liposarcoma. Lenvatinib delivers rapid, pronounced and durable responses and significantly prolongs the time before a cancer progresses in both advanced thyroid and advanced kidney cancer," comments Gary Hendler, Chairman & CEO EMEA and Chief Commercial Officer, Global Oncology Business Group, Eisai.


 
Eisai Oncology Data at ESMO 2016 

 
Lenvatinib 

 
Poster: 1204PD

 
Abstract Name: Phase II study of lenvatinib in patients with RET fusion-positive
adenocarcinoma of the lung (Velcheti V et al)

 
Poster Discussion: NSCLC, metastatic 
Date: 09 Oct 16 
Time: 14:45-16:15 
Room: Oslo

 
Poster: 776PD

 
Abstract Name: A phase Ib trial of lenvatinib plus pembrolizumab in patients with
selected solid tumours (Taylor M et al)

 
Poster Discussion: Genitourinary tumours, non-prostate 
Date: 09 Oct 16 
Time: 16:30-17:30 
Room: Athens

 
 
Poster: 2PD

 
Abstract Name: Lenvatinib mesilate enhanced antitumour activity of PD-1 blockade agent
by potentiating Th1 immune response(Kato Y et al)

 
Poster Discussion: Basic science and translational research 
Date: 09 Oct 16 
Time: 16:30-17:30 
Room: Berlin

 
 
Poster: 962P

 
Abstract Name: Responses in specific metastases following treatment with lenvatinib:
results from the phase III SELECT study (Robinson B et al)

 
Poster Presentation: Poster display 
Date: 09 Oct 16 
Time: 13:00-14:00 
Room: Hall E

 
 
Poster: 6P

 
Abstract Name: The antitumour activity of lenvatinib in combination with everolimus in
human RCC xenograft models is dependent on VEGFR and FGFR signalling (Kimura T et al)

 
Presentation Details

 
Poster Presentation: Poster display 
Date: 10 Oct 16 
Time: 13:00-14:00 
Room: Hall E

 
Epidemiological Data 

 
Poster: 248P

 
Abstract Name: CASCADE study: pronounced decline in treatment efficacy through the
metastatic life of breast cancer patients (De Paz L et al)

 
Poster Presentation: Poster display 
Date: 10 Oct 16 
Time: 13:00-14:00 
Room: Hall E

 
Eribulin 

 
Poster: 238P

 
Abstract Name: MERIBEL study: First-line eribulin for taxane-resistant HER2[-]
metastatic breast cancer (MBC) patients (Ortega V et al)

 
Poster Presentation: Poster display 
Date: 10 Oct 16 
Time: 13:00-14:00 
Room: Hall E

 
Poster: 246P

 
Abstract Name: Single arm, multicentre, non-randomized open-label trial to evaluate the
safety of eribulin in third line chemotherapy in patients with HER2-negative
metastatic or locally advanced breast cancer previously treated with anthracyclines
and taxanes: Onsite study (ONCOSUR 2012-02)(Manso L et al)

 
Poster Presentation: Poster display 
Date: 10 Oct 16 
Time: 13:00-14:00 
Room: Hall E

 
 
Poster: 1401PD

 
Abstract Name: Subgroup analysis in leiomyosarcoma (LMS) patients from a phase III,
open-label, randomised study of eribulin versus dacarbazine in patients with advanced
liposarcoma (LPS) and LMS (Blay J et al)

 
Poster Discussion: Sarcoma 
Date: 10 Oct 16 
Time: 11:00-12:00 
Room: Brussels

 
 



 

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.

Notes to Editors   

About Thyroid Cancer  

Thyroid cancer forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.[11]Thyroid cancer affects more than 52,000 people in Europe each year.[12]

About Renal Cell Carcinoma (RCC)  

Kidney cancer is among the ten most frequently occurring cancers in Western (countries) communities.[13] About 270,000 cases of kidney cancer are diagnosed globally each year and 116,000 people die from the disease.[13]Approximately 90% of all kidney cancers are renal cell carcinomas (RCC).[13]

About Lenvatinib   

Lenvatinib is an oral multikinase inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor-alpha, and RET and KIT proto-oncogenes.[14],[15]

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).[16]  Lenvatinib is approved for the treatment of refractory thyroid cancer in the United States, Switzerland, the European Union, Canada, Russia, Australia, South Korea, Israel, Singapore, Japan and Brazil.

In September 2016, the European Commission issued Marketing Authorisation for lenvatinib 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.

About SELECT[4]

SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) is a multicentre, randomised, double-blind, placebo-controlled phase III study of patients with radioiodine-refractory differentiated thyroid cancer, treated with once-daily, oral lenvatinib (24mg). The study enrolled 392 patients in over 100 sites in Europe, Americas, Asia, and Australia.

About Study 205[17] 

Study 205 is a pivotal randomised phase II study that evaluated 153 people living with unresectable advanced renal cell carcinoma who had progressed after one previous VEGF therapy.[17] Patients experienced a median progression-free survival of 14.6 months when treated with lenvatinib in combination with everolimus (n=51), compared with 5.5 months for those who received everolimus alone (n=50) (HR 0.40; 95% CI: 0.24-0.67; p=0.0005).[17]  Updated median overall survival in the study population was 25.5 months in the lenvatinib plus everolimus group compared with 15.4 months in the everolimus group (HR 0.59; 95% CI 0.36 - 0.97).[17]

For lenvatinib in combination with everolimus, the most common any-grade treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhoea, decreased appetite and fatigue.[17] The most common TEAEs of Grade 3 or higher were diarrhoea, fatigue and hypertension.[17]

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.[18] At this advanced stage, the cancer spreads beyond the breast to other parts of the body.

About Soft Tissue Sarcomas  

Soft tissue sarcomas is a collective term for a diverse group of malignant tumours. Unlike other cancers, soft tissue sarcomas are often diagnosed with localised disease, and many are amenable to complete surgical removal, yet relapse rates can be as high as 50%. [19] Only 50% of people with soft tissue sarcomas are expected to live up to five years. [20] Outcomes for patients with advanced disease are poor, with median survival around one year or less.[21]

Leiomyosarcomas are one of the more common types of sarcoma to develop in adults. They develop from smooth muscle cells and can start anywhere in the body.[22] Liposarcomas arise from fat cells and can occur anywhere in the body. Leiomyosarcomas and liposarcomas make up approximately 30% of all cases of soft tissue sarcomas.[21]

About 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 that prevents cell division.

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 in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.[23]

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.

Global Phase III Clinical Study 309[24] 

Study 309 is a randomised, open-label, multicentre phase III study comparing the efficacy and safety of eribulin mesilate (1.4 mg/m[2], IV on days 1 and 8) to dacarbazine (850-1200 mg/m[2], IV on day 1) in a 21-day cycle. A total of 452 patients (aged 18 or over) with soft tissue sarcomas were randomised. The primary endpoint of the study was overall survival. Additional endpoints included progression-free survival and quality of life.

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. Velcheti V, et al. Phase 2 study of lenvatinib (LN) in patients (Pts) with RET fusion-positive adenocarcinoma of the lung. European Society for Medical Oncology 2016; Poster: 1204PD

2. Taylor M, et al. A phase 1b trial of lenvatinib (LEN) plus pembrolizumab (PEM) in patients with selected solid tumours. European Society for Medical Oncology 2016; Poster: 776PD

3. Robinson B, et al. Responses in specific metastases following treatment with lenvatinib (LN): results from the phase 3 SELECT trial. European Society for Medical Oncology 2016; Poster: 962P

4. Schlumberger M, et al. Lenvatinib versus placebo in radioiodine-refractory differentiated thyroid cancer. NEJM 2015; 372: 621-630. Available at http://www.nejm.org/doi/full/10.1056/NEJMoa1406470  Accessed: September 2016

5. Kimura T, et al. The antitumor activity of lenvatinib (LEN) in combination with everolimus (EVE) in human renal cell carcinoma (RCC) xenograft models is dependent on VEGFR and FGFR signalling. European Society for Medical Oncology 2016; Poster: 6P

6. Kato Y, et al. Lenvatinib mesilate (LEN) enhanced antitumor activity of a pd-1 blockade agent by potentiating th1 immune response, European Society for Medical Oncology (ESMO) meeting 2016, Poster: 2PD

7. De Paz L, et al. CASCADE study: Pronounced decline in treatment efficacy through the metastatic life of breast cancer patients. European Society for Medical Oncology (ESMO) meeting 2016, Poster: 248P

8. Manso L, et al. ONSITE study: Single arm, multicentre, non-randomized open-label trial to evaluate the safety of eribulin in third line chemotherapy in patients with HER2-negative metastatic or locally advanced breast cancer previously treated with anthracyclines and taxanes. European Society for Medical Oncology (ESMO) meeting 2016, Poster: 246P

9. Ortega V, et al. MERIBEL STUDY: Single-agent eribulin as first-line therapy for taxane-resistant HER2[-] metastatic breast cancer (MBC) patients (pts). European Society for Medical Oncology (ESMO) meeting 2016, Poster: 238P

10. Blay J, et l. Subgroup analysis of leiomyosarcoma (LMS) patients (pts) from a phase 3, open-label, randomized study of eribulin (ERI) versus dacarbazine (DTIC) in pts with advanced liposarcoma (LPS) or LMS. European Society for Medical Oncology (ESMO) meeting 2016, Poster: 1401PD

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

12. EUCAN 2015. Thyroid Cancer. Available at: http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=35 Accessed September 2016

13. Ljungberg B, et al. Epidemiology of Renal Cell Carcinoma. European Association of Urology, 2011; 60; 615-621

14. 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

15. Okamoto K, et al. Distinct binding mode of multikinase inhibitor lenvatinib revealed by biochemical characterization. ACS Medicinal Chemistry Letter 2010

16. SPC Lenvima (updated June 2015). Available at: http://www.medicines.org.uk/emc/medicine/30412  Accessed September 2016

17. SPC Kisplyx (updated September 2016). Available at: http://www.medicines.org.uk/emc/medicine/32335  Accessed September 2016.

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

19. Pollock R. Soft tissue sarcomas, A volume in the American Cancer Society Atlas of Clinical Oncology Series 2012

20. National Cancer Institute. Adult soft tissue cancer survival rates.

Available at:http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-survival-rates   Accessed September 2016

21. George S, et al. Systemic treatment of metastatic soft tissue sarcoma. Available at:http://hgp.gob.ec/index.html/uptodate/contents/mobipreview.htm?40/11/41146/abstract/4   Accessed September 2016

22. Cancer Research UK, Soft tissue sarcoma incidence statistics. Available at:  http://www.cancerresearchuk.org/cancer-info/cancerstats/types/soft-tissue-sarcoma/incidence   Accessed September 2016

23. SPC Halaven (updated August 2016). Available at: http://www.medicines.org.uk/emc/medicine/24382  Accessed September 2016

24. 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


 
September 2016 
Oncology-EU0042

 



 


Eisai


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