New Data for Halaven® (eribulin), Lenvima® (lenvatinib) and Kisplyx® (lenvatinib) Demonstrate Continued Strength of Eisa

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)  

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