Eisai to present new data for lenvatinib in hepatocellular carcinoma and renal cell carcinoma at ESMO 2017 Congress

HATFIELD, England, September 4, 2017 /PRNewswire/ --

FOR EMEA MEDICAL MEDIA ONLY: NOT FOR AUSTRIAN/SWISS MEDIA  

• Health-related quality of life analysis of Phase III data for lenvatinib vs sorafenib in unresectable hepatocellular carcinoma to be presented in an oral proffered paper session^[1]
• Eisai data at the congress include Phase Ib/II results of lenvatinib in combination with pembrolizumab in patients with renal cell carcinoma^[5]

Eisai announced today clinical trial data from their oncology portfolio will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, being held on 8^th - 12^th September 2017. This will include data for lenvatinib in unresectable hepatocellular carcinoma (uHCC) and renal cell carcinoma (RCC).

An analysis of the pivotal Phase III REFLECT trial (Study 304) showing lenvatinib data on health-related quality of life and disease symptoms in patients with uHCC versus treatment with sorafenib will be presented in an oral proffered paper session on Sunday 10^th September.^[1] This additional information follows the results presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting, which demonstrated the treatment effect of lenvatinib on overall survival by statistical confirmation by non-inferiority to sorafenib, after many failed global Phase III trials involving multiple agents studied against sorafenib in advanced HCC.^[2] For a decade there has been no new approved medication in the first-line systemic treatment of uHCC in Europe^[3],[4]; Eisai submitted marketing authorisation to the European Medicines Agency, based on the REFLECT study.

Eisai will also present data on lenvatinib in patients with RCC, from a Phase Ib/II trial (Study 111) which evaluates the treatment of lenvatinib in combination with pembrolizumab in patients with selected solid tumours. The data show that lenvatinib in combination with pembrolizumab demonstrated promising antitumour activity and an acceptable safety profile in the RCC patient cohort.^[5] The results will be presented in an oral proffered paper session on Saturday 9^th September at the ESMO 2017 Congress.

The following abstracts for lenvatinib have also been accepted for presentation at the ESMO 2017 Congress:

• Network Meta-Analysis (NMA) of Treatments for Unresectable Hepatocellular Carcinoma (uHCC)^[6] - Abstract 3909:Tremblay G, et al.
  • Poster display session 707P, Hall 8  
  • Saturday 9^th September, 13:15 CEST  
• A Phase 2 Study of Lenvatinib Monotherapy as Second-line Treatment in Unresectable Biliary Tract Cancer: Primary AnalysisResults^[7] - Abstract 2304: Ikeda M, et al.
  • Poster display session 722P, Hall 8  
  • Saturday 9^th September, 13:15 CEST  
• Analysis of Serum Biomarkers (BM) in Patients (pts) from a Phase 3 Study of Lenvatinib (LEN) vs Sorafenib (SOR) as First-line Treatment for Unresectable Hepatocellular Carcinoma (uHCC)^[8] - Abstract 3193: Finn R, et al.
  • Proffered paper session LBA30, Barcelona Auditorium  
  • Sunday 10^th September, 11:45 - 12:00 CEST  
• Comparing ITC Results from Lenvatinib Plus Everolimus for Second-line Treatment of Advanced/Metastatic Renal Cell Carcinoma: Crossover Versus No Crossover^[9] - Abstract 3632: Garib S, et al.
  • Poster display session 878P, Hall 8  
  • Sunday 10^th September, 13:15 CEST  
• Impact of Duration of Dose Interruption on the Efficacy of Lenvatinib (LEN) in a Phase 3 Study in Patients (pts) With Radioiodine Refractory Differentiated Thyroid Cancer (RR-DTC)^[10] - Abstract 3074: Tahara M, et al.
  • Poster discussion session 434PD, Alicante Auditorium  
  • Monday 11^th September, 11:00 CEST  

"Eisai is excited by the range of abstracts to be presented at this year's congress, spanning numerous cancers that affect millions of patients across Europe. The breadth of data highlights our commitment to oncology and the discovery and development of innovative therapies from our portfolio that can make a difference and impact the lives of patients and their families. Our passion for people is part of our human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides," commented Gary Hendler, Chairman & CEO EMEA, Chief Commercial Officer, Oncology Business Group at Eisai.

About the REFLECT Trial (Study 304)^[2],[11]
REFLECT is an international, multicentre, open-label, randomised, non-inferiority Phase III study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in patients with uHCC. Patients (n=954) at 177 trial sites in 21 countries were randomised to receive lenvatinib 12 mg or 8 mg once a day depending on body weight (≥60 kg or <60 kg) (n=478) or sorafenib 400 mg twice a day (n=476). Treatment was continued until disease progression or unacceptable toxicity. The primary endpoint of this study was overall survival. The secondary efficacy endpoints of this study were progression-free survival, time to progression and objective response rate.

About Lenvatinib  
Lenvatinib, discovered and developed by Eisai, 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.^[12],[13]

About Eisai in Oncology   
Eisai is committed to the development and delivery of highly beneficial new treatments for people with cancer. The development of therapeutic options in oncology is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA). In the European Union, Eisai currently has three marketed treatments across four indications:

• Lenvima^® (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).^[14]
• Kisplyx^® (lenvatinib) is indicated in combination with everolimus in the European Union for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF)-targeted therapy.^[15]
• Halaven^® (eribulin) is indicated in the European Union for the treatment of adult patients 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. Halaven^® (eribulin) is also indicated in the European Union for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.^[16]

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 various 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 www.eisai.com.

References  
1. Vogel A, et al. Health-related quality of Life (HRQOL) and disease symptoms in patients with unresectable hepatocellular carcinoma (HCC) treated with lenvatinib (LEN) or sorafenib (SOR). European Society for Medical Oncology (ESMO) 2017 Congress; Abstract No. 3209.  
2. Cheng A, et al. Phase 3 trial of lenvatinib vs sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma (uHCC). American Society for Clinical Oncology annual meeting 2017; Abstract No. 4001. 
3. Nexavar Summary of Product Characteristics 2007. Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000690/WC500027704.pdf. Last accessed August 2017.  
4. European Medicines Agency. Nexavar Assessment History. Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000690/human_med_000929.jsp&mid=WC0b01ac058001d124. Last accessed August 2017.  
5. Lee CH, et al. A Phase 1b/2 Trial of Lenvatinib Plus Pembrolizumab in Patients With Renal Cell Carcinoma. European Society for Medical Oncology (ESMO) 2017 Congress; Abstract No. 3765. 
6. Tremblay G et al. Network Meta-Analysis (NMA) of Treatments for Unresectable Hepatocellular Carcinoma (uHCC). European Society for Medical Oncology (ESMO) 2017 Congress; Abstract No. 3909. 
7. Ikeda M et al. A Phase 2 Study of Lenvatinib Monotherapy as Second-line Treatment in Unresectable Biliary Tract Cancer: Primary Analysis Results. European Society for Medical Oncology (ESMO) 2017 Congress; Abstract No. 2304. 
8. Finn R et al. Analysis of serum biomarkers (BM) in patients (pts) from a phase 3 study of lenvatinib (LEN) vs sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC). European Society for Medical Oncology (ESMO) 2017 Congress; Abstract No. 3193. 
9. Garib S et al. Comparing ITC Results from Lenvatinib Plus Everolimus for Second-line Treatment of Advanced/Metastatic Renal Cell Carcinoma: Crossover Versus No Crossover. European Society for Medical Oncology (ESMO) 2017 Congress; Abstract No. 3632. 
10. Tahara M et al. Impact of Duration of Dose Interruption on the Efficacy of Lenvatinib (LEN) in a Phase 3 Study in Patients (pts) With Radioiodine Refractory Differentiated Thyroid Cancer (RR-DTC). European Society for Medical Oncology (ESMO) 2017 Congress; Abstract No. 3074.  
11. ClinicalTrials.gov. (2007) A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma. E7080-G000-304. Available at: clinicaltrials.gov/ct2/show/study/NCT01761266?term=E7080-G000-304&cond=Hepatocellular+Carcinoma&rank=1#locn. Last accessed August 2017.  
12. Matsui J, et al. (2008) 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. 122:664-671. 
13. Okamoto K, et al. (2014) Distinct Binding Mode of Multikinase Inhibitor Lenvatinib Revealed by Biochemical Characterization. ACS Medicinal Chemistry Letter. 
14. Lenvima Summary of Product Characteristics 2017. Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003727/WC500188674.pdf. Last accessed August 2017.  
15. Kisplyx Summary of Product Characteristics 2017. Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004224/WC500216237.pdf. Last accessed August 2017.    
16. Halaven Summary of Product Characteristics 2016. Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002084/WC500105112.pdf. Last accessed August 2017.

Lenvatinib-EU0105   
August 2017