Eisai Enrols Patients in Global Phase III Trial to Evaluate First-line Kisplyx® (lenvatinib) Plus Pembrolizumab or Everolimus Versus Sunitinib in Advanced Renal Cell Carcinoma[1]

HATFIELD, England, October 3, 2016 /PRNewswire/ --


Eisai today announces the initiation of a multicentre, global, randomised phase III study that will evaluate the efficacy and safety of lenvatinib in combination with anti-PD-1 immunotherapy pembrolizumab and lenvatinib in combination with everolimus versus sunitinib in patients with advanced renal cell carcinoma (RCC) in a first-line setting. Pembrolizumab is marketed under the brand name Keytruda(R) by Merck, Sharp & Dohme (MSD) in the European Union.

Study 307 (ClinicalTrials.gov identifier: NCT02811861) (Comparison of the efficacy and safety of Lenvatinib in combination with Everolimus or pembrolizumab versus sunitinib alone in first-line treatment of subjects with Advanced Renal cell carcinoma) is designed to assess the progression-free survival (PFS) of patients treated with these combinations. [1] Secondary endpoints include objective response rate, overall survival and safety. Study 307 is the first phase III trial to assess lenvatinib in combination with pembrolizumab, an anti-PD-1 (programmed death receptor-1) immunotherapy, in previously untreated patients with advanced RCC.[1][2]

Kidney cancer is among the ten most frequently occurring cancers in Western (countries) communities.[3] About 270,000 cases of kidney cancer are diagnosed globally each year and 116,000 people die from the disease.[3] Approximately 90% of all kidney cancers are renal cell carcinomas (RCC).[3]

In August 2016, the European Commission issued a 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.[4]

The continued development of its oncology portfolio underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of oncology and to addressing the unmet medical needs of people with cancer and their families.

Notes to Editors    

About Study 307   

Study 307, a phase III clinical trial, will enrol 735 patients with advanced RCC who have not received any previous systemic therapy.[1] Patients will be randomised 1:1:1 to receive a combination of lenvatinib (20 mg orally, once daily) plus pembrolizumab (200 mg intravenously, every 3 weeks); lenvatinib (18 mg orally, once daily) plus everolimus (5 mg orally, once daily); or sunitinib (50 mg orally, once daily), on a schedule of four weeks on treatment followed by two weeks off treatment).[1] The primary endpoint of this study is PFS; other endpoints include objective response rate (ORR), overall survival (OS) and safety.[1]

More information about Study 307 may be found on ClinicalTrials.gov identifier: NCT02811861

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.[5],[6]

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).[7] 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.

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.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com.


1. ClinicalTrials.gov. Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma. Verified June 2016 by Eisai Inc. Available at: https://clinicaltrials.gov/ct2/show/NCT02811861?term=lenvatinib+and+rcc&rank=1 Access ed September 2016

2. SPC Keytruda (updated September 2016) Available at: https://www.medicines.org.uk/emc/medicine/30602 Accessed September 2016

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

4. SPC Kisplyx (updated September 2016). Available at: https://www.medicines.org.uk/emc/medicine/32335 Accessed September 2015

5. 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. International Journal of Cancer, 2008;122:664-671

6. Okamoto K, et al. Distinct Binding Mode of Multikinase Inhibitor Lenvatinib Revealed by Biochemical Characterization. ACS Medicinal Chemistry Letter, 2014;6:89-94

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

September 2016



CONTACT: Media Enquiries: Eisai, Cressida Robson / Ben Speller , +44 7908314 155 / +44 7908 09416, Cressida_Robson@eisai.net, Ben_Speller@eisai.net,Tonic Life Communications, Alex Davies / Callum Haire, +44 7720 496 472 /+44 7867 429 637, Alex.Davies@toniclc.com, Callum.Haire@toniclc.com

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