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Press Release

Eisai enrolls patients in global phase III trial to evaluate first-line Kisplyx® (lenvatinib) plus pembrolizumab or everolimus versus sunitinib in advanced renal cell carcinoma

Posted on: 03 Oct 16

Hatfield, UK, – 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® by Merck, Sharp & Dohme (MSD) in the European Union.


Study 307 ( 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,[ii]


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).[iii]


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.[iv]


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.


Editor's Details

Mike Wood

Last updated on: 03/10/2016

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