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 (ots/PRNewswire) -

FOR EMEA MEDIA ONLY: NOT FOR AUSTRIAN/SWISS JOURNALISTS

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 (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