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
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.

References

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=le
nvatinib+and+rcc&rank=1 Accessed 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

Lenvatinib-EU0078

ots Originaltext: Eisai
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Eisai
Cressida Robson / Ben Speller
+44 7908 314 155 / +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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