People with Advanced Renal Cell Carcinoma in Sweden, Norway, Denmark and Finland Now Able to Benefit from Kisplyx® (Lenvatinib) in Combination with everolimus

DANDERYD, Sweden, October 18, 2016 /PRNewswire/ --

FOR NORDICS MEDIA ONLY - NOT FOR SWISS / AUSTRIAN JOURNALISTS   

New treatment option shown to extend progression-free survival significantly in people with advanced renal cell carcinoma^[1]

Kisplyx^® (Lenvatinib) in combination with everolimus is now available in Sweden, Norway, Denmark and Finland for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.^[1]

Renal cell carcinoma accounts for approximately 80-90% of all kidney cancers, with few treatment options for this cancer at an advanced stage.^[2] Approximately 30,000 people live with kidney cancer throughout Sweden, Norway, Denmark and Finland,^[3] with more than 3,500 new diagnoses each year.^[2]

"For patients in Sweden, Norway, Denmark and Finland, access to a treatment option proven to delay the progression of their cancer is a welcome development. Lenvatinib also has a high objective response rate, especially when compared with either treatment alone. The phase II trial was the first in which these two types of cancer drugs have been successfully combined in renal cell carcinoma" comments Michael Szeps, Eisai Nordic Medical Director.

The availability of the combination in the Nordics follows the evaluation of results from a pivotal Phase II trial, which showed that lenvatinib plus everolimus significantly extended progression-free survival in patients with unresectable advanced renal cell carcinoma versus everolimus alone.^[1] The pivotal Phase II study evaluated 153 people living with advanced renal cell carcinoma who had progressed after one previous VEGF therapy.^[1] Patients experienced a median progression-free survival of 14.6 months when treated with lenvatinib in combination with everolimus (n=51), compared with 5.5 months for those who received everolimus alone (n=50) (HR 0.40; 95% CI: 0.24-0.67; p=0.0005).^[1] Updated median overall survival in the study population was 25.5 months in the lenvatinib plus everolimus group compared with 15.4 months in the everolimus group (HR 0.59; 95% CI 0.36 - 0.97). An objective response was achieved by 22 (43%) of 51 patients allocated lenvatinib plus everolimus compared with three (6%) of 50 who received single-agent everolimus (p<0.0001) and 14 (27%) of 52 patients assigned single agent

lenvatinib (p=0.10).^[1]

For lenvatinib in combination with everolimus, the most common any-grade treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhoea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher were diarrhoea, fatigue and hypertension.^[1]

Lenvatinib selectively inhibits the kinase activities of several different receptors including vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), RET, KIT and platelet-derived growth factor receptors (PDGFR).^[4] Recent additional data in human RCC xenograft models indicate that lenvatinib in combination with everolimus causes significant antitumour effects through the potent antiangiogenic activity of lenvatinib and direct antitumour activity of everolimus.^[5]

In May 2016, the US Food and Drug Administration (FDA) approved lenvatinib in combination with everolimus, for the treatment of patients with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy.

Lenvatinib has been approved for the treatment of radio-iodine refractory thyroid cancer in the United States, Europe, Russia, Switzerland, Australia, Canada, Israel, Singapore, Japan, South Korea and Brazil.

The development of lenvatinib 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 well-being of people worldwide. Eisai is committed to the therapeutic area of oncology and to addressing the unmet medical needs of patients and their families.

Notes to Editors  

About Everolimus  

Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor. mTOR is a key serine-threonine kinase, the activity of which is known to be upregulated in a number of human cancers.^[6]

About Eisai EMEA 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 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).
• Kisplyx^® (lenvatinib) is indicated 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.
• Halaven^® (eribulin) is indicated for the treatment of people with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens 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 for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

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.

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 http://www.eisai.com.

References   

1. Kisplyx SPC (Updated September 2016) Available at: https://www.medicines.org.uk/emc/medicine/32335 Accessed October 2016

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

3. Engholm G et al. NORDCAN: Cancer Incidence, Mortality, Prevalence and Survival in the Nordic Countries, Version 7.3 (08.07.2016) Available at: http://www-dep.iarc.fr/NORDCAN/english/frame.asp Accessed October 2016

4. Matsui J, et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumour activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008;122:664-671

5. Adachi Y, et al. Lenvatinib in Combination with Everolimus Demonstrated Enhanced Antiangiogenesis and Antitumour Activity in Human RCC Xenograft Models. AACR 2016; #3264

6. SPC Afinitor. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001038/WC500022814.pdf Accessed October 2016

October 2016
Lenvatinib-EU0079

SOURCE Eisai