Eisai Submits Marketing Authorisation Application to the European Medicines Agency for Lenvatinib in First-Line Hepatocellular Carcinoma

  • Lenvatinib filing based on pivotal Phase III REFLECT study demonstrating non-inferior overall survival compared to sorafenib  
  • Simultaneous submissions to EMA and US FDA follow filing with Japan's MHLW in June 2017  
Eisai announced it has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the first-line use of lenvatinib in patients with unresectable hepatocellular carcinoma (uHCC). Patients with hepatocellular carcinoma face a poor prognosis, with a complex disease which accounts for approximately 90% of liver cancer cases worldwide.[1]
"For a decade there has been no advance in the first-line systemic treatment of unresectable hepatocellular carcinoma in Europe," said Professor Jeff Evans, Professor of Translational Cancer Research, University of Glasgow. "There is a significant unmet need for patients with this advanced form of liver cancer, where treatment options are limited."
The EMA submission is based on results of the pivotal Phase III REFLECT study (Study 304). Lenvatinib was the only first-line agent to demonstrate non-inferior overall survival (OS) versus sorafenib in uHCC, with a significant and clinically meaningful improvement versus sorafenib in all secondary efficacy endpoints of progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR).[2] The REFLECT study results were presented in an oral session at this year's American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and will be published soon in the peer-reviewed journal The Lancet.
"This announcement represents another important milestone for lenvatinib in difficult-to-treat cancer types," said Gary Hendler, Chairman & CEO EMEA, Chief Commercial Officer, Oncology Business Group at Eisai. "Based on the results observed in the REFLECT trial we are looking forward to working with the EMA to bring a much-needed first-line new treatment option for liver cancer patients in Europe one step closer."  
Lenvatinib is currently approved in the EU 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).[3] Lenvatinib is also approved in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF)-targeted therapy.[4]
Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides.
About the REFLECT Trial (Study 304)  
REFLECT is an international, multicentre, open-label, randomised, non-inferiority Phase III study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in patients with uHCC. Patients (n=954) at 183 trial sites in 21 countries were randomised to receive lenvatinib 12 mg or 8 mg once a day depending on body weight (≥60 kg or <60 kg) (n=478) or sorafenib 400 mg twice a day (n=476). Treatment was continued until disease progression or unacceptable toxicity. The primary endpoint of this study was overall survival. The secondary efficacy endpoints of this study were progression-free survival, time to progression and objective response rate.
The median OS for patients treated with lenvatinib was 13.6 months (95% CI: 12.1 - 14.9 months) compared to 12.3 months (95% CI: 10.4 - 13.9 months) for sorafenib (HR: 0.92; 95% CI: 0.79 - 1.06).[2] Median PFS was 7.4 months (95% CI: 6.9-8.8 months) with lenvatinib with a median TTP of 8.9 months (95% CI; 7.4-9.2 months) compared to median PFS of 3.7 months (95% CI: 3.6-4.6 months) (HR: 0.66; 95% CI: 0.57 - 0.77; p<0.00001) and median TTP of 3.7 months on sorafenib (95% CI; 3.6-5.4 months) (HR 0.63; 95% CI; 0.53 - 0.73; p<0.00001).[2] In addition, lenvatinib demonstrated significantly higher ORR (24%) compared to sorafenib (9%) (odds ratio: 3.13; 95% CI: 2.15-4.56; p<0.00001).[2] ORR was evaluated using mRECIST.[2]
The most common treatment-emergent adverse events (TEAEs) of any grade among patients who received lenvatinib were hypertension (42.2%), diarrhoea (38.7%), decreased appetite (34.0%), and decreased weight (30.9%).[2] In the sorafenib arm, the most common TEAEs were palmar-plantar erythrodysesthaesia (hand-foot syndrome) (52.4%), diarrhoea (46.3%), hypertension (30.3%), and decreased appetite (26.3%).[2] TEAEs occurred in 98.7% of patients in the lenvatinib arm and 99.4% in the sorafenib arm of the study.[2]
About Hepatocellular Carcinoma (HCC)  
Hepatocellular carcinoma (HCC) is a complex disease associated with a poor prognosis and accounts for approximately 90% of liver cancer cases worldwide.[1] The incidence of liver cancer in Europe has been rising steadily over the past decade.[5] uHCC is an advanced hard-to-treat stage of liver cancer that affects >70% of patients.[6] HCC is the second most common cause of death from cancer worldwide, estimated to be responsible for nearly 746,000 deaths across the globe in 2012.[7] In Europe an estimated 71,000 people were diagnosed with liver cancer and 69,000 people died from this disease in 2012.[7]
About Lenvatinib  
Lenvatinib, discovered and developed by Eisai, 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.[8],[9] Lenvatinib is approved in the EU and the US for specific patient populations:
In the European Union lenvatinib is indicated:
  • Under the brand name Lenvima® 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).[3]
  • Under the brand name Kisplyx® in combination with everolimus in the European Union for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF)-targeted therapy.[4]
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 various 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 www.eisai.com.
Source:http://markets.businessinsider.com/news/stocks/Eisai-Submits-Marketing-Authorisation-Application-to-the-European-Medicines-Agency-for-Lenvatinib-in-First-Line-Hepatocellular-Carcinoma-1002205172

Comments

Post a Comment

Popular posts from this blog

EMA validates Incyte’s MAA for retifanlimab to treat metastatic squamous cell anal carcinoma

Incyte, global biopharmaceutical company, announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group vice president, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent US Food & Drug Administration acceptance of our Biologics License Application for Priority R...
Read more

Tumour-targeting drug paves way for bone cancer treatment

 The treatment of osteosarcoma, the most common tumour of bone, is challenging, but a new study is offering hope to the patients with this disease. The study led by The University of  Texas MD Anderson Cancer Centre  found that a drug, known as bone metastasis-targeting peptidomimetic (BMTP-11), has potential as a new therapeutic strategy for this devastating illness. Results from the preclinical study looked at BMTP-11 alone and in combination with the chemotherapy agent gemcitabine. Although osteosarcoma is a relatively rare cancer, it is a leading disease-related cause of death in children and young adults ages 10 to 20. However, over the last 25 years, the five-year survival rate has remained unchanged, and the treatment options for these patients are few. In addition, the side effects of available treatment options often are significant and cumulative, and may cause other health problems and damage to major organs. "What's novel about this treatment is that...
Read more

Merck’s Keytruda plus platinum- and fluoropyrimidine-based chemotherapy receives US FDA nod to treat certain patients with locally advanced/metastatic esophageal or GEJ carcinoma

Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for Keytruda plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, Keytruda plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death...
Read more