MOST TRUSTED NEWSWIRE PRESS RELEASE DISTRIBUTION
PRTODAY / NewswireToday press release distribution service network
Written by / Agency / Source: IPSEN Group
Check Ads Availability|e-mail Article

Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

Ipsen Announces Phase 3 CELESTIAL Trial of Cabozantinib Meets Primary Endpoint of Overall Survival - Ipsen announces that phase 3 CELESTIAL trial of cabozantinib meets primary endpoint of overall survival in patients with advanced hepatocellular carcinoma [NASDAQ: EXEL] - Exelixis.com / IPSEN.com
Ipsen Announces Phase 3 CELESTIAL Trial of Cabozantinib Meets Primary Endpoint of Overall Survival

 

NewswireToday - /newswire/ - Paris, Ile-de-France, France, 2017/10/16 - Ipsen announces that phase 3 CELESTIAL trial of cabozantinib meets primary endpoint of overall survival in patients with advanced hepatocellular carcinoma [NASDAQ: EXEL] - Exelixis.com / IPSEN.com. Euronext: IPN; ADR: IPSEY

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma / BioTech / Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Ipsen (ipsen.com) and its partner Exelixis (exelixis.com) today announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC). The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. CELESTIAL is a randomized, global phase 3 trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. The safety data in the study were consistent with the established profile of cabozantinib.

In line with and in collaboration with our partner Exelixis, Ipsen expects to file in the first half of 2018 a variation of the initial application to the EMA and other relevant regulatory agencies and to evaluate potential next steps in the development strategy for cabozantinib outside the United States and Japan as a treatment for advanced HCC in patients who have been previously treated. Detailed results from CELESTIAL will be submitted for presentation at a future medical conference.

Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen, said: “Liver cancer is one of the leading causes of cancer deaths worldwide and more effective treatment options are urgently needed. We are pleased to report that in the CELESTIAL clinical study cabozantinib has been shown to provide a survival benefit and therefore has the potential to bring a new oral systemic treatment to previously treated patients with advanced liver cancer. ”

About the CELESTIAL Study
CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who previously received sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function. Enrollment of the trial was completed in September 2017, and 773 patients were ultimately randomized. Patients were randomized 2:1 to receive 60 mg of cabozantinib once daily or placebo and were stratified based on etiology of the disease (hepatitis C, hepatitis B or other), geographic region (Asia versus other regions) and presence of extrahepatic spread and/or macrovascular invasion (yes or no). No cross-over was allowed between the study arms.

The primary endpoint for the trial is OS, and secondary endpoints include objective response rate and progression-free survival. Exploratory endpoints include patient-reported outcomes, biomarkers and safety.

Based on available clinical trial data from various published trials conducted in the second-line setting of advanced HCC, the CELESTIAL trial statistics for the primary endpoint of OS assumed a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90 percent power to detect a 32 percent increase in median OS (HR = 0.76) at the final analysis. Two interim analyses were planned and conducted at 50 percent and 75 percent of the planned 621 events.

About HCC
Hepatocellular Carcinoma (HCC) is the most common form of liver cancer in adults.1 The disease originates in cells called hepatocytes found in the liver. With approximately 800’000 new cases diagnosed each year, HCC is the sixth most common cancer and the second-leading cause of cancer deaths worldwide.2,3 According to the GLOBOCAN data, it is estimated that across the European Union (EU-28) nearly 60’000 new patients will be diagnosed with liver cancer in 2020.4 Without treatment, patients with the disease in advanced stage usually survive between 4 and 8 months.5

About CABOMETYX® (cabozantinib)
Cabometyx® is an oral small molecule inhibitor of receptors, including VEGFR, MET, AXL and RET. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance.

In February of 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. This agreement was amended in December of 2016 to include commercialization rights for Ipsen in Canada. On April 25, 2016, the FDA approved Cabometyx® tablets for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy and on September 9, 2016, the European Commission approved Cabometyx® tablets for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland. Cabometyx® is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.

Ipsen also submitted to European Medicines Agency (EMA) the regulatory dossier for cabozantinib as a treatment for first-line advanced RCC in the European Union on August 28, 2017; on September 8, 2017, Ipsen announced that the EMA validated the application.

Cabozantinib is not approved for the treatment of advanced hepatocellular carcinoma.

References
1. McGlynn KA, London WT. The Global Epidemiology of Hepatocellular Carcinoma, Present and Future. Clinics in liver disease. 2011;15(2):223-x. doi:10.1016/j.cld.2011.03.006.
2. Ferlay J, Soerjomataram I, Dikshit R, et al: Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 136:E359-86, 2015.
3. GLOBOCAN International Agency for Research on Cancer (IARC).
4. GLOBOCAN International Agency for Research on Cancer (IARC).

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma / BioTech / Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: IPSEN Group

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick NewswireToday Visibility Checker

 

Distribution / Indexing: [+]  / [Company listed above is a registered member of our network. Content made possible by PRZOOM / PRTODAY indexing services]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma / BioTech / Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


Ipsen Announces Phase 3 CELESTIAL Trial of Cabozantinib Meets Primary Endpoint of Overall Survival

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name NewswireToday and LINK as the source.
 
Publisher Contact: Didier Véron - IPSEN.com 
+33(0)1 58 33 51 16 didier.veron[.]ipsen.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any IPSEN Group securities in any jurisdiction including any other companies listed or named in this release.

Pharma / BioTech / Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY

Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From IPSEN Group / Company Profile


Read Pharma / BioTech / Nutrition Most Recent Related Newswires:

Ipsen Showcases Commitment to Patient-centric Advances in Oncology with Record Number of Abstracts to be Presented At ESMO 2020 Virtual Congress
Global Phase 3 Clinical Study of Pridopidine in Huntington’s Disease Announced
Ipsen to Present New Insights At ASBMR for Potential Treatment of Ultra-rare Disease Fibrodysplasia Ossificans Progressiva (FOP)
Ipsen to Present Results from MOVE, the First Global Phase III Trial in Fibrodysplasia Ossificans Progressiva (FOP) At ASBMR 2020 Annual Meeting
DSM Ignites New Strategic Initiative to Transform Global Animal Nutrition and Health
Jamjoom Pharmaceuticals Earns Acclaim from Frost & Sullivan for its Dominance in the KSA Pharma Market
DSM and Avril Complete Creation of Joint Venture to Develop Plant-based Protein
Ipsen Joins Clinical Collaboration to Evaluate Cabozantinib (CABOMETYX®) Plus Atezolizumab in Metastatic Non-small Cell Lung Cancer
Stevanato Group, SCHOTT, and Gerresheimer Confirm the Readiness to Support Future Covid-19 Vaccine with Pharmaceutical Containers
Ipsen Receives FDA Fast Track Designation for Liposomal Irinotecan (ONIVYDE®) as A First-line Combination Treatment for Metastatic Pancreatic Cancer
Ipsen Demonstrates Continued Commitment to Rare Diseases with Eight Abstracts Accepted At ENDO 2020 Published in the Journal of the Endocrine Society
Waters Corporation Earns New Product Innovation Award with First SmartMS-enabled Biopharmaceutical Solution
DSM Boosts Maternal and Infant Nutrition Portfolio with New Plant-based High Potency DHA Oil
Ipsen Enters into an Option Agreement with IRICoR and Université de Montréal for A Discovery-stage Oncology Program
Ipsen Announces Positive Topline Results from Pivotal Phase III CheckMate -9ER Trial Evaluating CABOMETYX®

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  BizJobs.com

Visit  JobsWare.com





 
  ©2020 NewswireToday — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com newswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)