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 Positive Topline Results from Pivotal Phase III CheckMate -9ER Trial Evaluating CABOMETYX® - Ipsen announces positive topline results from pivotal Phase III CheckMate -9ER trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) in previously untreated advanced renal cell carcinoma - IPSEN.com
Ipsen Announces Positive Topline Results from Pivotal Phase III CheckMate -9ER Trial Evaluating CABOMETYX®

 

NewswireToday - /newswire/ - Paris, Ile-de-France, France, 2020/04/20 - Ipsen announces positive topline results from pivotal Phase III CheckMate -9ER trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) in previously untreated advanced renal cell carcinoma - 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!


 

• Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib;
• CABOMETYX in combination with Opdivo demonstrates clinically meaningful efficacy results across all endpoints and preliminary assessment showing a favorable safety profile;
• Trial co-funded by Bristol Myers Squibb, Exelixis, Ipsen and Takeda.

Ipsen announced today that CheckMate -9ER, a pivotal Phase III trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met its primary endpoint of progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).

The safety profiles of CABOMETYX and Opdivo observed in the trial reflect the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line RCC.

“We are delighted that this pivotal CheckMate -9ER trial met its key efficacy measures of progression-free survival as well as overall survival for previously untreated kidney cancer patients, with a favorable safety profile. These positive topline results support the growing body of data that shows CABOMETYX® may create a more immune-permissive tumor environment that could enhance the response to immune checkpoint inhibitors,” said Dr. Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen. “We look forward to discussing these results with global health authorities with the aim to bring this new combination regimen to previously untreated kidney cancer patients, a population that, despite recent advances, remains in need of additional therapeutic options that extend survival.”

“CheckMate -9ER marks an important milestone in our partnership with Exelixis to further develop CABOMETYX® and our shared vision to progress the treatment for cancers and indications with high unmet need. If approved, this combination may become an important new first-line option for patients with this cancer,” said Bartek Bednarz, Senior Vice President, Global Product & Portfolio Strategy at Ipsen. “We would like to thank the patients, their families and the healthcare professionals involved in the trial and we look forward to presenting detailed results of the study at an upcoming congress.”

For more information on the details of the trial results, please see the Exelixis Form 8-K on file here.

The companies plan to submit detailed results of CheckMate -9ER for presentation at an upcoming medical conference. More information about this trial is available at ClinicalTrials.gov/.

About the trial
CheckMate -9ER is an open-label, randomized, multi-national Phase III trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma. Patients are randomized 1:1 to Opdivo and CABOMETYX or sunitinib. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS) and objective response rate (ORR). The primary efficacy analysis is comparing the doublet combination versus sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

About renal cell carcinoma
There are over 400,000 new cases of kidney cancer diagnosed worldwide each year.1 Of these, renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for approximately 90% of cases.2 It is twice as common in men, and male patients account for over two thirds of deaths.1 If detected in the early stages, the five-year survival rate is high, but for patients with advanced (aRCC) or late-stage metastatic RCC, the survival rate is much lower, around 12%, with no identified cure for this disease.4,5

About Ipsen products
This press release mentions investigational uses of Ipsen products. Product indications and approvals for use vary by jurisdiction; please see SmPC/PI for full indications and safety information.

About Ipsen
Ipsen (ipsen.com) is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas Oncology, Neuroscience and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2019, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,800 employees worldwide.

Contacts:
Financial Community: Eugenia Litz - Vice President, Investor Relations
P: +44(0)17 5362 7721 - E: eugenia.litz[.]ipsen.com.

Fanny Allaire - Senior Director, France Hub, Global Communications
P: +33(0)1 58 33 58 96 - E: fanny.allaire[.]ipsen.com.

Myriam Koutchinsky - Investor Relations Manager
P: +33(0)1 58 33 51 04 - E: myriam.koutchinsky[.]ipsen.com.

References

1. GLOBOCAN 2018. Kidney Cancer Factsheet. Last accessed: April 2020.
2. Mayo Clinic. Kidney Cancer. Last accessed: April 2020.
3. National Cancer Institute. Renal Cell Cancer. Last accessed: April 2020.
4. American Cancer Society. Survival rates for kidney cancer. Last accessed: April 2020.
5. Renal cell carcinomas epidemiology in the era of widespread imaging. Journal of Clinical Oncology.

 
 
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 Positive Topline Results from Pivotal Phase III CheckMate -9ER Trial Evaluating CABOMETYX®

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: Christian Marcoux - IPSEN.com 
+33(0)1 58 33 67 94 christian.marcoux[.]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:

Huami Corp and Royal DSM Announce Collaboration on Wearable Technologies and Health Tracking for Personalized Nutrition
DSM Expands Animal Nutrition & Health Operations in China with Opening of Seventh Premix Plant
Biosurfactants and Natural Preservatives Drive Innovation for Functional Ingredients in Personal Care Market Finds Frost & Sullivan
Ypsomed Collaborates with SCHOTT and Lonza to Develop A Comprehensive Solution for Combination Products Based on Patch Injectors
DSM Unveils Purpose-led Brand Strategy Marking Transition to End-to-end Partner in Nutrition and Health
Ipsen to Present 12 Abstracts At the 11th World Congress for Neurorehabilitation (WCNR) Virtual Congress
Imec Announces elPrep5 - the Newest Version of its Software Platform for DNA Analysis
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

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  BizJobs.com

Visit  Limelon Advertising, Co.





 
  ©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)