Ipsen Announces EMA Validation of Filing of a New Application for Additional Indication for Cabometyx®, for Patients with Previously Treated Advanced Hepatocellular Carcinoma (HCC)
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Medicines Agency (EMA), the European regulatory authority, has validated the filing of a new application for an additional indication for Cabometyx®, for patients with previously treated advanced Hepatocellular Carcinoma (HCC).
The filing is based on the results of the global placebo-controlled phase 3 CELESTIAL trial which met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant improvement and clinically meaningful improvement in median OS compared with placebo in patients with advanced hepatocellular carcinoma who have been previously treated with sorafenib.
Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen, said:
“This milestone is an important step forward for the cabozantinib ongoing development program across solid tumors, with the potential, if approved, to provide patients with advanced HCC - which is still an unmet medical need - with a new oral systemic treatment."
CELESTIAL is a randomized, double-blind, placebo-controlled global phase 3 study of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. The study was 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.
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. The safety data in the study were consistent with the established profile of cabozantinib.
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.
On September 8, 2017, Ipsen announced that the EMA validated the application for cabozantinib as a treatment for first-line advanced RCC in the European Union; on March 22 2018, the CHMP issued a positive opinion for this indication.
On December 19, 2017, Exelixis received approval from the FDA for Cabometyx® for the expanded indication of treatment of advanced RCC.
Cabozantinib is not approved for the treatment of advanced hepatocellular carcinoma.
Ipsen 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, Neurosciences 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 €1.9 billion in 2017, 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 5,400 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2016 Registration Document available on its website (www.ipsen.com).
1. McGlynn KA, London WT. The Global Epidemiology of Hepatocellular
Carcinoma, Present and Future. Clinics in liver disease.
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). Available at: http://gco.iarc.fr/today/fact-sheets-cancers?cancer=7&type=0&sex=0
4. GLOBOCAN International Agency for Research on Cancer (IARC). Available at: http://globocan.iarc.fr/Pages/burden_sel.aspx
5. Annals of Oncology 23 (Supplement 7): vii41–vii48, 2012
Ian Weatherhead, +44 (0) 1753 627733
Vice President, Corporate External Communications
Brigitte Le Guennec, +33 (0)1 58 33 51 17
Senior Manager, Global External Communications
Eugenia Litz, +44 (0) 1753 627721
Vice-President Investor Relations
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Thales and Gemalto Announce Regulatory Clearance from the Minister of Innovation in Canada14.8.2018 19:00 | Tiedote
Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto today announce that they have received foreign investment Regulatory Clearance in Canada. Together with the anti-trust clearance obtained in China and Israel, and clearance relating to foreign investments in Australia, Thales and Gemalto have obtained 4 of the required 14 Regulatory Clearances. Thales and Gemalto continue to work constructively with the competent antitrust authorities to obtain the remaining
BCW Acquires Creative Powerhouse HZ, Significantly Expanding Expertise in Integrated Communications14.8.2018 17:26 | Tiedote
BCW (Burson Cohn & Wolfe), a leading global communications agency and a WPP company, today announced it has acquired HZ, one of the largest independent, digitally driven, integrated creative agencies in the U.S. Headquartered in Rockville, Maryland with offices in Baltimore, Los Angeles, New York and Washington, D.C., the acquisition will add the capability of HZ’s nearly 200 creative and digital professionals to BCW’s deep expertise in integrated communications across all industry sectors. HZ’s wide-ranging offerings include a full spectrum of multichannel digital design and development, mobile activation, social media, brand and identity creation, content, film and video production, search marketing (SEO/SEM), data and analytics as well as integrated media solutions. HZ’s broad client base spans the consumer, hospitality, food & beverage, education, B2B, real estate, sports & entertainment, healthcare and technology industries and counts Hilton Worldwide, Salesforce.org and Tishman S
Andersen Global Initiates Expansion in Mozambique14.8.2018 16:30 | Tiedote
Andersen Global continues expansion in Africa with Isalcio Mahanjane e Associados, a law firm headquartered in Maputo, Mozambique. The collaboration with Isalcio Mahanjane e Associados signifies Andersen’s growth in the African region, as Mozambique provides strategic coverage in Southeast Africa and is the sixth country to collaborate or join in Africa in the past 14 months. Led by Managing Partner Isalcio Mahanjane, the firm includes 10 professionals and specializes in providing quality services in all branches of law for corporations and individuals. These services include commercial and corporate law, banking and financial law, labor law, real estate management, oil and gas, mines, and law and administrative litigation. “Mozambique will be a key point of connectivity with our practice in Portugal as we continue to focus on best-in-class solutions in Africa,” commented Global Chairman and Andersen Tax LLC CEO, Mark Vorsatz. “Isalcio and his team are passionate about their practice a
CTS Engines Inducts First PW2000 Engine14.8.2018 15:00 | Tiedote
CTS Engines, the global leader for mature engine maintenance within the Aerospace & Defense industry, announced today that it had inducted the first PW2000 engine into its engine overhaul facility in Ft. Lauderdale, FL. Along with the CF6-80C2, CF6-80A, and CF6-50C2, the PW2000 represents the fourth engine model type serviced by CTS. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180814005021/en/ PW2000 Engine. (Photo: Business Wire) “The profile of the PW2000 engine—which will continue to operate on B757s in cargo configuration and on C-17 Globemaster military transport aircraft for years to come—is an ideal fit for the CTS product line,” said Vesa Paukkeri, CTS’s President and Chief Operating Officer. “CTS is the go-to independent jet engine MRO for sunset engines operating in cargo and military transport configurations. We look forward to servicing this engine through the remainder of its time on wing over the next 30+ ye
Gyeonggi Province of Korea Launches Beyond the Dream Global VLOG Contest14.8.2018 15:00 | Tiedote
Gyeonggi Provincial Government and Gyeonggi Tourism Organization (GTO) are hosting an international video contest called “Beyond the Dream VLOG Contest 2018.” Video submissions will be accepted until August 26, 2018 (Korean Standard Time). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180814005240/en/ Gyeonggi Provincial Government and Gyeonggi Tourism Organization (GTO) are hosting an international video contest called "Beyond the Dream VLOG Contest 2018." Video submissions will be accepted until August 26, 2018 (Korean Standard Time). The goal of the "Beyond the Dream VLOG Contest 2018" is to raise global awareness of Gyeonggi Province as an attractive travel destination and to select a Gyeonggi-do tourism ambassador who will show the world the charms of the province. Four final-winning teams will win a 10 day trip to Gyeonggi Province. USD 10,000 travel expenses for airline tickets and other travel expenses will be provi
BOC Group has just released ADONIS:CE – A Milestone in Free Cloud BPM Tools!14.8.2018 14:00 | Tiedote
BOC Group announces the release of brand new ADONIS:Community Edition, now available in the cloud for free. Today, BOC Group launched the next in line descendent of its worldwide-known free Business Process Management tool, ADONIS:CE. This launch is more than just a product update: it marks the ADONIS:Community Edition's shift to the battle-tested web-platform and its transition to the cloud as SaaS. Based on the latest version of BPM suite's commercial edition ADONIS NP 5.5, ADONIS:CE makes a grand entrance with its fresh design, state-of-the-art functionality and exceptional user experience. Tobias Rausch, ADONIS product manager elaborates: “We believe in spreading BPM to all regions, as well as teams and companies of all sizes, by providing a free-of-charge tool that helps businesses improve their process game. That is why we have designed a freely available BPM tool with such an outstanding and rich feature-set.” In addition to the capabilities mentioned above, ADONIS:CE comes with
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme