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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
SmartStream Steps Ahead with New Industry Digital Payments Solution23.10.2018 02:01 | Tiedote
SmartStream Technologies, the financial Transaction Lifecycle Management (TLM®) solutions provider, today announced the launch of TLM Aurora, the next generation of Corona, the industry’s leading reconciliation platform – the first new module is designed to support the new industry standards in the digital payments world, by providing connectors to SWIFT GPI, RTGS, as well as Blockchain based networks, allowing for real-time operational control, proactive exception management and low TCO. TLM Aurora provides the new generation of integrated operational control for the digital marketplace. As transactions increase in variability, velocity and volume, the need for scalable, real-time, integrated reconciliations is greater than ever. TLM Aurora supports organisations in performing operations such as SWIFT and SEPA transfers, mobile, cash and card payments, digital currencies, settlements and reconciliations. The solution is agile enough to support the smallest of organisations and can be
CoreLogic to Acquire Symbility Solutions Inc.23.10.2018 01:12 | Tiedote
CoreLogic (NYSE: CLGX), a leading global provider of property information, insight, analytics and data-enabled solutions, today announced the Company has entered into a definitive agreement to acquire the outstanding shares of Symbililty Solutions Inc. (“Symbility”) (TSX.V: SY) not already owned by CoreLogic. CoreLogic currently holds approximately a 28% ownership interest in Symbility. Symbility, founded in 2004, is a leading provider of subscription and cloud-based property insurance claims workflow solutions for the Property & Casualty insurance industry. Symbility also provides an extensive array of innovative enterprise mobile and application software solutions. The company is headquartered in Toronto, Canada and operates in the U.S., Canada, the United Kingdom, Germany, Netherlands, Australia and New Zealand. “Symbility expands our footprint in property and casualty insurance domestically and in key markets around the globe. Further scaling our insurance and international footpri
Pacific Drilling Awarded Contract for the Pacific Bora23.10.2018 00:00 | Tiedote
Pacific Drilling S.A. (OTC: PACDQ) (“Pacific Drilling” or the “Company”) announced today that its deepwater drillship the Pacific Bora has been awarded a contract by Nigerian Agip Exploration Limited (a subsidiary of Eni SpA) for drilling operations in Nigeria. The term of the contract is for one firm well plus two additional option wells. The contract is expected to commence in mid to late November 2018 and firm contract backlog is estimated at $9 million. Pacific Drilling Chief Executive Officer Paul Reese commented: “On the heels of our previous announcement of new work for Pacific Santa Ana in Mauritania, we are pleased to have secured this contract for the Bora which reflects our substantial experience in Nigeria and our uninterrupted commitment to providing exceptional drilling services to our clients.” Currently offshore Abidjan, Côte d'Ivoire, the Pacific Bora is a sixth generation deepwater, dynamically-positioned drillship capable of operating in water depths up to 10,000 fee
ResMed Wins German Patent Infringement Case Against Fisher & Paykel22.10.2018 23:30 | Tiedote
ResMed (NYSE: RMD) (ASX: RMD), the world’s leading tech-driven medical company and innovator in sleep apnea and respiratory care, today announced the results of a court and patent office ruling in Germany in ResMed’s favor. A trial court ruling from the Munich District Court states that the headgear used on two Fisher & Paykel CPAP masks – the Simplus full face and Eson 2 nasal mask – infringes ResMed patent EP 2 373 368 B1 in Germany. In a separate decision, the Opposition Division of the European Patent Office had already decided that the patent asserted against Fisher & Paykel is valid. Each decision may be appealed by Fisher & Paykel. “We applaud the Munich District Court for reaching this just finding, and are exploring all options in light of the fact that Fisher & Paykel is selling CPAP masks with headgear that infringes a valid ResMed patent in Germany,” said ResMed Chief Administrative Officer and Global General Counsel David Pendarvis. “We will continue to defend our intellec
Grand Prize Winner in $1.75M Water Abundance XPRIZE Announced at XPRIZE Visioneering 201822.10.2018 20:49 | Tiedote
During Visioneering 2018, XPRIZE’s annual gathering of philanthropists and innovators to evaluate concepts for future competitions, the Foundation revealed the results of its latest, completed XPRIZE. The Skysource / Skywater Alliance was announced as the grand prize winner of the $1.75M Water Abundance XPRIZE, a two-year competition aimed at alleviating the global water crisis with energy-efficient technologies that harvest fresh water from thin air. In addition at Visioneering, five new prize concepts were evaluated with top honors going to a prize concept called “Coral Survival”, a prize designed to protect and restore coral reefs. This prize will move forward into the XPRIZE pipeline. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181022005795/en/ The Skysource / Skywater Alliance team, based in Venice Beach, California, wins the Water Abundance XPRIZE (Photo: Business Wire) The Water Abundance XPRIZE, powered by the Tat
Positive Trial Results with Filgotinib in Psoriatic Arthritis and Ankylosing Spondylitis Both Published in The Lancet22.10.2018 20:15 | Tiedote
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that detailed results from two clinical trials evaluating filgotinib, an investigational, selective JAK1 inhibitor, for the treatment of psoriatic arthritis and ankylosing spondylitis were both published in The Lancet. The publication of the Phase 2 EQUATOR data also coincides with a plenary session presentation at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting. “The results of the EQUATOR and TORTUGA studies demonstrate that filgotinib improved the signs and symptoms of patients with psoriatic arthritis whose disease had not responded to prior therapies and independently, for those with ankylosing spondylitis,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “These findings represent an important step forward in our efforts to improve outcomes for people livin
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