Ipsen receives validation from European Medicines Agency for the application of a new indication for Cabometyx® (cabozantinib) for first-line treatment of advanced renal cell carcinoma in adults
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Medicines Agency (EMA), the European regulatory authority, has validated the application for variation to the Cabometyx® (cabozantinib) marketing authorization for the addition of a new indication in first-line treatment of advanced renal cell carcinoma.
The filing is based on the results of CABOSUN, a phase II trial demonstrating that Cabometyx® prolongs progression free survival (PFS) in treatment-naive patients with intermediate- or poor-risk aRCC compared to sunitinib, the standard of care for more than 10 years. If approved, Cabometyx® would be the first and only single-agent treatment to demonstrate superior clinical efficacy over the standard of care in both first line (vs. sunitinib) and second line (vs. everolimus) aRCC.
Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen, said: “The filing is based on the results of CABOSUN, a phase II trial demonstrating that Cabometyx ® prolongs progression free survival (PFS) in a statistically and clinically meaningful way in treatment-naive patients with intermediate- or poor-risk advanced RCC compared to sunitinib, the standard of care for more than 10 years. Ipsen's commitment to oncology and developing innovative therapies for cancer patients is stronger than ever. We continue to be excited about our partnership with Exelixis to investigate new indications for cabozantinib."
In September 2016, Cabometyx® was approved in the EU for the treatment of aRCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. As of today, Cabometyx® is commercially available for the treatment of eligible patients with advanced RCC in Austria, Denmark, Germany, Luxembourg, Norway, The Netherlands, Spain and UK.
About advanced Renal Cell Carcinoma
With the incidence predicted to rise 22% by 2020, renal cell carcinoma (RCC) threatens to become one of the fastest growing cancers in the world.2 Targeted therapies including tyrosine kinase inhibitors (TKIs) of the VEGF receptor (VEGFR) introduced a decade ago, significantly transformed the treatment landscape of aRCC.3
The American Cancer Society’s 2017 statistics cite kidney cancer as one of the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.4 Clear cell RCC is the most common type of kidney cancer in adults.5 If detected in its early stages, the five-year survival rate for RCC is high. For patients with advanced- or late-stage metastatic RCC, however, the five-year survival rate is only 12% with no identified cure for the disease.6 Approximately 30,000 patients in the U.S. and 68,000 globally require treatment.7
The majority of clear cell RCC tumors have lower than normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL, and VEGF.8-9 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness, and metastasis.10, 11, 12, 13 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors. xii - xv
About Cabometyx ® (cabozantinib)
Cabometyx® is the tablet formulation of cabozantinib. Its targets include MET, AXL, and VEGFR receptors in tumor cells. 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. Cabometyx® is available in 20 mg, 40 mg, or 60 mg doses. The recommended dose is 60 mg orally, once daily.
On April 25, 2016, the FDA approved Cabometyx® tablets for the treatment of patients with aRCC who have received prior anti-angiogenic therapy. On August 16, 2017, Ipsen’s partner Exelixis has submitted a U.S. supplemental new drug application for cabometyx® (cabozantinib) for the treatment of previously untreated advanced kidney cancer. On September 9, 2016, the European Commission approved Cabometyx® tablets for the treatment of aRCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway, and Iceland. On September 8, 2017, the EMA validated the application for Cabometyx® for the treatment in first line aRCC.
About the CABOSUN study
On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS compared with sunitinib in patients with intermediate- or poor-risk aRCC per IMDC (International Metastatic RCC Carcinoma Database Consortium) criteria as determined by investigator assessment. CABOSUN was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the NCI-CTEP. These results were first presented by Dr. Toni Choueiri at the meeting of the European Society for Medical Oncology (ESMO) 2016, and published in the Journal of Clinical Oncology (Choueiri, JCO, 2017).14
On June 19th 2017 Exelixis announced that the analysis of the review by a blinded independent radiology review committee (IRC) has confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS) from the CABOSUN randomized phase 2 trial of cabozantinib as compared with sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria. Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS. The incidence of adverse events (any grade) and the incidence of grade 3 or 4 adverse events between cabozantinib and sunitinib were comparable.
CABOSUN is a randomized, open-label, active-controlled phase II trial that enrolled 157 patients with aRCC determined to be intermediate- or poor-risk per IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, four weeks on followed by two weeks off). The primary endpoint was PFS. Secondary endpoints included overall survival and objective response rate. Eligible patients were required to have locally advanced or metastatic clear-cell RCC, ECOG performance status 0-2, and had to be intermediate- or poor-risk per IMDC criteria (Heng, JCO, 2009).15 Prior systemic treatment for RCC was not permitted.
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 close to €1.6 billion in 2016, 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 5,100 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 Choueiri, Toni K et. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. The Lancet Oncology, Volume 17 , Issue 7 , 917 – 927, July 2016
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 Jacobsen J, Grankvist K, Rasmuson T, et al. Expression of vascular endothelial growth factor protein in human renal cell carcinoma. BJU Int. 2004;93:297–302.
4 American Cancer Society. Cancer Facts & Figures 2017. Atlanta: American Cancer Society; 2017.
5 Jonasch E., Gao J., Rathmell W.K., Renal cell carcinoma. BMJ. 2014; 349:g4797.
6 Ko, J. J., Choueiri, T.K., et al. First-, second- third-line therapy for mRCC: benchmarks for trial design from the IMDC. British Journal of Cancer. 2014; 110: 1917-1922.
7 Decision Resources Report: Renal Cell Carcinoma. October 2014 (internal data on file).
8 Harshman, L.C. and Choueiri, T.K., Targeting the hepatocyte growth factor/c-Met signaling pathway in renal cell carcinoma. Cancer J. 2013; 19(4):316-23.
9 Rankin et al., Direct regulation of GAS6/AXL signaling by HIF promotes renal metastasis through SRC and MET. Proc Natl Acad Sci U S A. 2014; 111(37):13373-8.
10 Zhou L, Liu X-D, Sun M, et al. Targeting MET and AXL overcomes resistance to sunitinib therapy in renal cell carcinoma. Oncogene. 2016;35(21):2687–2697.
11 Koochekpour et al.,The von Hippel-Lindau tumor suppressor gene inhibits hepatocyte growth factor/scatter factor-induced invasion and branching morphogenesis in renal carcinoma cells. Mol Cell Biol. 1999; 19(9):5902–5912.
12 Takahashi A, Sasaki H, Kim SJ, et al. Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor in renal cell carcinoma associated with angiogenesis. Cancer Res.1994;54:4233-4237.
13 Nakagawa M, Emoto A, Hanada T, Nasu N, Nomura Y. Tubulogenesis by microvascular endothelial cells is mediated by vascular endothelial growth factor (VEGF) in renal cell carcinoma. Br J Urol. 1997;79:681-687
14 Choueiri, T.K., et al. Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial. Journal of Clinical Oncology. 2017; 35:6, 591-597.
15 Heng D.Y., Xie W., Regan M.M., et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: Results from a large, multicenter study. Journal of Clinical Oncology. 2009; 27:5794-5799.
For further information:
Didier Véron, +33 (0)1 58 33 51 16
Senior Vice-President, Public Affairs and Communication
Brigitte Le Guennec, +33 (0)1 58 33 51 17
Corporate External Communication Manager
Eugenia Litz, +44 (0) 1753 627721
Vice-President Investor Relations
Côme de la Tour du Pin, +33 (0)1 58 33 53 31
Investor Relations Executive
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 tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
California Sports Surfaces Announces New Senior Leadership22.9.2017 23:21 | Tiedote
The California Sports Surfaces (CSS) brand, as part of ICP Construction (ICP), today announces the appointments of Steve Lock as global vice president; John Graham as leader, strategic accounts and global relationships; and Malcolm Parkes as managing director, Australia California Sports Surfaces. CSS is the leading supplier of such prestigious sports surfacing solutions as DecoTurf, Plexicushion Prestige, Rebound Ace, Premier Sports Coatings, Premier Court and Plexitrac. These world-renowned product lines supply the US Open, the Australian Open and other distinguished sporting events. Steve Lock has assumed the role of global vice president, responsible for managing the US and global sales and marketing teams for California Sport Surfaces. He was previously the leader for California Sports Surfaces in Australia and the Asia/Pacific region, and will be relocating to ICP global headquar
CORRECTING and REPLACING Smiths Detection Wins Biggest Ever Single Order for Next-Generation Hold Baggage Scanner for Frankfurt Airport22.9.2017 19:02 | Tiedote
Please replace the release with the following corrected version due to multiple revisions to the headline, subhead and body of the release. The corrected release reads: SMITHS DETECTION WINS BIGGEST EVER SINGLE ORDER FOR NEXT-GENERATION HOLD BAGGAGE SCANNER FOR FRANKFURT AIRPORT Advanced HI-SCAN 10080 XCT hold baggage scanners offer flexible, sophisticated detection capabilities Smiths Detection has won its largest single order ever for its advanced HI-SCAN 10080 XCT hold baggage scanners, with an associated eight-year service agreement. The contract covers 35 of our HI-SCAN 10080 XCT next-generation scanners to support the upgrade to the ECAC Standard 3 explosives detection systems. The solution will deliver increased security and operational efficiency, and can easily be upgraded to mee
California Sports Surfaces’ Rebound Ace Portable Court to be Used at Inaugural Laver Cup22.9.2017 17:37 | Tiedote
California Sports Surfaces (CSS), a brand under ICP Construction (ICP), is pleased to announce its innovative Rebound Ace Portable sport surfacing system is being used in the inaugural Laver Cup in Prague, Czech Republic, Sept. 22-24, 2017. CSS’s Rebound Ace system was selected to provide comfort, consistency and playability to the Laver Cup participants, who represent the best tennis players in the world. For this event, organizers worked with California Sports Surfaces to create a stunning black surface that would keep spectators focused on the game play. Rebound Ace Portable is an interlocking, temporary court system that provides premium cushion and comfort to maximize players’ performance. It has been chosen for use for several high-profile events, including the Fed Cup, Davis Cup, and the Singapore-based WTA Finals, for which it was specifically created. Laver Cup is modeled afte
Mobile RPG ‘King’s Raid’ Set to Launch in European Markets22.9.2017 14:00 | Tiedote
Mobile RPG “King’s Raid” which was launched in February in Korea, North America and SEA, is officially launching in European Markets (Google Play and Apple App Store) this month. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170922005006/en/ Mobile RPG King’s Raid is officially launching in European Markets (Google Play and Apple App Store). It is a Character Collection mobile RPG game full of charming characters and high-end graphics. It includes real-time PvP and large scale Raid content. King’s Raid was launched in February in Korea, North America, and SEA. King’s Raid developed by Vespa Interactive went viral and became a hot Mobile RPG even with limited marketing and lack of brand recognition. As it slowly made the charts in Popularity and Grossing Sales in both markets, it succeeded in reaching the Top 5 in both major App markets in Korea within a month
Smiths Detection is Supplying the Latest Technology for ECAC Standard 3 EDS Upgrade at Frankfurt Airport22.9.2017 14:00 | Tiedote
Smiths Detection is providing the latest hold baggage scanning technology to support the upgrade to ECAC Standard 3 explosives detection systems at Frankfurt Airport. Awarded by the Procurement Office of the Federal Ministry of the Interior in Germany, the contract includes 35 x HI-SCAN 10080 XCT next generation scanners which will not only detect the explosive threats specified by the new standard, but can also easily be upgraded to meet future requirements to identify evolving threats, such as homemade explosives. Frankfurt is Europe’s second largest airport in terms of cargo and fourth in passenger numbers (over 60 million in 2016) and these figures are expected to continue growing. The new technology will deliver the security and operational efficiencies required by such a busy airport both now and into the future. For deployment ahead of the upcoming ECAC deadline of 20
IBC2017 Reports Record Visitor Numbers in Its 50th Year22.9.2017 12:32 | Tiedote
In its 50th anniversary, IBC2017 has confirmed a year-on-year increase in visitor numbers, marking a record attendance of 57,669 across the six day event. Visitors from across the expanding media ecosystem had the opportunity to learn about the opportunities offered by technologies - including social media TV, OTT, VR, AR, Cloud, IP, Bots and 5G - and to meet the most intelligent robots. Visitors to the 15 exhibition halls witnessed many exciting new launches; Launch Pad grew year-on-year with a record number of exhibitors; the Future Reality Theatre and Content Everywhere Hub free programmes were packed with diverse and new exciting content, embracing the transformation. Conference delegates packed the Forum to hear from leading experts from Facebook, Google, CNN, HTC Viveport, Dolby, C4 and ITV to discuss and debate the hot topics challenging the industry with a focus on m
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