Erdafitinib Phase 2 Study Results Show Promise in the Treatment of Metastatic Urothelial Cancer
The Janssen Pharmaceutical Companies of Johnson & Johnson announced findings today from a Phase 2 study that showed treatment with erdafitinib resulted in durable responses in patients with metastatic or surgically unresectable urothelial cancer (mUC) and fibroblast growth factor receptor alterations (FGFRalt). This is a patient population with high unmet need based on poor outcomes when treated with available therapies. Erdafitinib is a once-daily pan-FGFR inhibitor.1 FGFRs are cell proteins that, if altered, can contribute to the development of cancer.1 Alterations occur in approximately 20 percent of mUC patients.1 The results were presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting in Chicago (Abstract #4503) and have been selected for the Best of ASCO Meetings.1
“I am very encouraged by these Phase 2 data showing that erdafitinib had promising response rates and progression-free survival in a patient population with such high unmet need,” said Dr. Yohann Loriot, Senior Consultant, Department of Cancer Medicine & INSERM, Institut Gustave Roussy, University of Paris Sud, Villejuif, France. “Currently there are no targeted therapies approved for specific subsets of patients with urothelial cancer who have genetic alterations. While immune checkpoint inhibitors have led to improvements in outcomes for these patients, we are still finding that many patients do not respond to treatment.”
BLC2001 (NCT02365597) is a multicentre, open-label Phase 2 study evaluating the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic urothelial cancer, whose tumours have certain FGFR alterations.1 Ninety-nine patients were treated with an optimised dosing schedule using pharmacodynamically guided dose up-titration: a starting dose of erdafitinib at 8 mg daily, with the possibility to increase the dose to 9 mg daily based on serum phosphate levels.2 Twelve percent of patients were chemo-naïve, 89 percent of patients had received one or more lines of therapy, 43 percent of patients had received two or more prior lines of therapy, and 78 percent of patients had visceral metastases.2 There was a 40 percent confirmed overall response rate1 (RECIST 1.1;* 3% Complete Response, 37% Partial Response), a median progression-free survival of 5.5 months and median overall survival of 13.8 months.2 In patients who experienced grade 3 adverse events (AEs), the most common were, stomatitis (9%) and diarrhoea (4%).1 Seven patients discontinued due to treatment-related AEs.2
“These study results are very promising, particularly as this is an area of high unmet need with patients who otherwise have very limited treatment options remaining. We hope that the response rates shown by erdafitinib could eventually give patients with metastatic or surgically unresectable urothelial cancer a new treatment option,” said Dr Ivo Winiger-Candolfi, Europe, Middle East and Africa (EMEA) Oncology Therapeutic Area Lead, Janssen. “The successful development of new oncology therapies, such as erdafitinib, is an example of our precision medicine approach: providing the right patient, with the right treatment, at the right time. We recognise that every patient is unique and that by accounting for individual differences in people’s genes, environments and lifestyles, we can optimise the therapeutic benefit for particular groups of patients. We look forward to understanding the potential efficacy and broader safety profile of erdafitinib in both Phase 3 development as well as in combination with anti-PD1 therapy.”
*RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors which is a standard way to measure how well a cancer patient responds to treatment and is based on whether tumours shrink, stay the same, or get bigger.3
About Urothelial Cancer
Europe has among the highest incidence rates of bladder cancer in the world and mortality rates for men are by far the highest recorded worldwide.4 It is the fifth most frequently diagnosed cancer in the EU, with about 124,000 new cases each year for both sexes.5 The majority (90%) of bladder cancer consists of urothelial carcinoma in Western Europe.6 Urothelial bladder cancer starts in the bladder lining (urothelial cells or transitional cells) and can be non-invasive or invasive.7 For patients with metastatic disease, outcomes can be poor due to the often rapid progression of the tumour and the lack of efficacious treatments.8 The relative five-year survival rate for patients with metastatic disease is five percent.9
Erdafitinib is a once-daily oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor being evaluated by Janssen Research & Development in Phase 2 and 3 clinical trials in patients with advanced urothelial cancer.10 FGFRs are a family of receptor tyrosine kinases which may be upregulated in various tumour cell types and may be involved in tumour cell proliferation, tumour angiogenesis and tumour cell survival.11 In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Therapeutics Ltd. to develop and commercialise erdafitinib.
Erdafitinib received Breakthrough Therapy Designation from the U.S. Food and Drug Administration in March 2018.12 The aim is to move towards regulatory submission with the Phase 2 data and continue to pursue erdafitinib in Phase 3 clinical development, as well as in combination with anti-PD-1 therapy.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news.
Cilag GmbH International; Janssen Biotech, Inc.; Janssen Oncology, Inc. and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding erdafitinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, the Janssen Pharmaceutical Companies of Johnson & Johnson and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Siefker-Radtke AO, Necchi A, Park SH, et al. First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt). J Clin Oncol. 2018;36(Suppl.):abstract 4503.
2 Siefer-Radtke AO, et al. First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt). Oral presentation at ASCO Annual Meeting, Chicago, IL, USA; 1-5 June 2018.
3 National Cancer Institute. NCI Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/recist. Accessed May 2018.
4 Antoni S, Ferlay J, Soerjomataram I, Znaor A, Jemal A, Bray F. Bladder cancer incidence and mortality: a global overview and recent trends. Eur Urol. 2017;71:96-108.
5 European Commission. Epidemiology of bladder cancer in Europe. Available at: https://ec.europa.eu/jrc/en/publication/epidemiology-bladder-cancer-europe Last accessed May 2018.
6 Wong MC, Fung FD, Leung C, Cheung WW, Goggins WB, Ng CF. The global epidemiology of bladder cancer: a joinpoint regression analysis of its incidence and mortality trends and projection. Sci Rep. 2018;8:1129.
7 Macmillan Cancer Support. Types of bladder cancer. Available at: https://www.macmillan.org.uk/information-and-support/bladder-cancer/non-invasive-bladder-cancer/understanding-cancer/types-of-bladder-cancer.html Last accessed May 2018.
8 Waldron, Nick et al, Current management of advanced bladder cancer. Available at: https://onlinelibrary.wiley.com/doi/pdf/10.1002/tre.603. Last accessed May 2018.
9 National Cancer Institute. Cancer Stat Facts: Bladder Cancer. Available at: https://seer.cancer.gov/statfacts/html/urinb.html. Last accessed May 2018.
10 Tabernero J, Bahleda R, Dienstmann R, Infante JR, Mita A, Italiano A, Calvo E, Moreno V, Adamo B, Gazzah A, et al. Phase I dose-escalation study of JNJ-42756493, an oral pan-fibroblast growth factor receptor inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2015;33:3401–3408. doi: 10.1200/JCO.2014.60.7341.
11 National Cancer Institute. NCI Drug Dictionary: pan FGFR kinase inhibitor BGJ398. Available at: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pan-fgfr-kinase-inhibitor-bgj398 Last accessed May 2018.
12 Janssen. Janssen announces U.S. FDA breakthrough therapy designation for erdafitinib in the treatment of metastatic urothelial cancer. Press release March 15, 2018. Available at: http://www.janssen.com/janssen-announces-us-fda-breakthrough-therapy-designation-erdafitinib-treatment-metastatic Last accessed May 2018.
Mobile: +353 (0)85-744-6696
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
Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 17:00 | Tiedote
Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With
Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 16:41 | Tiedote
Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel
Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 15:00 | Tiedote
Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i
Announcement by Viking Corp on Tecnotree22.6.2018 14:09 | Tiedote
In the interests of stakeholder transparency, this announcement provides background and context to Viking's file bankruptcy proceedings upon Tecnotree: As many of you will now know, Viking Corp was recently forced to file bankruptcy proceedings upon Tecnotree, which were withdrawn on the 19 June. In the interests of stakeholder transparency, we make this Announcement to provide background and context to this action. Firstly, we would reflect on the recent history of our attempts to partner with Tecnotree and all its stakeholders. Viking launched a Tender Offer (TO), having conducted detailed discussions with the Tecnotree Board and our advisors. On the basis of those discussions, we were very confident that the TO price of 10 cents per share provided truly superior value for shareholders. So did the Tecnotree Board as evidenced by their unanimous recommendation of our Offer and of course, further evidenced by the current prevailing market price. This TO was supported in the most vigoro
HeartSciences Named “Start-Up to Watch”22.6.2018 14:00 | Tiedote
HeartSciences is delighted to have been highlighted as “Start-Up to Watch” in the June 8, 2018 issue of the MedTech Strategist. The article titled “HEARTSCIENCES: ARTIFICIAL INTELLIGENCE IMPROVES FRONTLINE RISK STRATIFICATION FOR HEART DISEASES” discusses HeartSciences’ role in addressing the current challenges and significant unmet need to identify heart disease at an early stage and reduce the high prevalence of expensive diagnostic testing with low yields. The article highlights the enormous opportunity for HeartSciences’ breakthrough MyoVista® Wavelet ECG (wavECG™) technology to benefit patients and to reduce health system costs and references a recently published study titled “Prediction of Abnormal Myocardial Relaxation From Signal Processed Surface ECG” in the Journal of American College of Cardiology (JACC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005088/en/ MyoVista Wavelet ECG Cardiac Testing Device (P
High-Performance Solutions and Complete Protection for Critical Installations: the Latest Innovations from CNIM and Its Bertin Subsidiary to Be Unveiled at WNE 201822.6.2018 12:39 | Tiedote
The third edition of the World Nuclear Exhibition – major event for the global nuclear energy community – will be held at Paris-Villepinte, June 26 th to 28 th , 2018. CNIM and Bertin Technologies , leading players in the fields of nuclear equipment, safe handling and instrumentation for the complete protection of nuclear power plants, will be unveiling their joint offerings at this exhibition (booth D125-Hall 7). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005185/en/ CNIM's high safety fuel handling systems (Photo: Business Wire) Based on its long experience of major nuclear projects and its cutting-edge industrial capabilities, CNIM’s offering reflects its ability to innovate and adapt to the most difficult environments. Highlights on its exhibition booth will include: The design and manufacturing of high-safety fuel handling systems (notably the design of three remotely operated spent fuel handling and transferri
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