Data at ASCO Show Consistent Progression-Free Survival Benefit in Relapsed/Refractory Chronic Lymphocytic Leukaemia Patients Treated with Imbruvica®▼ (ibrutinib), Including Those with High-Risk Disease, with Up to Four Years of Follow-Up
5.6.2017 15:00 | Business Wire
Janssen-Cilag International NV (“Janssen”) today announced longer follow-up of up to four years from the pivotal Phase 3 RESONATE™ trial (PCYC-1112) of Imbruvica®▼ (ibrutinib) vs. ofatumumab in patients with relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL). At a median follow-up of 44 months, the results demonstrated three year progression-free survival (PFS) rate of 59% vs. 3% with ibrutinib vs. ofatumumab respectively.1 A consistent PFS benefit with ibrutinib was observed across all baseline disease and patient characteristics, particularly among patients with genetic mutation deletion 11q (del11q),1 which is a prognostic feature usually conferring an increased risk for poor outcomes. With longer follow-up the overall response rate (ORR) has now reached 91%, with a complete response or complete response with incomplete bone marrow recovery (CR/CRi) rate of 9% (abstract #7510).1
These results will be presented today at the 53rd Annual American Society of Clinical Oncology (ASCO) Meeting in Chicago (poster session: 8:00 a.m. – 11:30 a.m. CDT; poster discussion: 1:15 p.m. – 2:30 p.m. CDT). Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.
“These findings demonstrated the continued benefit of ibrutinib in previously treated chronic lymphocytic leukaemia,” said John C. Byrd, M.D., Distinguished University Professor at the Ohio State University Comprehensive Cancer Center and lead investigator of the study.* “Importantly, with long-term follow-up, many patients receiving ibrutinib had a deepening of responses and continued improvement in progression-free survival. This study confirms ibrutinib as a major therapeutic option for chronic lymphocytic leukaemia patients.”
CLL is typically a slow-growing blood cancer of the white blood cells.2 The incidence of CLL in Europe among men and women is approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.3 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.4
“With up to four-year follow-up data, we are continuing to grow the evidence base for ibrutinib and we continue to be impressed by its durability and control for patients with relapsed or refractory chronic lymphocytic leukaemia,” said Dr Catherine Taylor, Haematology Therapeutic Area Lead, Janssen Europe, Middle East and Africa. “Janssen Oncology is committed to addressing critical unmet need in B-cell malignancies and ibrutinib is an example of how we pursue the cancer types we know best in order to deliver first-in-class, breakthrough therapies to patients.”
Abstract #7510 : Long-Term Efficacy and Safety with Ibrutinib (ibr) In Previously Treated Chronic Lymphocytic Leukemia: Up to Four Years Follow-Up of The RESONATE Study (Poster Board: #272) 1
- Poster session: Monday, June 5, 8:00 AM - 11:30 AM CDT
- Poster discussion session: Monday, June 5, 1:15 PM - 2:30 PM CDT
At up to four years of follow-up (median, 44 months and max 53 months), ibrutinib continued to show efficacy in CLL patients (n=391), with PFS significantly longer with ibrutinib compared to ofatumumab (median not reached vs. 8.1 months, respectively; Hazard Ratio [HR] 0.133; p<0.0001; three year PFS 59% vs. 3%).1 Ibrutinib also demonstrated benefit in high-risk patient subgroups, i.e. deletion 17p (del17p) and del11q, with PFS in the del11q subgroup showing the most favourable outcome which was noninferior to patients without these cytogenetic abnormalities.1 At time of analysis, with a majority of patients in the ofatumumab (68%) arm crossing over to the ibrutinib arm, three year overall survival (OS) was longer for ibrutinib vs. ofatumumab (median OS was not reached for either arm).1 The OS rate for single agent ibrutinib at three years was 74% and the ORR was 91% with CR/CRi increasing over time to 9%.1 Baseline cytopenias improved with extended ibrutinib therapy for haemoglobin (85%), platelet (95%) and absolute neutrophil counts (95%).1
The adverse event (AE) profile of ibrutinib included major haemorrhage, Grade ≥3 atrial fibrillation and Grade ≥3 hypertension occurring in 6%, 6%, and 8% of patients, respectively, over a follow-up period of up to four years.1 Incidence of most Grade ≥3 AEs decreased from year one vs. year two to three: neutropenia (18% vs. 8%); pneumonia (11% vs. 4%); atrial fibrillation (4% vs. 2%), respectively.1 Discontinuations were most frequently caused by progressive disease (27%) and AEs (12%).1 At analysis, 90 ibrutinib patients (46%) continued the therapy in the study.1
RESONATETM, a Pharmacyclics-sponsored Phase 3 randomised, multi-centre, open-label, international study, enrolled 391 patients with R/R CLL, who had received at least one prior therapy and were not considered appropriate candidates for treatment with a purine analog (median age 67). Study participants were treated with either 420 mg oral ibrutinib (n=195) once-daily until progression or unacceptable toxicity or intravenous ofatumumab for up to 24 weeks (n=196, initial dose of 300 mg followed by 11 doses at 2,000 mg per dose and schedule consistent with local labelling). The results showed significant improvements in PFS vs. ofatumumab, meeting the study’s primary endpoint, and in OS and ORR, meeting the study’s key secondary endpoints. Primary results from this trial were featured in the official press program at ASCO 2014, with a simultaneous publication in the New England Journal of Medicine in July 2014.5 The results were also the basis for the European Commission approval of ibrutinib in R/R CLL in October 2014.6
Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B cells.7 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.8
Ibrutinib is currently approved in Europe for the following uses:9
- As a single agent for the treatment of adult patients with previously untreated CLL, adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy.
- As a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Please see the ibrutinib summary of product characteristics for further information.9
CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years, according to the stage of disease.10 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options each time. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.
About the Janssen Pharmaceutical Companies
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 on www.twitter.com/janssenEMEA for our latest news.
Cilag GmbH International; Janssen Biotech, Inc.; and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
# # #
*Disclaimer: Dr. Byrd served as an investigator of this Pharmacyclics-sponsored clinical study. Dr. Byrd does not have a financial interest in the company.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the potential of ibrutinib and expectations for its further development. 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, any of the other Janssen Pharmaceutical Companies 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 behavior 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 January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent 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 or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1. Byrd JC, Hillmen P, O’Brien S, et al. Long-term efficacy and safety with ibrutinib (ibr) in previously treated chronic lymphocytic leukemia (CLL): Up to four years follow-up of the RESONATE study. J Clin Oncol. 2017;35(Suppl.):abstract 7510.
2. American Cancer Society. About chronic lymphocytic leukemia. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8679.00.pdf Last accessed May 2017.
3. Sant M, Allemani C, Tereanu C, et al. Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project. Blood. 2010;116:3724-34.
4. Eichhorst B, Dreyling M, Robak T, et al. Chronic lymphocytic leukemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2011;22(Suppl.6):vi50–vi54.
5. Byrd JC, Brown JR, O’Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371:213-23.
6. European Medicines Agency. IMBRUVICA (ibrutinib): authorisation details. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003791/human_med_001801.jsp&mid=WC0b01ac058001d124 Last accessed May 2017.
7. O’Brien S, Furman RR, Coutre SE, et al. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet Oncol. 2014;15:48-58.
8. European Medicines Agency. EPAR summary for the public: Imbruvica (ibrutinib). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003791/WC500177778.pdf Last accessed May 2017.
9. Imbruvica Summary of Product Characteristics, March 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdf. Last accessed May 2017.
10. Sagatys EM, Zhang L. Clinical and laboratory prognostic indicators in chronic lymphocytic leukemia. Cancer Control. 2012;19:18-25.
+353 85 744 6696
+1 732 524 3922
Joseph J. Wolk
+1 732 524 1142
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
Watch BizWireTV: A Camera You Can Wear and Krispy Kreme’s Famous Donuts Get Eclipsed with Chocolate17.8.2017 15:08 | Tiedote
On BizWireTV, catch some Quick Biz Hits and see the latest in Star Power. Also see what’s happening in the startup world with the Accelerator Report, featuring the VC Watch and this week’s Startup Standout. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005305/en/ BizWireTV is hosted by Jordyn Rolling (Photo: Business Wire Now you can watch BizWireTV, and the latest breakthroughs in tech from the biggest brands, on any screen you want by downloading the new app through the Apple TV and iPhone App Store and Google Play for Android devices. Top of the Wire Introducing FrontRow: the camera re-invented. Watch BizWireTV to see more disruptors as well as the top 5 trending stories of the week! A core c
PsiOxus Therapeutics Announce Two New Board Appointments: New Board Appointments Strengthen Company’s US Presence17.8.2017 10:00 | Tiedote
PsiOxus Therapeutics, Ltd. (PsiOxus) today announced the appointment of Charles Rowland and Duncan Higgons to the Board of Directors as part of an ongoing drive to expand in the US. Charles Rowland was most recently the President and Chief Executive Officer (CEO) of Aurinia Pharmaceuticals, a clinical stage pharmaceutical company focused on the global lupus nephritis market. Prior to this, he served as the Vice President and Chief Financial Officer (CFO) of ViroPharma, during which time the company grew into a global biopharmaceutical business with $500 million in annual revenues until it was acquired by Shire plc for $4.2 billion. Before joining ViroPharma, Mr. Rowland was executive Vice President, CFO, and interim co-CEO, for Endo Pharmaceuticals. In his earlier career, Charles held finance and operational positions at Biovail Pharmaceuticals, Breakaway Technologies, Pharmacia
Smarsh Adds Voice Archiving Offering with Acquisition of London-Based Cognia17.8.2017 09:59 | Tiedote
Smarsh®, providing information archiving solutions for compliance, e-discovery and risk management, has completed the acquisition of Cognia, a worldwide leader in cloud-based voice archiving, audio search and analytics. Smarsh will leverage Cognia’s intellectual property and development resources to offer its global customer base enhanced capabilities around mobile and fixed-line voice communication – alongside a market-leading range of electronic communications – within The Archiving Platform. The acquisition will expand the existing presence of Smarsh in Europe and is central to its MiFID II compliance solution for financial firms. In addition to capturing incoming and outgoing communication from fixed-line recording solutions, Cognia uniquely captures voice content directly from leading mobile carriers. Carrier-direct capture is the most reliable and automated method for capt
Schlumberger Announces Third-Quarter 2017 Results Conference Call17.8.2017 00:23 | Tiedote
Schlumberger Limited (NYSE:SLB) will hold a conference call on October 20, 2017 to discuss the results for the third quarter ending September 30, 2017. The conference call is scheduled to begin at 8:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 288-8967 within North America or +1 (612) 333-4911 outside of North America approximately 10 minutes prior to the start of the call, and ask for the “Schlumberger Earnings Conference Call.” A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call,
Rimini Street Named to Inc. 5000 List for Seventh Consecutive Year16.8.2017 21:20 | Tiedote
Rimini Street, Inc., a global provider of enterprise software products and services, and the leading independent support provider for Oracle and SAP products, today announced that it was named to Inc. magazine’s 36th annual Inc. 5000 list for the seventh consecutive year. The Inc. 5000 list is an exclusive ranking of the nation’s fastest-growing private companies and represents the most comprehensive look at America’s entrepreneurs. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005908/en/ Rimini Street has earned a place on the annual Inc. 5000 list since 2011, joining an elite group – approximately 2% – of Inc. 5000 honorees to ever achieve this milestone. (Photo: Business Wire) Rimini Street has earned a place on the annual Inc. 5000 list since 2011, joining an elite group – approximatel
Keio Plaza Hotel Tokyo Starts "Ikebana" Flower Arrangement Workshops16.8.2017 17:00 | Tiedote
Keio Plaza Hotel Tokyo, one of Japan’s most prestigious international hotels located in Shinjuku, Tokyo, starts special 45 minute classes to teach overseas guests about “Ikebana” flower arrangement which will be held on every other Thursday beginning from August in a private room for JPY3,000 per participant. Instruction and commentary will be provided by the renowned flower arrangement artist Hiroki Maeno. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005431/en/ From August, 2017, Keio Plaza Hotel Tokyo starts special 45 minute classes to teach overseas guests about "Ikebana" flower arrangement workshops. (Photo: Business Wire) Flower arrangement artist Hiroki Maeno has created special and unique flower arrangements for display in the main lobby of our hotel with each cha
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