Ibrutinib RESONATE(TM) Data Show Significant Improvements in Progression-Free Survival and Overall Survival in Patients with Ch

 Ibrutinib RESONATE(TM) Data Show Significant Improvements in Progression-Free  Survival and Overall Survival in Patients with Chronic Lymphocytic Leukemia or  Small Lymphocytic Lymphoma  Phase 3 data featured in the official press program of the 50(th) annual  meeting of the American Society of Clinical Oncology and simultaneously  published in the New England Journal of Medicine  TORONTO, June 2, 2014 /CNW/ - Data from the international, multicenter Phase 3  RESONATE(TM) trial show single-agent ibrutinib, a targeted therapy,  significantly lengthened progression-free survival (PFS) and overall survival  (OS) in patients with relapsed or refractory chronic lymphocytic leukemia  (CLL) or small lymphocytic lymphoma (SLL).  Janssen Inc. announced today that  these data were presented during the official press program at the American  Society of Clinical Oncology (ASCO) meeting in Chicago, IL and they were  simultaneously published in a special edition of The New England Journal of  Medicine.  The results from the RESONATE(TM) study show ibrutinib significantly improved  PFS (median not reached vs. 8.1 months; HR 0.215, 95% CI, 0.146 to 0.317;  P<0.0001) and OS (HR 0.434; 95% CI, 0.238 to 0.789; P=0.0049) compared to  ofatumumab. The median PFS in the ibrutinib arm was not reached because of a  lower rate of progression events than in the ofatumumab arm. These PFS results  represent a 79 per cent reduction in the risk of disease progression or death  from any cause in patients treated with ibrutinib compared to ofatumumab. The  OS results represent a 57 per cent reduction in the risk of death in patients  receiving ibrutinib compared to ofatumumab. Additionally, the overall response  rate (ORR) was significantly higher in patients taking ibrutinib versus  ofatumumab. Forty-three per cent of ibrutinib patients achieved a partial  response (PR) compared to only four per cent of patients taking ofatumumab  (p<0.0001). Consistent results were seen in CLL/SLL patients with a deletion  in the short arm of chromosome 17 (del 17p), a genetic mutation typically  associated with poor prognosis.(1)  "The RESONATE data are particularly exciting for clinicians in Canada as they  show a significant improvement in progression-free and overall survival in  patients with relapsed or refractory CLL compared with our current  treatments," said Dr. Cynthia Toze, Member, Leukemia/BMT Program of British  Columbia, Clinical Professor of Medicine, UBC. "The results demonstrate that  ibrutinib, as a targeted therapy, is an effective and tolerable treatment  option for patients with CLL who have relapsed or whose disease did not  respond to first-line treatment.  Moreover, this drug has shown effectiveness  in the poor risk population of patients with CLL who have deletion 11q or 17p,  comprising over 60 per cent of patients in the RESONATE trial."*  About RESONATE(TM)  RESONATE(TM) is a Phase 3, multi-center, international, open-label, randomized  study that examined ibrutinib versus ofatumumab in relapsed or refractory  patients with CLL/SLL who had received at least one prior therapy and were not  considered appropriate candidates for treatment with purine analog-based  therapy (n=391). Patients were administered either 420 mg oral ibrutinib  (n=195) 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; dose and schedule consistent with local labeling).  Progression-free survival is the primary endpoint of the RESONATE(TM) study,  with OS, ORR and safety as key secondary endpoints. The median follow-up was  9.4 months.  In January 2014, RESONATE(TM) was stopped early at the unanimous  recommendation of an Independent Data Monitoring Committee (IDMC) based on a  planned interim analysis which concluded that the study showed a significant  difference in PFS as compared to the control (the primary endpoint of the  study). The IDMC recommended that the sponsor provide access to ibrutinib to  patients in the ofatumumab arm.  The most common Grade 3 or 4 adverse events (AEs) in the RESONATE(TM) trial  (occurring in five per cent or more of patients) were neutropenia (decreased  amount of neutrophils in the blood; 16 per cent in the ibrutinib arm vs. 14  per cent in the ofatumumab arm), pneumonia (seven per cent vs. five per cent),  thrombocytopenia (decrease in platelets in the blood; six per cent vs. four  per cent) and anemia (five per cent vs. eight per cent). The most commonly  occurring side effects (AEs in 20 per cent or more of patients) were diarrhea  (48 per cent vs.18 per cent), fatigue (28 per cent vs. 30 per cent), pyrexia  (fever; 24 per cent vs. 15 per cent), nausea (26 per cent vs.18 per cent),  anemia (23 per cent vs. 17 per cent) and neutropenia (21 per cent vs. 15 per  cent). Atrial fibrillation of any grade was noted more frequently in patients  receiving ibrutinib (n=10 patients) versus ofatumumab (n=1 patient). Total  treatment exposure was longer for the ibrutinib arm than the ofatumumab arm  (median time: 8.6 months vs. 5.3 months).  Treatment discontinuations due to progressive disease were five per cent in  the ibrutinib arm and 19 per cent in the ofatumumab arm. Four per cent of  patients in both treatment arms (eight patients in the ibrutinib arm and seven  patients in the ofatumumab arm) discontinued treatment due to adverse events  in the clinical trial. Treatment discontinuation due to death occurred in four  per cent of patients in the ibrutinib arm (eight patients) and five per cent  of patients in the ofatumumab arm (nine patients). These events were most  commonly infectious in nature.  About CLL and SLL  Chronic lymphocytic leukemia is a slow-growing blood cancer of white blood  cells called lymphocytes, most commonly B cells.(([1])) Chronic lymphocytic  leukemia is the most common type of leukemia in adults, and is more common in  older adults over 60.[2] In Canada, it is estimated that about 2,400 adults  were diagnosed with CLL in 2010.(2) The disease often eventually progresses;  patients are faced with fewer treatment options and are often prescribed  multiple lines of therapy as they relapse or become resistant to  treatments.(([3]))( )Small lymphocytic leukemia is a slow-growing lymphoma in  which too many immature white blood cells cause lymph nodes to become larger  than normal.(1)  About Ibrutinib  Ibrutinib works by blocking a specific protein called Bruton's tyrosine kinase  (BTK).(4) The BTK protein transmits important signals that tell B cells to  mature and produce antibodies, and is needed by specific cancer cells to  multiply and spread. [4](,[5]) Ibrutinib targets and blocks BTK, inhibiting  the spread and survival of cancer cells.(4)  Ibrutinib received U.S. approval via the FDA's Breakthrough Therapy  Designation and is indicated for the treatment of patients with CLL who have  received at least one prior therapy, and for the treatment of patients with  mantle cell lymphoma (MCL) who have received at least one prior therapy.  Ibrutinib is undergoing priority review at Health Canada in the area of CLL.  Ibrutinib is being jointly developed and commercialized by Janssen Biotech,  Inc. and Pharmacyclics, Inc.  About Janssen Inc.  Janssen Inc. is one of the Janssen Pharmaceutical Companies of Johnson &  Johnson, which are dedicated to addressing and solving some of the most  important unmet medical needs in oncology, immunology, neuroscience,  infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services  and solutions to people throughout the world. Please visit www.janssen.ca for  more information.  * Dr. Cynthia Toze was not compensated for any media work. She has been a paid  consultant to Janssen Inc.  ((___________________________________________))  (1)American Cancer Society. "Leukemia--Chronic Lymphocytic".  http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf.  Accessed April 2014.  (2)The Leukemia and Lymphoma Society of Canada "CLL Incidence",  http://www.llscanada.org/#/diseaseinformation/leukemia/chroniclymphocyticleukem ia/incidence/. Accessed May, 2014.  (3 )Veliz M, Pinilla-Ibarz J. Treatment of relapsed or refractory chronic  lymphocytic leukemia. Cancer Control. 2012 Jan;19(1):37-53.  (4 )IMBRUVICA Prescribing Information, February 2014.  (5 )Genetics Home Reference. Isolated growth hormone deficiency. Available  from: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.  Accessed April 2014.    SOURCE  Janssen Inc.  Media Contact: Kate Hanna, Office: (416) 382-5017; Investor Contact: Stan  Panasewicz, Office: (732) 524-2524; Investor Contact: Louise Mehrotra, Office:  (732) 524-6491  To view this news release in HTML formatting, please use the following URL:  http://www.newswire.ca/en/releases/archive/June2014/02/c2705.html  CO: Janssen Inc. ST: Ontario NI: MTC ECOSURV  
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