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06 December 2015
BEERSE, Belgium--(BUSINESS WIRE)--Data from the investigational, randomised, multi-centre, open-label
Phase 3 RESONATETM-2 (PCYC-1115) trial show ibrutinib
(IMBRUVICA®) was superior to chlorambucil in all efficacy
endpoints measured in patients with treatment-na"ive chronic lymphocytic
leukaemia or small lymphocytic lymphoma (CLL/SLL) aged 65 or older,
Janssen-Cilag International NV announced today. Kamagra (Sildenafil Citrate) without prescription Ibrutinib significantly
prolonged progression-free survival (PFS), the study’s primary endpoint,
and overall survival (OS), a key secondary endpoint, and also improved
other haematologic measures. Buy Neggram (Nalidixic Acid) with no prescription Notably, ibrutinib was associated with a 98
percent OS rate versus 85 percent for chlorambucil at 24 months. Proventil (Albuterol) without prescription These
data will be included in a presentation today during the official press
programme at the 2015 American Society of Hematology (ASH) meeting in
Orlando, FL, U.S. Buy Infiniair with free prescription and simultaneously published in The New England
Journal of Medicine.1 IMBRUVICA is co-developed by Cilag
GmbH International, a member of the Janssen Pharmaceutical Companies,
and Pharmacyclics LLC, an AbbVie company. Caverta (Sildenafil Citrate) with no prescription Janssen affiliates market
IMBRUVICA in EMEA (Europe, Middle East and Africa) as well as the rest
of the world, except for the United States, where Janssen Biotech, Inc. Buy Histidine online
and Pharmacyclics LLC co-market it.
These data will be presented in full by RESONATE-2 study investigator
Alessandra Tedeschi, M.D., Medical Director, Azienda Ospedaliera
Niguarda Ca Granda, Milan, Italy, during the “CLL: Therapy, Excluding
Transplantation: Upfront CLL Therapy Excluding Transplantation” session
on Monday, December 7, at 7:30am Eastern Time (ET) / 1.30pm Central
European Time (CET).
"The RESONATE-2 trial is ground-breaking as the first randomised Phase 3
trial of B-cell receptor antagonist, ibrutinib, in previously untreated
CLL,” said Professor Peter Hillmen, Haematology, St. http://doctor-consult.blogspot.com James’s University
Hospital, Leeds, who is an investigator in the RESONATE-2 clinical
trial. “The results of RESONATE-2 are impressive. The improvement in
progression free survival for ibrutinib in front-line treatment compared
to chlorambucil is statistically significant. The improvement in overall
survival for ibrutinib compared to chlorambucil even with a pre-planned
cross-over to ibrutinib is unexpected. This indicates that the best
outcomes will be achieved with ibrutinib when it is used as the initial
therapy in patients with CLL."
The Independent Review Committee (IRC) found ibrutinib significantly
prolonged PFS compared with chlorambucil. The hazard ratio (HR) was 0.16
(95 percent CI, 0.09-0.28; P<0.001), which represents a reduction in the
risk of progression or death by 84 percent versus chlorambucil (median
not reached vs. 18.9 months); the PFS rate at 18 months was 90 percent
for ibrutinib versus 52 percent for chlorambucil. Ibrutinib also
significantly prolonged OS (HR=0.16: 95 percent CI, 0.05, 0.56; P=0.001)
with a 24-month survival rate of 98 percent, compared to 85 percent for
patients in the chlorambucil arm. Additionally, ibrutinib was associated
with a significantly higher ORR (86 percent vs. 35 percent; P<0.001) as
assessed by the IRC and significantly increased the rate of sustained
improvements in both haemoglobin and platelets.1
“RESONATE-2 is the first Phase 3 head-to-head trial to evaluate the
efficacy and safety of ibrutinib monotherapy versus traditional
chemotherapy in patients with treatment-na"ive CLL. The strength of these
data may very well represent a turning point in the treatment of CLL/SLL
and change when it may be appropriate to treat these patients with
ibrutinib,” said Jane Griffiths, Company Group Chairman, Janssen Europe,
Middle East and Africa. “We continue to see positive results with
ibrutinib, and it is particularly exciting to see the extent of new data
at ASH, demonstrating our commitment to exploring ibrutinib use for
those who could most benefit from it, and our growing haematology
offering.”
The safety of ibrutinib in this patient population was consistent with
previously reported studies. It is worth noting that exposure to
treatment and adverse event (AE) follow-up was nearly 2.5 times longer
for ibrutinib compared with chlorambucil and 87 percent of patients
randomised to ibrutinib were still on therapy at the time of analysis.
Overall, AEs leading to treatment discontinuation were less frequent
with ibrutinib than with chlorambucil (nine percent vs. 23 percent,
respectively). The most common AEs (>=20 percent) of any Grade in the
RESONATE-2 trial for ibrutinib were diarrhoea (42 percent), fatigue (30
percent), cough (22 percent) and nausea (22 percent); AEs for
chlorambucil included nausea (39 percent), fatigue (38 percent),
neutropenia (23 percent) and vomiting (20 percent). Hypertension
occurred at a higher rate in the ibrutinib arm (14 percent; Grade 3 in
four percent, no Grade 4 or 5). All six patients with Grade 3
hypertension were managed with hypertensive medication and did not
require ibrutinib dose reduction or discontinuation. Four ibrutinib
patients experienced Grade 3 haemorrhage and one experienced Grade 4
haemorrhage.1 Atrial fibrillation occurred in
eight patients (six percent) in the ibrutinib arm and was primarily
Grade 2 in six patients and Grade 3 in two patients. It was managed with
discontinuation in two patients and without a dose modification in
remaining patients.
There were three deaths in the ibrutinib arm and 17 deaths on the
chlorambucil arm over the median follow-up of 18.4 months. None of the
patients who progressed on the ibrutinib arm died during the subsequent
follow-up period.1
RESONATE-2 is a Pharmacyclics-sponsored trial and is the second Phase 3
study demonstrating a significant benefit of ibrutinib vs. a comparator.2,3
The trial enrolled 269 patients with CLL/SLL aged 65 years or older
without prior treatment in the U.S., EU and other regions. CLL patients
with deletion of the short arm of chromosome 17 (del 17p CLL) were
excluded from the trial as single-agent chlorambucil is not recognised
as an appropriate therapy in this patient population. Patients were
randomised to receive either ibrutinib 420 mg orally, once daily until
progression or toxicity or chlorambucil 0.5 to 0.8 mg/kg on days one and
15 of each 28-day cycle for up to 12 cycles. The primary endpoint of the
study was PFS as assessed by an IRC according to the International
Workshop on Chronic Lymphocytic Leukaemia (iWCLL) 2008 criteria, with
modification for treatment-related lymphocytosis. Key secondary
endpoints included ORR, OS, rate of haematologic improvement and safety.1
The RESONATE-2 results are the basis for a Type II variation application
to the European Medicines Agency (EMA), seeking to broaden the existing
marketing authorisation for IMBRUVICA to include previously untreated
patients with CLL, which was which was announced on November
3, 2015. More information about the study can be found on .clinicaltrials.gov.
About IMBRUVICA® (ibrutinib)
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.4
By blocking this BTK protein, ibrutinib helps kill and reduce the number
of cancer cells. It also slows down the worsening of the cancer.5
Ibrutinib is approved in Europe for the treatment of adult patients with
relapsed or refractory mantle cell lymphoma (MCL), or adult patients
with chronic lymphocytic leukaemia (CLL) who have received at least one
prior therapy, or in first line patients with CLL in the presence of 17p
deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy;6
it is also approved for adult patients with Waldenstr"om’s
macroglobulinemia (WM) who have received at least one prior therapy, or
in first line treatment for patients unsuitable for chemo-immunotherapy;6
regulatory approval for additional uses has not yet been
granted. Investigational uses for ibrutinib, alone and in combination
with other treatments, are under way in several blood cancers including
CLL, MCL, WM, diffuse large B-cell lymphoma (DLBCL), follicular lymphoma
(FL), multiple myeloma (MM) and marginal zone lymphoma (MZL).
Ibrutinib is co-developed by Cilag GmbH International, a member of the
Janssen Pharmaceutical Companies, and Pharmacyclics LLC, an AbbVie
company. Janssen affiliates market ibrutinib in EMEA (Europe, Middle
East and Africa) as well as the rest of the world, except for the United
States, where Janssen Biotech, Inc. and Pharmacyclics LLC co-market it.
Janssen and Pharmacyclics are continuing an extensive clinical
development programme for ibrutinib, including Phase 3 study commitments
in multiple patient populations – please see the IMBRUVICA
summary of product characteristics for further information.
About CLL
In most patients, CLL is generally a slow-growing blood cancer of the
white blood cells called B-lymphocytes.7 The median age at
diagnosis is 72 years,8 and incidence rates among men and
women in Europe are approximately 5.87 and 4.01 cases per 100,000
persons per year, respectively.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.
CLL cells are found in both the lymphatic system and the blood.11
When the cancer cells are located mostly in the lymph nodes, the disease
is called small lymphocytic lymphoma (SLL). Both CLL and SLL are
considered different manifestations of the same entity, as classified in
the fourth edition of the World Health Organization Classification of
Tumours of Haematopoietic and Lymphoid Tissues.12
Janssen in Oncology
Our goal is to fundamentally alter the way cancer is understood,
diagnosed, and managed, reinforcing our commitment to the patients who
inspire us. In looking to find innovative ways to address the cancer
challenge, our primary efforts focus on several treatment and prevention
solutions. These include a focus on haematologic malignancies, prostate
cancer and lung cancer; cancer interception with the goal of developing
products that interrupt the carcinogenic process; biomarkers that may
help guide targeted, individualised use of our therapies; as well as
safe and effective identification and treatment of early changes in the
tumour microenvironment.
About Janssen
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to
addressing and solving the most important unmet medical needs of our
time, including oncology (e.g., multiple myeloma and prostate cancer),
immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia,
dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and
tuberculosis), and cardiovascular and metabolic diseases (e.g.,
diabetes). Driven by our commitment to patients, we develop sustainable,
integrated healthcare solutions by working side-by-side with healthcare
stakeholders, based on partnerships of trust and transparency. More
information can be found on .janssen-emea.com.
Follow us on .twitter.com/janssenEMEA
for our latest news.
Cautions Concerning Forward-Looking
Statements
This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
product 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 any of the Janssen Pharmaceutical Companies and/or
Johnson & Johnson. Risks and uncertainties include, but are not limited
to: challenges and uncertainties inherent in new product development,
including obtaining regulatory approvals; uncertainty of commercial
success; 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 or financial distress of
purchasers of health care products and services; changes to applicable
laws and regulations, including global health care reforms;
manufacturing difficulties and delays; and trends toward health care
cost containment. A further list and description 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 28, 2014,
including in Exhibit 99 thereto, and the company s subsequent filings
with the Securities and Exchange Commission. Copies of these filings are
available online at .sec.gov,
.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertake to update any forward-looking
statement as a result of new information or future events or
developments.
References
1. Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib vs
chlorambucil in treatment-na"ive chronic lymphocytic leukemia. N Engl
J Med. 2015:1-8.
2. 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.
3. Brown JR, Hillmen P, O’Brien S, et al. Updated efficacy
including genetic and clinical subgroup analysis and overall safety in
the phase 3 RESONATE™ trial of ibrutinib versus ofatumumab in previously
treated chronic lymphocytic leukemia/small lymphocytic lymphoma. Blood.
2014;124(21):abstract 3331.
4. 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.
5. European Medicines Agency. How is the medicine expected to work? .ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2012/06/human_orphan_001058.jsp&mid=WC0b01ac058001d12b
Last accessed November 2015.
6. Imbruvica Summary of Product Characteristics, October 2015. Available
at: .ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdf
Last accessed November 2015.
7. American Cancer Society. What is chronic lymphocytic leukemia?
Available at: .cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-what-is-cll
Last accessed November 2015.
8. Eichhorst B, Dreyling M, Robak T, Montserrat E, Hallek M; ESMO
Guidelines Working Group. Chronic lymphocytic leukemia: ESMO Clinical
Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol
2011;22(Suppl.6):vi50-vi54.
9. 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.
10. Sagatys EM, Zhang L. Clinical and laboratory prognostic indicators
in chronic lymphocytic leukemia. Cancer Control
2012;19:18-25.Stilgenbauer S, Zenz T. Understanding and Managing Ultra
High-Risk Chronic Lymphocytic Leukemia. Hematology. 2010;481-8.
11. Hallek M. Signaling the end of chronic lymphocytic leukemia: new
frontline. Blood. 2013;122:3723-34.
12. Santos FP, O’Brien S. Small lymphocytic lymphoma and chronic
lymphocytic leukemia are they the same disease? Cancer J.
2012;8:396-403.
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