Ibrutinib Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Data Published in The New England Journal of Medicine

   Ibrutinib Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Data
               Published in The New England Journal of Medicine

A second study in relapsed/refractory mantle cell lymphoma (MCL) also
published in the online edition

PR Newswire

RARITAN, N.J., June 19, 2013

RARITAN, N.J., June 19, 2013 /PRNewswire/ -- Janssen Research & Development,
LLC (Janssen) today announced The New England Journal of Medicine (NEJM) has
published data online about the investigational oral Bruton's Tyrosine Kinase
(BTK) inhibitor ibrutinib as a monotherapy in patients with chronic
lymphocytic leukemia (CLL). Results from a Phase 1b/2 study show that
ibrutinib is well tolerated and produced durable responses at both dose levels
studied in patients with relapsed/refractory CLL or small lymphocytic lymphoma
(SLL). Promising results were seen in patients with advanced disease and in
patients with high risk disease as defined by clinical or genetic features,
such as deletion of part of chromosome 17 (del17p).

A separate study was published in the same online edition, examining the
safety and efficacy of ibrutinib for the treatment of relapsed/refractory
mantle cell lymphoma (MCL). Ibrutinib is being jointly developed by Janssen
and Pharmacyclics, Inc. who also sponsored the studies.

"In the ibrutinib study reported, we continue to observe very promising
results in patients with chronic lymphocytic leukemia," said lead author John
C. Byrd, M.D., Director, Division of Hematology, and D Warren Brown Professor
of Leukemia Research, The Ohio State University, Comprehensive Cancer Center.
"The high rate of durable remissions achieved with ibrutinib as a single-agent
in relapsed or refractory patients and those at high risk historically appears
better than any other single agent tested in CLL."

A subanalysis of the Phase 1b/2 open-label study included 85 patients with
relapsed/refractory CLL or SLL, most of whom had advanced disease and were
treated with several rounds of different therapies prior to their enrollment.
In the study, 35% of patients had del17p. Patients with this chromosomal
deletion generally respond poorly to chemotherapy, the current standard of
treatment for CLL.

Patients received 420 mg (n=51) or 840 mg (n=34) of ibrutinib monotherapy
orally, once daily. Overall response rates were 71% for patients in each
treatment arm (dose group). Study patients with del17p had an overall response
rate of 68%. After an estimated median follow-up period of 26 months, 75% of
patients were progression free and 83% of patients were still alive.

                                                             High risk del17p
                                   420mg (n=51) 840mg (n=34) within both
                                                             dosing
                                                             arms (n=29)
Overall response (%)               71%          71%          68%
Complete response
                                   2            0            1
(# of patients)
Partial response (# of patients)   34           24           N/A
Estimated Overall survival         83%
(%) at 26 months follow up
Estimated Progression-free
survival                           75%
(%) at 26 months follow up

"Among patients with CLL, those with del17p have a particularly poor
prognosis. There is a need for new treatment options as the current standard
therapy for these patients is inadequate. Recently, ibrutinib was granted a
third Breakthrough Therapy Designation by the U.S. FDA for this reason," said
Peter F. Lebowitz, M.D., Ph.D., Global Oncology Therapeutic Area Head,
Janssen. "These data provide important insights into the safety and durability
of response of ibrutinib in patients with relapsed and high-risk CLL and SLL."

Most adverse events (AEs) were Grade 1 or 2 in severity, with the most common
being diarrhea (47%), infections (33%) and fatigue (28%). Two patients (4%)
treated with ibrutinib 420 mg/day and four patients (12%) treated with
ibrutinib 840 mg/day experienced an AE leading to treatment discontinuation.
The most common grade 3 or greater AEs in both ibrutinib treatment arms were
pneumonia (12%) and dehydration (6%), despite the immunocompromised condition
of these heavily pretreated patients. Grade 3-4 hematological toxicities were
infrequent, with anemia (6%), neutropenia (19%) and thrombocytopenia (6%) as
the leading AEs. There was no evidence of cumulative toxicity or long-term
safety concerns.

Study Design

The Phase 1b/2, open-label, multicenter study was designed to determine the
safety, efficacy, pharmacokinetics and pharmacodynamics of ibrutinib in
patients with relapsed/refractory CLL. The primary objective of the study was
to determine the safety of the two fixed-dose regimens of ibrutinib, assessed
by evaluating the frequency and severity of AEs. Secondary efficacy endpoints
included: overall response rate, progression-free survival and overall
survival. The data were presented in part at the annual meeting of the
American Society of Hematology in December 2012.

The study enrolled patients with a confirmed diagnosis of relapsed/refractory
CLL or SLL (a disease that mirrors the symptoms and progression of CLL) at
eight sites in the U.S. Patients who participated in the study had a median of
four prior therapies and 65% of the patients had advanced disease. Thirty-five
percent of CLL patients had del17p, a genetic mutation associated with a poor
prognosis.

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
CLL is a slow-growing cancer of the white blood cells (lymphocytes), most
commonly B-cells. CLL is the most common adult leukemia.[1] The genetic
mutation 17p occurs when part of chromosome 17 has been lost. CLL patients
with 17p deletion have poor treatment outcomes.[2] 17p deletion is reported in
7% of CLL cases,[3] with approximately 20 to 40% of relapsed/refractory
patients harboring the mutation.[4] SLL is a slow-growing lymphoma in which
too many immature white blood cells cause lymph nodes to become larger than
normal.[5]

About Ibrutinib
Ibrutinib is an investigational, oral Bruton's tyrosine kinase (BTK)
inhibitor. The effectiveness and safety of ibrutinib alone or in combination
with other treatments is being studied in several B-cell malignancies.

Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license
agreement in December 2011 to co-develop and co-commercialize ibrutinib. The
regulatory filing for ibrutinib in MCL is expected to be made prior to the end
of the third quarter of 2013. Details about the complete ibrutinib clinical
program is posted on clinicaltrials.gov.

To date, ibrutinib has been granted three Breakthrough Therapy Designations by
the U.S. Food & Drug Administration (FDA) as a monotherapy for the treatment
of patients with CLL or SLL with del17p; patients with relapsed/refractory MCL
who have received prior therapy, and in patients with Waldenstrom's
macroglobulinemia (WM). The implications of Breakthrough Therapy Designation
cannot be determined at this time.

About Janssen Research & Development

At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Driven by our commitment to patients, we develop
innovative products, services and healthcare solutions to help people
throughout the world. Janssen Research & Development and Janssen Biotech are
part of the Janssen Pharmaceutical Companies. Please visit
http://www.janssenrnd.com for more information.

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[1] How Common is CLL? Leukemia & Lymphoma Society.
http://www.lls.org/#/diseaseinformation/leukemia/chroniclymphocyticleukemia/incidence/.
Accessed March 2013.

[2]Non-Hodgkin's Lymphomas. Version 1.2013. NCCN Clinical Practice Guidelines
in Oncology. http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf.
Accessed March 2013.

[3]Non-Hodgkin's Lymphomas. Version 1.2013. NCCN Clinical Practice Guidelines
in Oncology. http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf.
Accessed March 2013.

[4] Stilgenbaueer S and Zenz T. Understanding and Managing Ultra High-Risk
Chronic Lymphocytic Leukemia. Hematology. 2010: 481-488.

[5] Small Lymphocytic Lymphoma. National Cancer Institute.
http://www.cancer.gov/dictionary?cdrid=407751. Accessed March 2013.

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SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com/
 
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