Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at

  Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in
  Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of
                          Hematology Annual Meeting

Data Show Overall Response of 68 Percent in Patients with Relapsed or
Refractory Disease

PR Newswire

ATLANTA, Dec. 11, 2012

ATLANTA, Dec. 11, 2012 /PRNewswire/ --Janssen Research & Development, LLC,
today announced follow-up findings from an ongoing, open-label, Phase 2,
single-agent study showing that in patients with relapsed or refractory mantle
cell lymphoma (MCL), the investigational oral agent ibrutinib (PCI-32765)
resulted in an overall response rate (ORR) of 68 percent, including a complete
response (CR) of 22 percent and a partial response (PR) of 46 percent. The
study included both bortezomib-naive and bortezomib-exposed patients; 111
received ibrutinib and 110 were evaluable for efficacy. Median follow-up time
was 9.2 months, with a range of time to response to treatment of 1.4 to 16.4

The results were presented by lead investigator Michael L. Wang, M.D.,
associate professor in the Department of Lymphoma and Myeloma at The
University of Texas MD Anderson Cancer Center, at the 54th Annual Meeting of
theAmerican Society of Hematology(ASH) in Atlanta, GA. The findings extend
the preliminary results reported by the investigators last year at ASH, which
showed a similar ORR of 69 percent, including a CR of 16 percent and PR of 53
percent. Results were similar between the bortezomib-naive and
bortezomib-exposed patients.

"With continued follow up, the overall response rate is similar to what we've
reported before. In addition, the compound has presented a tolerable safety
profile," said Dr. Wang. "The data build on our knowledge and support the
continued study of ibrutinib to determine its potential role as a treatment
option for patients with relapsed or refractory MCL, a population that is
currently difficult to treat."

Relapsed MCL means the disease has returned after an initial partial or total
remission. Refractory MCL refers to cancer that does not respond to current

Among the study's secondary endpoints, the median progression-free survival
(PFS) with ibrutinib was 13.9 months. Additionally, the median time to
response to treatment with ibrutinib was 1.9 months for first PR (range of 1.4
to 9.1 months) and 5.5 months for first CR (range of 1.7 to 16.4 months).

Safety data were available for 111 patients in the trial. Patients treated
with ibrutinib experienced treatment-emergent adverse events (AEs) that were
consistent with previously reported data. Treatment-emergent AEs were mainly
grade 1 or 2. Treatment-emergent AEs of all grades occurring in 20 percent or
more patients were diarrhea, fatigue, nausea, upper respiratory tract
infection and dyspnea (shortness of breath). Pneumonia was the only grade 3 or
higher treatment-emergent AE occurring in 5 percent or more patients.

"We are encouraged by the rate and durability of response and the tolerability
profile suggested in these Phase 2 study follow-up findings, and look forward
to enrolling and seeing results from additional Phase 2 and Phase 3 trials,"
said Peter Lebowitz, M.D., Ph.D., Global Oncology Therapeutic Area Head,
Janssen. "Our collaboration with Pharmacyclics to co-develop ibrutinib in a
broad range of B-cell malignancies is part of Janssen's longstanding
commitment to apply innovative science to address the most critical unmet

Study Details

PCYC-1104-CA is an international, multicenter, open-label, Phase 2,
single-agent study that treated 111 patients (63 bortezomib-naive patients and
48 bortezomib-exposed patients) with relapsed or refractory MCL. Patients were
treated with oral ibrutinib 560 mg daily for continuous 28-day cycles until
disease progression. The primary endpoint of the study is ORR, and secondary
endpoints include duration of response (DOR), PFS, overall survival (OS) and
safety/tolerability. The study was conducted by Pharmacyclics.

About Mantle Cell Lymphoma

MCL is an aggressive type of B-cell non-Hodgkin lymphoma (NHL) that usually
occurs in middle-aged or older adults. The disease typically begins in the
lymph nodes but can spread to other tissues, such as bone marrow and liver. In
the United States, there are approximately 70,130 new cases of NHL and 4,600
new cases of MCL each year.

About Ibrutinib

Ibrutinib was designed to specifically target and selectively inhibit an
enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at
least three critical B-cell pro-survival mechanisms occurring in parallel –
regulating B-cell apoptosis, cell adhesion, and lymphocyte migration and
homing. Through these multiple actions, BTK helps to direct malignant B cells
to lymphoid tissues, thus allowing access to a microenvironment necessary for

The effectiveness of ibrutinib alone or in combination with other treatments
is being studied in several B-cell malignancies, including chronic lymphocytic
leukemia/small lymphocytic lymphoma, relapsed/refractory mantle cell lymphoma,
diffuse large B-cell lymphoma, follicular lymphoma and multiple myeloma. The
clinical development program includes 23 clinical trials – six Phase 3, nine
Phase 2, one Phase 1/2, and seven Phase 1 trials currently underway.

About the Janssen and Pharmacyclics Collaboration

Janssen Biotech, Inc. and Pharmacyclics Inc. entered into a worldwide
collaboration on December 8, 2011, to develop and commercialize ibrutinib.
Following regulatory approval, Janssen and Pharmacyclics will co-commercialize
ibrutinib. In the United States, both companies will share in
commercialization activities; outside the United States, Janssen will lead and
perform commercialization activities. Each company is leading development for
specific indications.

About Janssen Research & Development, LLC

Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has
affiliated facilities in Europe, the United States and Asia. Janssen Research
& Development is leveraging a combination of internal and external innovation
to discover and develop novel medicines and solutions in five distinct
therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and
Vaccines, and Cardiovascular and Metabolism. For more information about
Janssen Research & Development, LLC visit

Janssen Research & Development is part of the Janssen Pharmaceutical Companies
of Johnson & Johnson. Driven by our commitment to patients, we work together
to bring innovative ideas, products, services and solutions to address serious
unmet medical needs around the world.

About Janssen Biotech, Inc.

Janssen Biotech, Inc. redefines the standard of care in immunology, oncology,
urology and nephrology. Built upon a rich legacy of innovative firsts,
Janssen Biotech has delivered on the promise of new treatments and ways to
improve the health of individuals with serious disease. Beyond its innovative
medicines, Janssen Biotech is at the forefront of developing education and
public policy initiatives to ensure patients and their families, caregivers,
advocates and health care professionals have access to the latest treatment
information, support services and quality care. For more information on
Janssen Biotech, Inc. or its products, visit

Janssen Biotech, Inc. is one of the Janssen Pharmaceutical Companies of
Johnson & Johnson, 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 work together to bring innovative
ideas, products, services and solutions to people throughout the world.
Follow us on Twitter at

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. 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 unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Janssen Research &
Development, LLC and/or Johnson & Johnson. Risks and uncertainties include,
but are not limited to, general industry conditions and competition; economic
factors, such as interest rate and currency exchange rate fluctuations;
technological advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining regulatory
approvals; challenges to patents; changes in behavior and spending patterns or
financial distress of purchasers of health care products and services; changes
to governmental laws and regulations and domestic and foreign health care
reforms; trends toward health care cost containment; and increased scrutiny of
the health care industry by government agencies. A further list and
description of these risks, uncertainties and other factors can be found in
Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal
year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent
filings, are available online at, or on request from
Johnson & Johnson. Neither Janssen Research & Development, LLC nor Johnson &
Johnson undertake to update any forward-looking statements as a result of new
information or future events or developments.)

Note: Data in this release correspond to ASH Abstract 904.

SOURCE Janssen Research & Development, LLC

Contact: Media: Kellie McLaughlin, +1-908-927-7477 office, +1-609-468-8356
cell; or Investor Relations: Stan Panasewicz, +1-732-524-2524 office, or
Louise Mehrotra, +1-732-524-6491 office; or U.S. Medical Inquiries:
1-800-JANSSEN (800-526-7736)
Press spacebar to pause and continue. Press esc to stop.