VELCADE® Data at EHA 2014 Highlight Efficacy in Newly-Diagnosed Mantle Cell Lymphoma and Reinforce Its Role as a Backbone of

  VELCADE® Data at EHA 2014 Highlight Efficacy in Newly-Diagnosed Mantle Cell
  Lymphoma and Reinforce Its Role as a Backbone of Multiple Myeloma Therapy

Note: This press release corresponds to EHA abstracts S1345 and P958

European Hematology Association Congress 2014

Business Wire

BEERSE, Belgium -- June 15, 2014

Janssen-Cilag International NV today announced Phase III study data
demonstrating that the investigational use of a VELCADE® (bortezomib)-based
combination in the treatment of patients with Mantle Cell Lymphoma (MCL) who
were newly-diagnosed and unsuitable, or not considered, for a stem-cell
transplant, resulted in a significant increase in progression-free survival
(PFS) versus standard of care.^1 The increase in PFS seen was 96 percent as
assessed by investigators and 56 percent as assessed by an independent review
committee.^1 These data have been presented as part of the official programme
of events at the 19^th Annual Congress of the European Hematology Association
(EHA), taking place on 12-15 June, 2014 in Milan, Italy.

In addition to the VELCADE® (bortezomib)-based data in the treatment of
patients with MCL, studies on VELCADE in Multiple Myeloma (MM) have continued
to reinforce its position as a backbone of therapy. As part of a study looking
at the benefits of subcutaneous (under the skin) vs. intravenous (direct into
the vein) administration of VELCADE in patients with relapsed MM,
investigators reported on a subgroup of patients with renal function
impairment. Data looked at overall response rates, speed of response and the
likelihood of patients who had received subcutaneous VELCADE to reverse their
renal impairment.^2

Data on VELCADE-based combination therapy in Mantle Cell Lymphoma (abstract

Analysis of the randomised, open-label, active-controlled, multicentre,
international prospective Phase III LYM-3002 study, reported on 15 June, 2014,
highlighted that, compared to the treatment combination R-CHOP^1, the
VELCADE-based regimen, VR-CAP^2 increased progression-free survival (PFS) (the
time patients live without their disease progressing) by 96 percent (30.7 vs.
16.1 months; HR 0.51; p<0.001) in previously-untreated patients with MCL, as
assessed by investigators. Analysis performed by an independent review
committee (IRC) also found a significant, 56 percent increase in PFS (24.7 vs.
14.4 months; HR 0.63; p<0.001).^1

“Mantle Cell Lymphoma is an aggressive blood cancer and treatment options for
newly diagnosed patients are limited,” said Tadeusz Robak, Professor of
Hematology at the Medical University of Lodz, Poland and principal
investigator on the trial. “This study clearly demonstrates a range of
potential benefits in using a bortezomib-based frontline therapy in those
patients. It is encouraging that a relatively short treatment duration with
the bortezomib-based regimen results in a longer time until the next
chemotherapy is needed.”

The study includes 487 patients with newly-diagnosed MCL who were ineligible,
or not considered, for bone marrow transplantation. Its objective is to
compare the efficacy and safety of the combination of VR-CAP with a current
standard of care in frontline MCL, R-CHOP. The primary endpoint is
progression-free survival. At a median follow-up of 40 months, median PFS was
30.7 months (VR-CAP) vs. 16.1 months (R-CHOP) (HR=0.51, P<0.001) as assessed
by investigators. Analysis performed by an independent review committee also
found a significant, 56 percent increase in PFS (24.7 vs. 14.4 months; HR
0.63; p<0.001). Median overall survival (OS), a key secondary endpoint, had
not been reached for patients who received VR-CAP, although a median OS of 56
months was observed in patients treated with R-CHOP (HR 0.80; P=0.17). Though
not a pre-specified endpoint, the four-year survival rate showed a trend
towards prolonged survival with VR-CAP. At four years, survival was reported
as 64.4 percent in the experimental arm vs. 53.9 percent in the control arm.^1
The overall response rate (ORR) was 92 percent in the VR-CAP arm compared to
90 percent in the control arm (OR=1.4; P=0.275]. The complete response rate
(CR+CRu) was 53 percent in the VR-CAP arm compared to 42 percent in the
control arm (OR=1.7; P=0.007].^1

Overall, among patients receiving VR-CAP compared to R-CHOP, serious adverse
events (AE) were reported in 38 percent vs. 30 percent of patients and grade
≥3 AEs were reported in 93 percent vs. 85 percent. Discontinuations of
treatment due to AEs were nine percent (VR-CAP) vs. seven percent (R-CHOP) and
on-treatment drug-related deaths were two percent vs. three percent.^1

Other secondary endpoint results for patients receiving VR-CAP vs. R-CHOP

  *30.5 vs. 16.1 months median time to progression (HR 0.58; P<0.001)
  *44.5 vs. 24.8 months median time to subsequent anti-lymphoma treatment (HR
    0.50; P<0.001)
  *40.6 vs. 20.5 months median treatment-free interval (HR 0.50; P<0.001)

Subcutaneous (under the skin) vs. intravenous (direct to vein) administration
of VELCADE (abstract P958)

Results of a sub-analysis of the pivotal MMY-3021 study, reported on 14 June
2014, showed that subcutaneous (SC) administration of VELCADE in patients with
Multiple Myeloma (MM) who had renal impairment appeared to provide a more
rapid time-to-response (TTR) and higher response rates (ORR) than with
intravenous (IV) administration. This was accompanied by higher rates of renal
impairment reversal.^2

In MM patients with moderate-to-severe renal impairment:^2

  *The overall response rate (ORR) was 53 percent in the SC arm and 31% in
    the IV arm (RR 1.73, CR 6% vs. 0%).
  *Median TTR was 2.3 months for SC patients and 3.3 months in IV patients
    (HR 1.205).
  *Renal impairment was reversed in 30 percent (10/33) of SC patients vs. 15
    percent (2/13) of those treated with IV.
  *Grade ≥ 3 adverse events were seen in 70 percent of SC patients vs. 77
    percent of patients on IV.

                                   # ENDS #


About VELCADE (bortezomib)^3

VELCADE (bortezomib) is a medicine currently licensed in the EU to treat the
blood-based cancer, Multiple Myeloma. It contains an active substance called
bortezomib and is the first in a specific class of medicines known as
proteasome inhibitors. Proteasomes are present in all cells and play an
important role in controlling cell function, growth and also how cells
interact with the other cells around them. Bortezomib reversibly interrupts
the normal working of cell proteasomes causing myeloma cancer cells to stop
growing and die.

VELCADE has a predictable safety profile and a favourable benefit–risk ratio.
The most common side effects reported with VELCADE (bortezomib) ^ include
fatigue, gastrointestinal adverse events, transient thrombocytopenia and

VELCADE is the market leader in the treatment of frontline non-transplant
eligible Multiple Myeloma. It is co-developed by Millennium: the Takeda
oncology company and Janssen Pharmaceutical Companies. Millennium: the Takeda
oncology company is responsible for commercialisation of VELCADE in the U.S.;
Janssen Pharmaceutical Companies are responsible for commercialisation in
Europe and the rest of the world. Takeda Pharmaceutical Company Limited and
Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved
in more than 90 countries and has been used to treat more than 550,000
patients worldwide.

VELCADE (bortezomib) in Mantle Cell Lymphoma

In Europe, VELCADE is not currently licensed to treat Mantle Cell Lymphoma
(MCL). VELCADE’s approved indications can be viewed online at:^3

In 2006, the United States approved VELCADE for the treatment of patients with
MCL who have received at least one prior therapy. VELCADE has subsequently
been approved for the treatment of relapsed MCL in 53 additional countries,
including Canada and Switzerland.

About Mantle Cell Lymphoma

MCL is a rare and aggressive blood cancer that usually occurs in older adults,
with the median age at diagnosis being 65 years. The disease typically begins
in the lymph nodes, but can spread to other tissues such as bone marrow, liver
and spleen. The incidence rates among men and women in Europe are
approximately 0.64 and 0.27 cases per 100,000 persons per year, respectively.
MCL patients generally have a poor prognosis. Median overall survival is
typically three to four years, and only one to two years in patients following
the first relapse.^4,5,6,7

About Multiple Myeloma

Multiple Myeloma is an incurable blood cancer that starts in the bone marrow
and is characterised by an excess proliferation of abnormal plasma cells.^8 It
is the second most frequent form of malignant bone marrow diseases and is a
relatively rare form of cancer that accounts for roughly one percent of all
cancers and roughly two percent of all deaths from cancer.  In Europe, around
60,000 people are living with the disease and there are 21,420 new cases and
15,000 deaths every year.^9

About Janssen

Janssen-Cilag International NV is one of the Janssen Pharmaceutical Companies.
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 Follow us on for our latest

Janssen in Oncology

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 disease area strongholds that focus on hematologic malignancies and
prostate 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.

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 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 inherent in new
product development, including obtaining regulatory approvals; competition,
including technological advances, new products and patents attained by
competitors; 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; general industry conditions including 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 Johnson & Johnson’s Annual
Report on Form 10-K for the fiscal year ended December 29, 2013, including in
Exhibit 99 thereto, and subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at, or on request from Johnson & Johnson. None of the Janssen
Pharmaceutical Companies or Johnson & Johnson undertakes to update any
forward-looking statements as a result of new information or future events or



1 – Robak et al. Phase 3 data investigating VR-CAP (VELCADE IV in combination
with rituximab, cyclophosphamide, doxorubicin, and prednisone) vs. R-CHOP
(rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) as
frontline treatment of patients with Mantle Cell Lymphoma show significant
increases in progression-free survival and a number of secondary endpoints in
favor of the VELCADE-based treatment arm. abstract S1345

2 – Moreau et al. Sub-analysis of pivotal Phase 3 MMY-3021 study looking at
efficacy and safety of subcutaneous (under the skin) vs. intravenous (direct
to vein) administration of VELCADE highlights benefits in patients with renal
impairment. EHA 2014, abstract P958.

3 – VELCADE Summary of Product Characteristics. Available at
(accessed June 2014).

4 – McKay P, Leach M, Jackson R, et al. Guidelines for the investigation and
management of Mantle Cell Lymphoma. Br J Haematol 2012;159:405-26.

5 – Leukemia and Lymphoma Society. Mantle Cell Lymphoma Facts. Available at
(accessed June 2014).

6 – Smedby KE, Hjalgrim H. Epidemiology and etiology of Mantle Cell Lymphoma
and other non-Hodgkin lymphoma subtypes. Semin Cancer Biol 2011;21:293-8.

7 – Goy A, Bernstein SH, Kahl BS, et al. Bortezomib in patients with relapsed
or refractory Mantle Cell Lymphoma: updated time-to-event analyses of the
multicenter phase 2 PINNACLE study. Ann Oncol 2009;20:520-5.

8 – Myeloma Patients Europe. What is Myeloma? Available at (accessed June

9 - Myeloma Patients Europe. FAQ’s. Available at (accessed June 2014).


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