VELCADE(R) (bortezomib) Administered Subcutaneously Shows Comparable Response Rates and Safety Profile Compared to Intravenous Administration in the Treatment of Relapsed Multiple Myeloma

By Janssen, PRNE
Sunday, December 5, 2010

Data From Another Study Demonstrating the Efficacy of VELCADE Maintenance Monotherapy and Improvements in Quality of Life Presented at the 52nd American Society of Hematology Annual Meeting

BEERSE, Belgium, December 6, 2010 - Janssen Pharmaceutical Companies today announced the results from data
presented at the 52nd American Society for Hematology (ASH) Annual Meeting in
Orlando, which demonstrated the efficacy, safety and impact on quality of
life of VELCADE(R) (bortezomib) in the treatment of multiple myeloma in
different settings and with different routes of administration.

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The results of a study comparing subcutaneous versus intravenous
administration showed that the efficacy of VELCADE administered
subcutaneously is similar to intravenous administration in patients with
multiple myeloma while some safety advantages were observed.[1]

In this large multicentre, international, randomised, phase 3 open-label
trial, 222 patients from 53 centres in 10 countries globally were enrolled
and randomised to receive VELCADE either subcutaneously (SC) or intravenously

The study results demonstrated that the efficacy of VELCADE in patients
with relapsed multiple myeloma was similar with SC and IV administration with
respect to complete and partial response rates, time to disease progression,
progression-free survival, one-year survival, time to response and duration
of response. The data highlight the efficacy of VELCADE irrespective of its
route of administration. Median progression-free survival was 10.2 months in
the SC arm compared to 8.0 months in the IV arm, and one year overall
survival was 72.6 percent in the SC group and 76.7 percent in the IV arm.

Some safety advantages were also observed with SC administration. The
incidence of grade greater than or equal to 3 treatment emergent adverse
events was 57 percent for SC vs. 70 percent for IV administration.

The incidences of the following adverse events were significantly lower
in the SC compared to the IV arm: any peripheral neuropathy (PN) (38 percent
SC vs. 53 percent IV), grade 3 and higher PN (6 percent SC vs. 16 percent
IV), and gastrointestinal disorders (37 percent SC vs. 58 percent IV).

SC administration of VELCADE also demonstrated acceptable local
tolerability. Only 6 percent of patients had at least one SC local injection
site reaction reported as an adverse event, with the most common being
redness. All local injection site reactions were resolved with a median time
to resolution of 6 days.

"We are very encouraged by the findings from this study as subcutaneous
administration of Velcade would be a good option for multiple myeloma
patients as it is easier to administer and could improve patient compliance.
There are also advantages where venous access is difficult and also for those
patients who are at risk of developing peripheral neuropathy," says Professor
Philippe Moreau, University Hospital, Nantes, France.

Velcade administered intravenously is effective as maintenance

Results from the UPFRONT study were also presented at the meeting. The
results showed that combination therapy with three VELCADE-based regimes
(VcD: Vc-dexamethasone, VcTD: Vc-thalidomide-dexamethasone, and VcMP:
Vc-melphalan-prednisone) followed by VELCADE maintenance monotherapy in
previously untreated multiple myeloma patients ineligible for high-dose
therapy and stem cell transplantation improved complete response and also
very good partial response rates as compared to the rates with induction.[2]
Quality of life was also assessed, and the study showed that by the end of
the treatment period, patients who received one of the three VELCADE-based
regimens reported significant improvements in quality of life compared with
baseline values.[3]

All three VELCADE-based regimens showed substantial efficacy after eight
cycles, with objective response rates of 68 percent, 78 percent and 71
percent for VcD, VcTD, and VcMP, respectively. After five cycles of VELCADE
maintenance, the objective response rate increased to 71 percent, 79 percent,
and 73 percent in the VcD, VcTD, and VcMP arms, respectively.

Complete response / near complete response rates increased after
maintenance treatment with VELCADE in all treatment arms.

"These data are very significant given that elderly and infirm patients
can further benefit from prolonged VELCADE monotherapy, achieving more robust
and sustained responses over time with lesser toxicity," says Professsor
Ruben Niesvizky, Centre of Excellence for Lymphoma and Myeloma, Weill Cornell
Medical College, New York Presbyterian Hospital, NY.

IV Velcade well tolerated as maintenance monotherapy

In terms of tolerability, maintenance with VELCADE monotherapy was well
tolerated when administered after all three induction regimens. The rates of
severe adverse events were similar at the end of the five cycles of VELCADE
maintenance as they were after the eight induction cycles for all three
treatment arms.

After 13 treatment cycles, the five most common grade greater than or
equal to3 adverse events were peripheral neuropathy (18 percent, 28 percent,
and 21 percent for VcD, VcTD, and VcMP, respectively), fatigue (10 percent,
15 percent, 8 percent), diarrhoea (11 percent, 5 percent, 10 percent),
neutropenia (1 percent, 3 percent, 21 percent), and pneumonia (11 percent,
6 percent, 6 percent). Study drug discontinuation due to adverse events was
highest in the VcTD arm (41 percent, vs. 29 percent with VcD and 35 percent
with VcMP).

About Multiple Myeloma

Multiple myeloma, a cancer of the blood, is the second most common
haematological malignancy; it accounts for 1 percent of all cancers.[4]
Estimates by the European Network of Cancer Registries suggest there are
21,420 new cases of multiple myeloma in Europe each year and around 15,000
deaths from this illness. It is estimated that 60,000 people in Europe are
currently living with multiple myeloma.[4] Traditionally, multiple myeloma
was associated with a poor prognosis, with a median survival of 3-5 years
from diagnosis.

The focus of treatment in multiple myeloma is generally not curative;
instead the primary goal is to reduce symptoms and improve quality of life.
The choice of treatment is influenced by the age and general health of the
patient, the number and types of previous treatments and the complications of
the disease.[5]

Notes to editors

About VELCADE (bortezomib)

Velcade is co-developed by Millennium: The Takeda Oncology Company and
Ortho Biotech Oncology Research & Development, a unit of Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. Millennium: The Takeda Oncology
Company is responsible for commercialization of VELCADE in the U.S.,
Janssen-Cilag is responsible for commercialization in Europe and the rest of
the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical
K.K. entered into a co-promote agreement in May 2010 for VELCADE in Japan.
VELCADE is approved in more than 90 countries and has been used to treat more
than 160,000 patients worldwide.

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 at


[1] Moreau P et al. A Phase 3 Prospective Randomized International Study
(MMY-3021) Comparing Subcutaneous and Intravenous Administration of
Bortezomib In Patients with Relapsed Multiple Myeloma. Abstract presented at
American Society of Hematology Annual Meeting 2010.

[2] Niesvizky R et al. Phase 3b UPFRONT Study: Safety and Efficacy of
Weekly Bortezomib Maintenance Therapy After Bortezomib-Based Induction
Regimens in Elderly, Newly Diagnosed Multiple Myeloma Patients. Abstract
presented at American Society of Hematology Annual Meeting 2010.

[3] Niesvizky R et al. Phase 3b Patient-Reported Quality of Life in
Elderly, Newly Diagnosed Multiple Myeloma Patients Treated with
Bortezomib-Based Regimens: Results from the Phase 3b UPFRONT Study. Abstract
presented at American Society of Hematology Annual Meeting 2010.

[4] European Network of Myeloma Patient Groups

[5] Smith A et al. Guidelines on the diagnosis and management of multiple
myeloma. British Journal of Haematology 2005; 132: 410-451. Available at accessed November 2010

The original language of this press release is English . Translations
into French, German and Spanish are provided by PR Newswire as a courtesy.


For further information please contact: Satu Glawe, Communications & Public Affairs EMEA, Cell +49-172-294-6264; Brigitte Byl, Communications & Public Affairs EMEA, Phone +32(0)14-60-71-72

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