Celgene International Sarl (NASDAQ: CELG) announced that results
from the Southwest Oncology Group (SWOG) Phase III randomized,
controlled trial evaluating REVLIMID (lenalidomide) and the steroid
dexamethasone were presented for the first time at the 49th annual
American Society of Hematology (ASH) Meeting. The SWOG (S0232) study
(Abstract #77) evaluated the combination therapy of REVLIMID and
dexamethasone in patients with newly diagnosed multiple myeloma and
found that patients given the treatment regimen had superior response
rates and progression-free survival compared to those who received
dexamethasone alone.
According to Brian G.M. Durie, M.D., Chairman of the International
Myeloma Foundation and co-chair of the SWOG Myeloma Committee,
"REVLIMID with standard dose dexamethasone is among the most active
up-front combination regimens against myeloma."
Overall response rate in patients receiving REVLIMID and
dexamethasone was 85.3% with 22.1% of patients achieving complete
responses compared to 51.3% and 3.8%, respectively in the
dexamethasone only group. Additionally, estimated one year
progression-free survival was 77% in patients who received the
combined therapy compared to 55% who received dexamethasone alone. The
one-year overall survival rates in both arms of the study are among
the highest ever reported (93% and 91%), influenced by the fact that
patients in the dexamethasone only arm crossed over and received
REVLIMID and dexamethasone, at the time of progression or when the
study was halted.
"These results demonstrate that REVLIMID plus dexamethasone is an
excellent treatment in newly diagnosed multiple myeloma," said Dr.
Durie. "Additionally, REVLIMID offers a quality of life advantage
through its oral formulation and rare incidence of peripheral
neuropathy, a treatment-limiting side effect."
The SWOG trial permanently closed enrollment in May after the
preliminary one-year survival results from the Eastern Cooperative
Oncology Group (ECOG) Phase III study (E4A03) were released. The ECOG
trial showed an unprecedented survival advantage in using REVLIMID and
low-dose dexamethasone in newly diagnosed multiple myeloma patients.
Grade 3/4 adverse events were more frequent in multiple myeloma
patients who received the combination of lenalidomide/dexamethasone
compared to dexamethasone alone. Neutropenia (13.5%; 27/198) and
infections (19.1%, 38/198) were the most frequently reported adverse
events. DVT occurred in 25% of patients receiving REVLIMID and
dexamethasone compared to 7% with dexamethasone alone, however, with
the use of aspirin as a prophylaxis the DVT events were 14% and 12%
respectively.
About REVLIMID(R)
REVLIMID is an oral medication currently approved in the United
States, the EU and Switzerland for treatment of patients with multiple
myeloma in combination with dexamethasone who have received at least
one prior therapy. REVLIMID is also approved in the United States for
transfusion-dependent anemia due to low- or intermediate-1-risk MDS
associated with a deletion 5q cytogenetic abnormality with or without
additional cytogenetic abnormalities. REVLIMID has obtained Orphan
Drug designation in the EU, U.S., Switzerland and Australia.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is
a cancer of the blood in which malignant plasma cells are overproduced
in the bone marrow. Plasma cells are white blood cells that help
produce antibodies called immunoglobulins that fight infection and
disease. However, most patients with multiple myeloma have cells that
produce a form of immunoglobulin called paraprotein (or M protein)
that does not benefit the body. In addition, the malignant plasma
cells replace normal plasma cells and other white blood cells
important to the immune system. Multiple myeloma cells can also attach
to other tissues of the body, such as bone, and produce tumors. The
cause of the disease remains unknown.
About Celgene International Sarl
Celgene International Sarl, located in Boudry, Switzerland, is a
wholly owned subsidiary and international headquarters of Celgene
Corporation. Celgene Corporation, headquartered in Summit, New Jersey,
is an integrated global pharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through gene and protein regulation. For more information, please
visit the Company´s website at www.celgene.com.
This release contains certain forward-looking statements which
involve known and unknown risks, delays, uncertainties and other
factors not under the Company´s control, which may cause actual
results, performance or achievements of the Company to be materially
different from the results, performance or other expectations implied
by these forward-looking statements. These factors include results of
current or pending research and development activities, actions by the
FDA and other regulatory authorities, and those factors detailed in
the Company´s filings with the Securities and Exchange Commission such
as Form 10-K, 10-Q and 8-K reports.
