Best Overall Response Achieved in Both Low-Dose and High-Dose Arms of the Study Were 71% and 82% Respectively
CR/VGPR Rates Achieved in Both Low-Dose and High-Dose Arms of the Study Were 42% and 52% Respectively
Median Duration of Response Not Yet Reached after 21 Months Follow-up
Patients Who Continued on Treatment past 6 Months from Both the Low-Dose and High-Dose Arms of the Trial Achieved 99% and 97% One-Year Survival Rates Respectively
REVLIMID Plus Low-Dose Dexamethasone Improves One-Year (96% and 88% Respectively) and Two-Year (87% and 75% Respectively) Survival Over REVLIMID Plus High-Dose Dexamethasone
Of Patients Who Went to Stem Cell Harvest, 97% Achieved Successful Stem Cell Collection
Favorable Safety Profile Including Very Low Incidence of Peripheral Neuropathy
Preferred Oral Regimen Offers New Treatment Option for Patients
Celgene International Sarl (NASDAQ: CELG) announced that updated clinical data from the Eastern Cooperative Oncology Group´s (ECOG) large, randomized Phase III trial evaluating oral REVLIMID
(lenalidomide) with low-dose dexamethasone continued to demonstrate superior overall survival rates for newly diagnosed multiple myeloma patients compared to REVLIMID with the standard high-dose
dexamethasone. Overall survival, the most important outcome for patients and physicians, is 96% at one year and 87% at two years. The efficacy data (Abstract #74), presented today at the 49th annual
meeting of the American Society of Hematology (ASH), for the first time expand on initial safety analysis presented in June.
"This is a landmark trial that supports the continuing paradigm
shift in the treatment of myeloma and other blood cancers," said
Jean-Luc Harousseau, M.D., founding member of the Intergroupe
Francophone du Myelome. "We are seeing long-term results with fewer
side effects in patients of all ages. These are the best survival data
we have seen in newly diagnosed multiple myeloma."
REVLIMID(R) was active with both dose levels of dexamethasone. The
best overall response for high-dose dexamethasone (CR/VGPR/PR) was 82%
compared to 71% in the low-dose dexamethasone arm, including 52% and
42% CR/VGPR. After a median 21 months follow-up, the median duration
of response has not been met in either arm. While the low dose arm had
lower response rates, it was associated with superior overall
survival. Additionally, time to disease progression and
progression-free survival were similar in both arms of the study.
The 87% survival rate in the arm with REVLIMID and low-dose
dexametheason at two years showed an advantage compared to the two
year survival rate of 75% for patients who received REVLIMID and
high-dose dexamethasone. Increased overall survival was seen in
patients receiving REVLIMID and low-dose dexamethasone regardless of
age, however patients under the age of 65 showed a two year survival
probability of 91% compared to 85% using high-dose dexamethasone at
two years. In patients who continued on treatment past 6 months, the
99% survival rate showed an advantage compared to a survival rate of
97% for patients who received REVLIMID and high-dose dexamethasone at
one year.
97% of patients in both arms of the study who decided to undergo
stem cell harvest were successfully harvested.
Lowering the dose of dexamethasone in combination with REVLIMID
reduced major grade 3 or higher non-hematologic toxicities, including
deep vein thrombosis (DVT)/pulmonary embolism (PE) (9% vs. 25%).
Neutropenia in the REVLIMID/low-dose dexamethasone arm (19%) was
slightly increased compared to REVLIMID/high-dose dexamethasone,
although infections were lower in the low-dose dexamethasone arm (7%
vs. 14%). Grade 4 toxicities were also significantly lower in the
low-dose arm (8%), compared to 19% in the high-dose arm.
"The lower survival rates with the high dose dexamethasone can be
attributed to disease progression as well as treatment-related
toxicities," said S. Vincent Rajkumar, M.D., Mayo Clinic Cancer Center
hematologist and lead investigator of the study. "This is a major
advance in the treatment of this cancer, and also gives researchers a
new direction to explore -- that more is not necessarily better."
Last April, the ECOG Data Monitoring Committee reviewed the
preliminary results from the trial and recommended that the survival
results be made public because of the early differences seen in the
overall survival rates. All patients in the high-dose dexamethasone
arm of the clinical trial were moved to the lose-dose arm based upon
these interim findings at that time as well. As a result of these
findings, REVLIMID is the foundation for several upcoming newly
diagnosed multiple myeloma trials: ECOG E4A03, SWOG S0232, INTERGROUP,
S0777, IFM 07-01, ECOG E1A06, and Celgene-sponsored trial MM-020.
About REVLIMID(R)
REVLIMID is 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.