BOUDRY, Switzerland--(BUSINESS WIRE)--Oct. 23, 2012--
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ:
CELG) today announced that its phase III, multi-center, randomized,
open-label study (MM-003) of pomalidomide plus low-dose dexamethasone
compared to high-dose dexamethasone in patients with relapsed and/or
refractory multiple myeloma was reviewed by a data safety monitoring
board (DSMB). The DSMB determined MM-003 met the primary endpoint of
improvement in progression-free survival (PFS) at the PFS final
analysis. Additionally, at the OS interim analysis, the study crossed
the superiority boundary for overall survival (OS), a key secondary
endpoint that the study was also powered to evaluate. Improvements in
PFS and OS were both highly statistically significant and clinically
meaningful. As a result, the DSMB recommended that patients who had not
yet progressed in the high-dose dexamethasone arm should be crossed-over
to the pomalidomide plus low-dose dexamethasone arm.
Safety results observed in MM-003 were consistent with previous studies
of pomalidomide in relapsed/refractory multiple myeloma patients. Full
data from the study are being prepared for submission to a future
medical meeting for presentation.
“The survival results in this study build on earlier observations of
high response rates for pomalidomide and dexamethasone in multiple
myeloma patients who had been exposed to multiple therapies, including
immunomodulatory agents and proteasome inhibitors,” said Dr. Jesus San
Miguel, Head of the Department of Hematology at the University of
Salamanca, Director of the Biomedical Research Institute of Salamanca
and principal investigator in the study. “The continued progress of new
agents in this area of disease, particularly in later-stage patients is
critical as we look to extend remissions and survival for these
The MM-003 study compared pomalidomide plus low-dose dexamethasone to
high-dose dexamethasone in patients who were relapsed on or refractory
to at least two prior therapies that must have included both
lenalidomide and bortezomib.
Patients in the pomalidomide arm received 4 mg of oral pomalidomide on
days 1-21 of each 28-day cycle, with patients 75 years or younger also
receiving 40 mg of oral low-dose dexamethasone and patients older than
75 years receiving 20 mg oral low-dose dexamethasone on days 1, 8, 15
and 22 of each 28-day cycle, until disease progression.
Patients in the comparator arm 75 years and younger received 40 mg oral
high-dose dexamethasone on days 1-4, 9-12 and 17-20 of each 28-day
cycle, and patients older than 75 years received 20 mg oral high-dose
dexamethasone on days 1-4, 9-12 and 17-20 of a 28-day cycle, until
The primary endpoint of the study was PFS, with the key secondary
endpoint being OS (with alpha control), and other secondary endpoints
including safety, response rates and time to progression.
A Marketing Authorisation Application (MAA) for pomalidomide in
combination with dexamethasone was submitted to the EMA in May 2012 and
Celgene anticipates a decision by European regulatory authorities in the
second half of 2013.
Additionally, a new drug application (NDA) has been accepted for review
by the U.S. Food and Drug Administration, with a Prescription Drug User
Fee Act (PDUFA) date of Feb. 10, 2013.
These results are from an investigational study. Pomalidomide is not
approved for the treatment of any indication.
Pomalidomide is an IMiDs® compound. Pomalidomide and other IMiDs
compounds continue to be evaluated in over 100 clinical trials. The
IMiDs compound pipeline is covered by a comprehensive intellectual
property estate of issued and pending patent applications in the US, EU
and other regions.
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
About Celgene International Sàrl
Celgene International Sàrl, located in Boudry, in the Canton of
Neuchâtel, 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 press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans," "will," “outlook” and
similar expressions. Forward-looking statements are based on
management’s current plans, estimates, assumptions and projections, and
speak only as of the date they are made. We undertake no obligation to
update any forward-looking statement in light of new information or
future events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which are
difficult to predict and are generally beyond our control. Actual
results or outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual Report
on Form 10-K and our other reports filed with the Securities and
Source: Celgene International Sàrl
Celgene International Sàrl
+41 32 729 8303
32 729 8304