Celgene International Sàrl (NASDAQ: CELG) today announced results
of a Phase II study of pomalidomide and dexamethasone in multiple
myeloma patients who have failed both lenalidomide and bortezomib. Data
were presented by Dr. Martha Lacy of the Mayo Clinic during the American
Society of Clinical Oncology annual meeting.
Patients with multiple myeloma who have progressed after multiple
therapies have limited treatment options. Pomalidomide, in an earlier
report, demonstrated responses in relapsed multiple myeloma patients
refractory to lenalidomide. Patients refractory to bortezomib were not
evaluated in the earlier report (Lacy et al. ASH 2009. Abstract #429).
In this current analysis of the study, patients who were refractory to
both lenalidomide and bortezomib were given 2mg daily of pomalidomide on
days 1-28 of each 28-day cycle and 40mg daily of oral dexamethasone on
days 1, 8, 15, 22.
The overall response rate (ORR) for these patients was 54% (19/35).
Fourteen percent (5/35) of patients achieved a very good partial
response (VGPR), 17% achieved a partial response (PR) (6/35) and 23%
achieved a minor response (MR) (8/35). Additionally, at 6-month
follow-up, the progression-free survival rate was 58% (95% CI: 42-80)
and the overall survival rate was 86% (95% CI 73-100). The median
progression-free survival was 8 months (95% CI: NA)
The most common grade 3 or 4 hematologic adverse events were neutropenia
(34% 12/35), anemia (9% 3/35) and thrombocytopenia (9% 3/35).
These data are from an investigational study of pomalidomide, which is
not approved for marketing.
About Pomalidomide
Pomalidomide is an IMiDs® compound, a member of a proprietary
group of novel immunomodulatory agents. These immunomodulatory agents,
taken orally, have unique multiple mechanisms of action that involve the
microenvironment of the cancer cell, not just the malignant cell itself.
The IMiDs 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 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. Most patients with multiple myeloma, however,
have cells that produce a form of immunoglobulin called paraprotein (or
M protein), which 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 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 release contains certain forward-looking statements which
involve known and unknown risks, delays, uncertainties and other factors
not under the Company’s control. The Company’s actual results,
performance, or achievements could be materially different from those
projected by these forward-looking statements.
The factors that
could cause actual results, performance, or achievements to differ from
the forward-looking statements are discussed in the Company’s filings
with the Securities and Exchange Commission, such as the Company’s Form
10-K, 10-Q and 8-K reports.
Given these risks and uncertainties,
you are cautioned not to place undue reliance on the forward-looking
statements.
