Investigational treatment demonstrates
favorable early safety and efficacy data in patients who had
received a median five prior treatments including immunomodulatory
agents, proteasome inhibitors and anti-CD38 agents
Celgene Corporation (NASDAQ: CELG) today announced the first
clinical results evaluating iberdomide (CC-220) in combination with
dexamethasone in patients with relapsed and refractory multiple
myeloma from the ongoing phase 1/2 CC-220-MM-001 study during an
oral presentation at the 2019 American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago.
The results included preliminary safety and efficacy data from
the ongoing multicenter, open-label, dose-escalation study, which
aims to determine the maximum tolerated dose and the recommended
phase 2 dose of iberdomide in combination with dexamethasone.
Iberdomide is Celgene’s proprietary cereblon E3 ligase modulator
(CELMoD®) compound with enhanced tumoricidal and immune stimulatory
effects demonstrated in preclinical studies. The phase 1/2 study is
expected to enroll approximately 300 participants.
“Nearly half a million people globally are affected by multiple
myeloma, a cancer of plasma cells. The management of patients with
late relapsed or refractory multiple myeloma continues to be
challenging due to the complex nature of the disease’s
pathophysiology. Despite the introduction of newer agents, patients
continue to experience disease relapse therefore new therapeutic
options are needed for patients who have failed multiple prior
treatments,” said Sagar Lonial, MD, Chief Medical Officer at
Winship Cancer Institute of Emory University. “The early data on
iberdomide in combination with dexamethasone in these heavily
pretreated patients show promising activity, and we look forward to
advancing our understanding of this combination’s potential in this
patient population.”
As of April 2019, 66 patients at a median age of 65 received the
iberdomide plus dexamethasone combination, with iberdomide being
administered in 8 incremental doses ranging from 0.3 mg to 1.3 mg.
Escalating doses of iberdomide were given on days 1 through 21 in
combination with dexamethasone (40 mg; 20 mg in patients older than
75) on days 1, 8, 15, and 22 of each 28-day cycle. Patients had a
median of five prior multiple myeloma treatment regimens, which
could have included stem cell transplant, immunomodulatory drugs
including lenalidomide and pomalidomide, proteasome inhibitors and
daratumumab.
Grade 3-4 adverse events (AE) reported included neutropenia
(29%), infection (26%), anemia (24%), thrombocytopenia (12%),
pulmonary embolism (1.5%) and peripheral sensory neuropathy (1.5%).
Six patients (9%) discontinued treatment due to adverse events.
Of the 66 patients who received the iberdomide plus
dexamethasone combination, 59 were evaluable for response. The
overall response rate was 32% (19/59), with 29% (17/59) achieving a
partial response and two patients achieving a very good partial
response.
Patients (n=51) who were refractory to IMiD® compounds, which
included lenalidomide and pomalidomide, had an overall response
rate of 35% (18/51) with 33% (17/51) of patients achieving a
partial response and one patient achieving a very good partial
response. Further, patients who were refractory to both daratumumab
and pomalidomide (n=27) had an overall response rate of 29% (8/27),
with 25% (7/27) achieving a partial response and one patient
achieving a very good partial response. Maximum tolerated dose and
the recommended phase 2 dose have not yet been determined.
“While we have made tremendous progress in treating multiple
myeloma, there is still a significant need for new options to
address the heterogeneous nature of the disease. We are focused on
exploring the potential of our next generation CELMoD compounds to
help fill this gap,” said Dr. Alise Reicin, President, Global
Clinical Development for Celgene. “The preliminary clinical
activity and favorable safety data observed with the combination of
iberdomide and dexamethasone are encouraging, particularly in
patients who have failed multiple lines of therapy including
patients who were refractory to lenalidomide, pomalidomide and/or
daratumumab.”
The phase 1/2 study is also evaluating iberdomide as monotherapy
and in combination with daratumumab or bortezomib or carfilzomib.
Iberdomide is investigational and has not been approved in any
country.
About Iberdomide (CC-220)
Iberdomide is an investigational cereblon E3 ligase modulator
(CELMoD®) compound that induces degradation of transcription
factors Aiolos and Ikaros, thereby inhibiting growth of myeloma
cells in vitro. In pre-clinical models, iberdomide has demonstrated
ability to destroy tumor cells, stimulate an immune response,
overcome resistance to immunomodulatory drugs, and synergize with
dexamethasone, daratumumab and bortezomib.
About CC-220-MM-001
The open-label phase 1/2 CC-220-MM-001 dose escalation study
(NCT02773030) seeks to determine the maximum tolerated dose and
recommended phase 2 dose of iberdomide (CC-220) as monotherapy and
in combination with dexamethasone, as well as further evaluate
safety and preliminary efficacy in patients with
relapsed/refractory multiple myeloma. The study consists of a
dose-escalation portion (Part 1) as well as an expansion of these
two cohorts at the recommended phase 2 dose to further evaluate
safety and estimate preliminary efficacy (Part 2). The study also
seeks to establish the maximum tolerated dose and recommended phase
2 dose of iberdomide when administered in combination with
daratumumab or bortezomib or carfilzomib.
About Multiple Myeloma
Multiple myeloma is a life-threatening blood cancer that is
characterized by tumor proliferation and suppression of the immune
system.1 It is a rare but deadly disease – more than 32,000
new cases will be diagnosed in the United States in 2019, and
approximately 13,000 deaths will occur in 2019, representing about
2.1% of all cancer-related deaths.2 The typical multiple myeloma
disease course includes periods of symptomatic myeloma followed by
periods of remission, and eventually, the disease becomes
refractory (nonresponsive).
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow Celgene
on Social Media: Twitter, Pinterest, LinkedIn, Facebook and
YouTube.
FORWARD-LOOKING STATEMENTS
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 U.S.
Securities and Exchange Commission, including factors related to
the proposed transaction between Bristol-Myers Squibb and Celgene,
such as, but not limited to, the risks that: management’s time and
attention is diverted on transaction related issues; disruption
from the transaction make it more difficult to maintain business,
contractual and operational relationships; legal proceedings are
instituted against Bristol-Myers Squibb, Celgene or the combined
company could delay or prevent the proposed transaction; and
Bristol-Myers Squibb, Celgene or the combined company is unable to
retain key personnel.
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All trademarks are the property of their respective owners.
1 Palumbo A and Anderson K. Multiple myeloma. N Engl J Med.
2011;364:1046-1060.2 National Cancer Institute. Cancer Stat Facts:
Myeloma. Available at:
https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed April
2019.
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