PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol-Myers
Squibb Company (NYSE:BMY) today announced that it received
the 2015 Collaborator Award from the Multiple Myeloma Research
Foundation (MMRF) in recognition of the company’s commitment to
collaboration and to advancing the research and development of novel
therapies for patients with multiple myeloma. Bristol-Myers Squibb
accepted the award as part of the MMRF Satellite Symposium at the 57th
American Society of Hematology Annual Meeting and Exposition on December
4, 2015.
“This award is especially meaningful to Bristol-Myers Squibb. We are
proud of the long-standing partnership with the MMRF, which has allowed
us to achieve our shared goals of providing hope to those fighting this
terrible cancer,” said Michael Giordano, M.D., senior vice president,
Head of Development, Oncology, Bristol-Myers Squibb. “We applaud the
MMRF for driving innovation in this space, and we look forward to
working with the organization and the broader multiple myeloma community
– including the patients, families, and healthcare professionals who
participate in our clinical trial program – to continue to advance
research that can deliver improved outcomes for patients.”
The Collaborator Award is part of an annual initiative by the MMRF to
recognize the exceptional work of its partners from industry and
academia who have played a critical role toward fulfilling the
organization’s mission: to pursue innovative means that accelerate the
development of next-generation multiple myeloma treatments to extend the
lives of patients and ultimately lead to a cure.
“We are excited to present this award to Bristol-Myers Squibb which
acknowledges their leadership in scientific innovation and unwavering
commitment to multiple myeloma. We appreciate their dedication to
understanding and embracing the complex needs of multiple myeloma
patients, to respond to healthcare professionals as they work to better
fight this disease, and to bring it all together in profound service to
our community,” said Walter M. Capone, president and chief executive
officer, MMRF. “All of us at the MMRF and Multiple Myeloma Research
Consortium, our research partners, and all of the patients for whom we
tirelessly work are sincerely grateful for Bristol-Myers Squibb’s shared
dedication to multiple myeloma.”
The award was announced shortly following the U.S. Food and Drug
Administration’s (FDA) approval on November 30, 2015, of Bristol-Myers
Squibb’s Empliciti™ (elotuzumab) as a combination therapy with
Revlimid® (lenalidomide) and dexamethasone for the treatment
of patients with multiple myeloma who have received one to three prior
therapies. With Empliciti, Bristol-Myers Squibb is providing a
new approach to treating multiple myeloma, as it is the first and only
immunostimulatory antibody approved for treatment of the disease.
About Empliciti
Empliciti is an immunostimulatory antibody that specifically
targets Signaling Lymphocyte Activation Molecule Family member 7
(SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma
cells independent of cytogenetic abnormalities. SLAMF7 is also expressed
on Natural Killer cells, plasma cells, and at lower levels on specific
immune cell subsets of differentiated cells within the hematopoietic
lineage.
Empliciti has a dual mechanism-of-action. It directly activates
the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti
also targets SLAMF7 on myeloma cells, tagging these malignant cells for
Natural Killer cell-mediated destruction via antibody-dependent cellular
toxicity.
Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with
Bristol-Myers Squibb solely responsible for commercial activities. Prior
to approval, Empliciti was granted Breakthrough Therapy
Designation by the FDA for use in combination with lenalidomide and
dexamethasone for the treatment of multiple myeloma in patients who have
received one to three prior therapies. According to the FDA,
Breakthrough Therapy Designation is intended to expedite the development
and review of drugs for serious or life-threatening conditions. The
criteria for Breakthrough Therapy Designation requires preliminary
clinical evidence that demonstrates the drug may have substantial
improvement on at least one clinically significant endpoint over
available therapy.
About Multiple Myeloma
Multiple myeloma is a hematologic, or blood, cancer that develops in the
bone marrow. It occurs when a plasma cell, a type of cell in the soft
center of bone marrow, becomes cancerous and multiplies uncontrollably.
Common symptoms of multiple myeloma include bone pain, fatigue, kidney
impairment, and infections.
Despite advances in multiple myeloma treatment over the last decade,
less than half of patients survive for five or more years after
diagnosis. A common characteristic for many patients is that they
experience a cycle of remission and relapse, in which they stop
treatment for a short time, but eventually return to a treatment shortly
after. It is estimated that annually, more than 114,200 new cases of
multiple myeloma are diagnosed and more than 80,000 people die from the
disease globally.
EMPLICITI (elotuzumab) INDICATIONS & IMPORTANT SAFETY INFORMATION
INDICATION
EMPLICITI™ (elotuzumab) is indicated in combination with lenalidomide
and dexamethasone for the treatment of patients with multiple myeloma
who have received one to three prior therapies.
IMPORTANT SAFETY INFORMATION
Infusion Reactions
-
EMPLICITI can cause infusion reactions. Common symptoms include fever,
chills, and hypertension. Bradycardia and hypotension also developed
during infusions. In the trial, 5% of patients required interruption
of the administration of EMPLICITI for a median of 25 minutes due to
infusion reactions, and 1% of patients discontinued due to infusion
reactions. Of the patients who experienced an infusion reaction, 70%
(23/33) had them during the first dose. If a Grade 2 or higher
infusion reaction occurs, interrupt the EMPLICITI infusion and
institute appropriate medical and supportive measures. If the infusion
reaction recurs, stop the EMPLICITI infusion and do not restart it on
that day. Severe infusion reactions may require permanent
discontinuation of EMPLICITI therapy and emergency treatment.
-
Premedicate with dexamethasone, H1 Blocker, H2 Blocker, and
acetaminophen prior to infusing with EMPLICITI.
Infections
-
In a clinical trial of patients with multiple myeloma (N=635),
infections were reported in 81.4% of patients in the EMPLICITI with
lenalidomide/dexamethasone arm (ERd) and 74.4% in the
lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28%
(ERd) and 24.3% (Rd). Opportunistic infections were reported in 22%
(ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and 5.4% (Rd).
Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to
infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5%
(ERd) and 2.2% (Rd). Monitor patients for development of infections
and treat promptly.
Second Primary Malignancies
-
In a clinical trial of patients with multiple myeloma (N=635),
invasive second primary malignancies (SPM) were 9.1% (ERd) and 5.7%
(Rd). The rate of hematologic malignancies were the same between ERd
and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd)
and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd).
Monitor patients for the development of SPMs.
Hepatotoxicity
-
Elevations in liver enzymes (AST/ALT greater than 3 times the upper
limit, total bilirubin greater than 2 times the upper limit, and
alkaline phosphatase less than 2 times the upper limit) consistent
with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients
experiencing hepatotoxicity discontinued treatment; however, 6 out of
8 patients had resolution and continued treatment. Monitor liver
enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation
of liver enzymes. After return to baseline values, continuation of
treatment may be considered.
Interference with Determination of Complete Response
-
EMPLICITI is a humanized IgG kappa monoclonal antibody that can be
detected on both the serum protein electrophoresis and immunofixation
assays used for the clinical monitoring of endogenous M-protein. This
interference can impact the determination of complete response and
possibly relapse from complete response in patients with IgG kappa
myeloma protein.
Pregnancy/Females and Males of Reproductive Potential
-
There are no studies with EMPLICITI with pregnant women to inform any
drug associated risks.
-
There is a risk of fetal harm, including severe life-threatening human
birth defects associated with lenalidomide and it is contraindicated
for use in pregnancy. Refer to the lenalidomide full prescribing
information for requirements regarding contraception and the
prohibitions against blood and/or sperm donation due to presence and
transmission in blood and/or semen and for additional information.
Adverse Reactions
-
Infusion reactions were reported in approximately 10% of patients
treated with EMPLICITI with lenalidomide and dexamethasone. All
reports of infusion reaction were Grade 3 or lower. Grade 3 infusion
reactions occurred in 1% of patients.
-
Serious adverse reactions were 65.4% (ERd) and 56.5% (Rd). The most
frequent serious adverse reactions in the ERd arm compared to the Rd
arm were: pneumonia (15.4%, 11%), pyrexia (6.9%, 4.7%), respiratory
tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism
(3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
-
The most common adverse reactions in ERd and Rd, respectively (>20%)
were fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%,
24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral
neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper
respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%,
12.6%), and pneumonia (20.1%, 14.2%).
Please see the full Prescribing Information here.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information about
Bristol-Myers Squibb, visit www.bms.com
or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and
could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be guaranteed.
Forward-looking statements in this press release should be evaluated
together with the many uncertainties that affect Bristol-Myers Squibb's
business, particularly those identified in the cautionary factors
discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the
year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and
our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement, whether as
a result of new information, future events or otherwise.
Endnotes:
Empliciti is a trademark of Bristol-Myers Squibb Company.
Revlimid is a registered trademark of Celgene Corporation.
© 2015 Bristol-Myers Squibb Company. All rights reserved.
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Source: Bristol-Myers Squibb Company