Positive opinion based on reduction in the
risk of disease progression or death with Empliciti in
combination with standard of care regimen for multiple myeloma
demonstrated in ELOQUENT-2 study
Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV)
today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion recommending that Empliciti (elotuzumab), an
investigational immunostimulatory antibody, be granted approval for
the treatment of multiple myeloma as combination therapy with
Revlimid® (lenalidomide) and dexamethasone in patients who have
received at least one prior therapy. The application now will be
reviewed by the European Commission, which has the authority to
approve medicines for the European Union (EU).
“Today’s positive CHMP recommendation means we are one step
closer to offering a new type of treatment for patients in Europe
with multiple myeloma who have received at least one prior
therapy,” said Michael Giordano, M.D., senior vice president, head
of Development, Oncology, Bristol-Myers Squibb. “We look forward to
the European Commission’s decision and the opportunity to extend
our leading Immuno-Oncology science to patients with multiple
myeloma.”
The CHMP positive opinion is based on data from the Phase 3,
open-label ELOQUENT-2 study, which evaluated Empliciti in
combination with lenalidomide and dexamethasone (ERd) versus
lenalidomide and dexamethasone (Rd) alone. The results of this
trial showed a 30% reduction in the risk of disease progression or
death with ERd compared to Rd alone and, at the two year time
point, ERd delivered a 52% relative improvement in progression-free
survival. 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%). These results were published in The New England
Journal of Medicine on June 2, 2015.
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.
On November 30, 2015, the U.S. Food and Drug Administration
approved Empliciti in combination with lenalidomide and
dexamethasone in patients with multiple myeloma who have received
one to three prior therapies. The safety and efficacy of Empliciti
is still being evaluated by other health authorities.
Bristol-Myers Squibb and AbbVie are co-developing Empliciti,
with Bristol-Myers Squibb solely responsible for commercial
activities.
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.
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 US 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.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company
formed in 2013 following separation from Abbott Laboratories. The
company's mission is to use its expertise, dedicated people and
unique approach to innovation to develop and market advanced
therapies that address some of the world's most complex and serious
diseases. Together with its wholly-owned subsidiary, Pharmacyclics,
AbbVie employs more than 28,000 people worldwide and markets
medicines in more than 170 countries.
For further information on the company and its people, portfolio
and commitments, please visit www.abbvie.com.
Follow @abbvie on Twitter or view careers on
our Facebook or LinkedIn page.
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.
Forward-Looking Statements
Some statements in this news release may be forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995. The words "believe," "expect," "anticipate," "project"
and similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," in
AbbVie's 2014 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
Endnotes
Empliciti is a trademark of Bristol-Myers Squibb Company.
Revlimid is a registered trademark of Celgene Corporation.
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version on businesswire.com: http://www.businesswire.com/news/home/20160129005421/en/
Bristol-Myers Squibb CompanyMedia:Audrey Abernathy,
609-419-5375Cell:
919-605-4521audrey.abernathy@bms.comorInvestors:Ranya
Dajani, 609-252-5330ranya.dajani@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.com
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