- First and only immunostimulatory
antibody approved for multiple myeloma
- Approval based on ELOQUENT-2, which
established the combination of Empliciti with lenalidomide
and dexamethasone (Rd) delivered a significant progression-free
survival benefit vs. Rd alone, demonstrated over two years (HR 0.70
[95% CI: 0.57, 0.85; p = 0.0004])
Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV)
today announced the U.S. Food and Drug Administration (FDA) has
approved Empliciti (elotuzumab) for the treatment of multiple
myeloma as combination therapy with Revlimid® (lenalidomide) and
dexamethasone (ERd) in patients who have received one to three
prior therapies. The approval of this first and only
immunostimulatory antibody for multiple myeloma is based on data
from the randomized, open-label, Phase 3, ELOQUENT-2 study, which
demonstrated that the ERd regimen resulted in a 30% reduction in
the risk of disease progression or death compared to Rd alone (HR
0.70 [95% CI: 0.57, 0.85; p = 0.0004]).
This Smart News Release features multimedia.
View the full release here:
http://www.businesswire.com/news/home/20151130006225/en/
Product Photo 1
This press release has an accompanying Smart Marketing Page. You
can access the Smart Marketing Page here.
The co-primary endpoints were progression-free survival (PFS),
as assessed by hazard ratio, and overall response rate (ORR). With
a minimum of two years follow-up, ERd delivered a benefit in PFS
that was maintained over time, with PFS rates of 68% versus 57% at
one year and 41% versus 27% at two years in the ERd and Rd arms,
respectively. The ERd regimen also demonstrated a significant
improvement in ORR, achieving an ORR of 78.5% (95% CI: 73.6% to
82.9%) versus 65.5% in the Rd arm (95% CI: 60.1% to 70.7%). 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%).
“At Bristol-Myers Squibb, we are leading a revolution in cancer
treatment that is changing expectations for patients with some of
the hardest-to-treat cancers. With today’s approval of Empliciti,
we are pleased to now bring the promise of our Immuno-Oncology
research to patients with multiple myeloma,” said Francis Cuss, MB
Bchir, FRCP, chief scientific officer, Bristol-Myers Squibb.
“Empliciti represents a fundamentally different approach of
directly activating the immune system in patients with relapsed or
refractory multiple myeloma, delivering improved outcomes for those
in need.”
Empliciti is available for injection for intravenous use in 300
mg and 400 mg vials. The company expects to begin shipping
Empliciti within the next 48 hours. Empliciti is also under review
by the European Medicines Agency and has been granted accelerated
assessment.
Discontinuation rates due to adverse reactions were similar
across the ERd and Rd control arms (6.0% vs. 6.3%). ERd is
associated with the following Warnings and Precautions: Infusion
Reactions, Infections, Second Primary Malignancies, Hepatotoxicity,
Interference with Determination of Complete Response,
Pregnancy/Females and Males of Reproductive Potential, and Adverse
Reactions. Please see the detailed Important Safety Information and
a link to the Prescribing Information below.
“Multiple myeloma remains largely incurable, with only half of
patients surviving five years after diagnosis,” said Sagar Lonial,
M.D., chief medical officer of the Winship Cancer Institute of
Emory University. “The approval of elotuzumab (Empliciti) provides
renewed hope for the multiple myeloma community who urgently need a
treatment option that extends the time patients live without their
disease progressing.”
"Empliciti in combination with lenalidomide and dexamethasone is
an important new option for patients with multiple myeloma and
healthcare providers who are treating this cancer," said Michael
Severino, M.D., executive vice president of research and
development and chief scientific officer, AbbVie. "AbbVie is
pleased to have partnered with Bristol-Myers Squibb in making this
new treatment available for patients with relapsed or refractory
multiple myeloma."
About ELOQUENT-2
ELOQUENT-2 (CA204-004) is a randomized, open-label, Phase 3
study evaluating Empliciti in combination with lenalidomide and
dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd)
alone in patients with relapsed or refractory multiple myeloma. The
trial enrolled 646 patients who had received one to three prior
therapies. Patients were randomized 1:1 to receive either Empliciti
10 mg/kg in combination with Rd or Rd alone in 4-week cycles until
disease progression or unacceptable toxicity. Baseline patient
demographics and disease characteristics were well balanced between
treatment arms and included a meaningful portion of patients who
were ≥ 65 years old, had high-risk cytogenetics, and/or were
refractory to the most recent line of therapy. The minimum
follow-up for all study subjects was 24 months. The co-primary
endpoints were PFS, as assessed by hazard ratio, and ORR as
determined by a blinded Independent Review Committee using the
European Group for Blood and Marrow Transplantation response
criteria. Results of the ELOQUENT-2 study were published in The New
England Journal of Medicine on June 2, 2015.
The study demonstrated that the ERd regimen resulted in a 30%
reduction in the risk of disease progression or death compared to
Rd alone (HR 0.70 [95% CI: 0.57, 0.85; p = 0.0004]). Additionally,
the PFS rates in the ERd arm versus the Rd arm were 68% versus 57%
at one year and 41% versus 27% at two years, respectively. The ERd
regimen demonstrated a significant improvement in ORR, achieving an
ORR of 78.5% (95% CI, 73.6% to 82.9%; p = 0.0002) in the ERd arm
versus 65.5% in the Rd arm (95% CI, 60.1% to 70.7%). The median PFS
in the ERd group was 19.4 months (95% CI, 16.6 to 22.2) versus 14.9
months (95% CI, 12.1 to 17.2) in the Rd group. At the time of the
interim analysis, there were fewer deaths in the ERd versus Rd
study arm (94 [29%] versus 116 [36%], respectively).
Serious adverse reactions were reported in 65.4% of patients
treated on the ERd arm and 56.5% for patients treated on the Rd
arm. 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%) are 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%). Infusion reactions occurred in 10% of patients
treated with ERd; these adverse events were Grade 3 or lower (Grade
3, 1%; Grade 4, 0%) and were manageable. In the trial, 1% of
patients discontinued due to infusion reactions and 5% of patients
required interruption of the administration of Empliciti for a
median of 25 minutes. Grade 3/4 laboratory abnormalities that
worsened from baseline and had a 10% or higher incidence for ERd
patients and a 5% higher incidence than Rd patients were:
lymphopenia (76.7%, 48.7%), leukopenia (32.4%, 25.6%),
hyperglycemia (17.0%, 10.2%), and hypocalcemia (11.3% and 4.7%).
Overall, the proportion of patients who discontinued treatment due
to adverse reactions was similar for the ERd and Rd arms (6.0% vs.
6.3%, respectively).
“The approval of Empliciti is an innovative advancement in the
treatment of multiple myeloma,” said Walter M. Capone, chief
executive officer and president, The Multiple Myeloma Research
Foundation. “This is an exciting opportunity for patients who
experience relapse and may benefit from this new immunotherapy
treatment."
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 Bristol-Myers Squib’s Patient
Support Programs
Bristol-Myers Squibb is committed to helping patients through
treatment with Empliciti. For support and assistance, patients and
physicians may call 1-844-EMPLICITI. This number offers one-stop
access to a range of support services for patients and healthcare
professionals alike.
About Bristol-Myers Squibb’s Access
Support
Bristol-Myers Squibb is committed to helping patients access
Empliciti and offers numerous programs to support patients and
providers in gaining access. BMS Access Support®, the Bristol-Myers
Squibb Reimbursement Services program, is designed to support
access to BMS medicines and expedite time to therapy through
reimbursement support including Benefit Investigations, Prior
Authorization Facilitation, Appeals Assistance, and assistance for
patient out-of-pocket costs. BMS Access Support assists patients
and providers throughout the treatment journey―whether it is at
initial diagnosis or in support of transition from a clinical
trial. More information about our reimbursement support services
can be obtained by calling 1-800-861-0048 or by visiting
www.bmsaccesssupport.com. For healthcare providers seeking
Empliciti specific reimbursement information, please visit the BMS
Access Support Product section by visiting
www.bmsaccesssupportoncology.com.
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 Reaction
- In a clinical trial of patients with
multiple myeloma (n=365), EMPLICITI caused 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
- 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
- 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%) are 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.
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.
AbbVie 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. BMS
Access Support is a registered trademark of Bristol-Myers Squibb
Company.
Revlimid is a registered trademark of Celgene Corporation.
© 2015 Bristol-Myers Squibb Company. All rights reserved.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151130006225/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
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Apr 2023 to Apr 2024