Bristol-Myers Squibb Company (NYSE:BMY) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency has adopted a positive opinion on a
Type-II variation application for Empliciti (elotuzumab) plus
pomalidomide and low-dose dexamethasone (EPd) for the treatment of
adult patients with relapsed and refractory multiple myeloma who
have received at least two prior therapies, including lenalidomide
and a proteasome inhibitor (PI), and have demonstrated disease
progression on the last therapy. The CHMP recommendation will now
be reviewed by the European Commission, which has the authority to
approve medicines for the European Union.
“The positive opinion by the CHMP further validates the
potential of this Empliciti-based combination to help patients with
multiple myeloma who have relapsed or are refractory to prior
therapies, a setting particularly in need of additional treatment
options given the majority of patients with multiple myeloma will
relapse,” said Fouad Namouni, M.D., head, Oncology Development,
Bristol-Myers Squibb.
The application is based on data from ELOQUENT-3, a randomized
Phase 2 study evaluating pomalidomide and dexamethasone with or
without Empliciti in patients with refractory or relapsed and
refractory multiple myeloma. The U.S. Food and Drug Administration
approved EPd for the treatment of adult patients with multiple
myeloma who have received at least two prior therapies, including
lenalidomide and a PI, in November 2018.
Bristol-Myers Squibb and AbbVie are co-developing Empliciti,
with Bristol-Myers Squibb solely responsible for commercial
activities.
About ELOQUENT-3
ELOQUENT-3 is a randomized Phase 2 study evaluating the addition
of Empliciti to pomalidomide and dexamethasone (EPd) versus
pomalidomide and dexamethasone (Pd) in 117 patients with multiple
myeloma who received two or more prior therapies and were either
refractory or relapsed and refractory to lenalidomide and a PI.
Patients were randomized 1:1 to receive either EPd (n=60) or Pd
alone (n=57) in 28-day cycles until disease progression or
unacceptable toxicity. Patients in both the EPd and Pd arms
received 4 mg of pomalidomide for days 1-21 of each cycle, and the
weekly equivalent of 40 mg or 20 mg dexamethasone for patients ≤75
years or >75 years, respectively. In the EPd arm, Empliciti was
administered at the dose of 10 mg/kg IV weekly for the first two
cycles and 20 mg/kg monthly starting from cycle 3. The primary
endpoint of the study was investigator-assessed progression-free
survival.
Bristol-Myers Squibb: Advancing
Oncology Research
At Bristol-Myers Squibb, patients are at the center of
everything we do. The focus of our research is to increase quality,
long-term survival for patients and make cure a possibility.
Through a unique multidisciplinary approach powered by
translational science, we harness our deep scientific experience in
oncology and Immuno-Oncology (I-O) research to identify novel
treatments tailored to individual patient needs. Our researchers
are developing a diverse, purposefully built pipeline designed to
target different immune system pathways and address the complex and
specific interactions between the tumor, its microenvironment and
the immune system. We source innovation internally, and in
collaboration with academia, government, advocacy groups and
biotechnology companies, to help make the promise of
transformational medicines, like I-O, a reality for patients.
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 also
is 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.
Empliciti was initially approved by the FDA in 2015 in
combination with lenalidomide and dexamethasone for the treatment
of patients with multiple myeloma who have received one to three
prior therapies.
U.S. FDA-APPROVED INDICATIONS FOR
EMPLICITI®
EMPLICITI® (elotuzumab) is indicated in combination with
lenalidomide and dexamethasone for the treatment of adult patients
with multiple myeloma who have received one to three prior
therapies.
EMPLICITI® (elotuzumab) is indicated in combination with
pomalidomide and dexamethasone for the treatment of adult patients
with multiple myeloma who have received at least two prior
therapies including lenalidomide and a proteasome inhibitor.
IMPORTANT SAFETY INFORMATION
Infusion Reactions
Infusion reactions were reported in 10% of patients treated with
EMPLICITI in the ELOQUENT-2 trial [EMPLICITI + lenalidomide +
dexamethasone (ERd) vs lenalidomide + dexamethasone (Rd)] and 3.3%
in the ELOQUENT-3 trial [EMPLICITI + pomalidomide + dexamethasone
(EPd) vs pomalidomide + dexamethasone (Pd)].
In the ELOQUENT-2 trial, all infusion reactions were Grade 3 or
lower, with Grade 3 infusion reactions occurring in 1% of patients.
The most common symptoms included 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.
In the ELOQUENT-3 trial, the only infusion reaction symptom was
chest discomfort (2%), which was Grade 1. All the patients who
experienced an infusion reaction had them during the first
treatment cycle.
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 EMPLICITI infusion.
Infections
In the ELOQUENT-2 trial (N=635), infections were reported in 81%
of patients in the ERd arm and 74% in the Rd arm. Grade 3-4
infections were 28% (ERd) and 24% (Rd). Discontinuations due to
infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were
2.5% (ERd) and 2.2% (Rd). Opportunistic infections were reported in
22% (ERd) and 13% (Rd). Fungal infections were 10% (ERd) and 5%
(Rd). Herpes zoster was 14% (ERd) and 7% (Rd).
In the ELOQUENT-3 trial (N=115), infections were reported in 65%
of patients in both the EPd arm and the Pd arm. Grade 3-4
infections were reported in 13% (EPd) and 22% (Pd).
Discontinuations due to infections were 7% (EPd) and 5% (Pd). Fatal
infections were 5% (EPd) and 3.6% (Pd). Opportunistic infections
were reported in 10% (EPd) and 9% (Pd). Herpes zoster was reported
in 5% (EPd) and 1.8% (Pd).
Monitor patients for development of infections and treat
promptly.
Second Primary Malignancies
In the ELOQUENT-2 trial (N=635), invasive second primary
malignancies (SPM) were 9% (ERd) and 6% (Rd). The rate of
hematologic malignancies was 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).
In the ELOQUENT-3 trial (N=115), invasive SPMs were 0% (EPd) and
1.8% (Pd).
Monitor patients for the development of SPMs.
Hepatotoxicity
In the ELOQUENT-2 trial (N=635), AST/ALT >3X the upper limit,
total bilirubin >2X the upper limit, and alkaline phosphatase
<2X the upper limit were 2.5% (ERd) vs 0.6% (Rd). Of 8 patients
experiencing hepatotoxicity, 2 patients discontinued treatment
while 6 patients had resolution and continued. Monitor liver
enzymes periodically. Stop EMPLICITI upon ≥Grade 3 elevation of
liver enzymes. Continuation of treatment may be considered after
return to baseline values.
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 available data on EMPLICITI use in pregnant women
to inform a drug-associated risk of major birth defects and
miscarriage.
There is a risk of fetal harm, including severe life-threatening
human birth defects, associated with lenalidomide and pomalidomide,
and they are contraindicated for use in pregnancy. Refer to the
respective product 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
ELOQUENT-2 trial:
- Serious adverse reactions were 65% (ERd) and 57% (Rd). The most
frequent serious adverse reactions in the ERd arm compared to the
Rd arm were: pneumonia (15%, 11%), pyrexia (7%, 5%), 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 (62%, 52%), diarrhea (47%, 36%), pyrexia (37%,
25%), constipation (36%, 27%), cough (34%, 19%), peripheral
neuropathy (27%, 21%), nasopharyngitis (25%, 19%), upper
respiratory tract infection (23%, 17%), decreased appetite (21%,
13%), and pneumonia (20%, 14%).
ELOQUENT-3 trial:
- Serious adverse reactions were 22% (EPd) and 15% (Pd). The most
frequent serious adverse reactions in the EPd arm compared to the
Pd arm were: pneumonia (13%, 11%) and respiratory tract infection
(7%, 3.6%).
- The most common adverse reactions in EPd arm (≥20% EPd) and Pd,
respectively, were constipation (22%, 11%) and hyperglycemia (20%,
15%).
Please see the full Prescribing Information.
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 us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that
deliver transformational improvements in cancer treatment by
uniquely combining our deep knowledge in core areas of biology with
cutting-edge technologies, and by working together with our
partners – scientists, clinical experts, industry peers, advocates,
and patients. We remain focused on delivering these transformative
advances in treatment across some of the most debilitating and
widespread cancers. We are also committed to exploring solutions to
help patients obtain access to our cancer medicines. With the
acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our
research and development efforts, and through collaborations,
AbbVie's oncology portfolio now consists of marketed medicines and
a pipeline containing multiple new molecules being evaluated
worldwide in more than 200 clinical trials and more than 20
different tumor types. For more information, please visit
http://www.abbvie.com/oncology.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on historical performance and current expectations and
projections about our future financial results, goals, plans and
objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond our control and could cause
our future financial results, goals, plans and objectives to differ
materially from those expressed in, or implied by, the statements.
These risks, assumptions, uncertainties and other factors include,
among others, that Empliciti may not receive regulatory approval
for the additional indication described in this release and, if
approved, whether Empliciti for such additional indication
described in this release will be commercially successful. No
forward-looking statement can be guaranteed. Forward-looking
statements in this press release should be evaluated together with
the many risks and uncertainties that affect Bristol-Myers Squibb's
business and market, particularly those identified in the
cautionary statement and risk factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2018, as updated by our subsequent Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K and other filings with the Securities
and Exchange Commission. The forward-looking statements included in
this document are made only as of the date of this document and
except as otherwise required by applicable law, Bristol-Myers
Squibb undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.
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