Squibb Company (NYSE:BMY) today announced that the ELOQUENT-3 trial,
an international Phase 2 study evaluating the addition of Empliciti (elotuzumab)
to pomalidomide and low-dose dexamethasone (EPd) in patients with
relapsed/refractory multiple myeloma (RRMM), achieved its primary
endpoint, showing a statistically significant and clinically meaningful
improvement in progression-free survival (PFS) for patients treated with
EPd compared with pomalidomide and dexamethasone (Pd) alone. ELOQUENT-3
is the only randomized, active-controlled trial to investigate a
pomalidomide-based triplet combination in patients with RRMM who
received at least two prior therapies, including lenalidomide and a
proteasome inhibitor (PI).
Patients randomized to EPd experienced a 46% reduction in risk of
disease progression (HR 0.54; 95% CI: 0.34 to 0.86, p=0.0078) compared
with patients randomized to Pd alone, with median PFS, the study’s
primary endpoint, of 10.3 months (95% CI: 5.6 to not estimable) compared
with 4.7 months (95% CI: 2.8 to 7.2) in Pd patients. The PFS benefit
experienced among patients randomized to EPd was consistent among
patients who had received two to three prior lines of therapy (HR 0.55;
95% CI: 0.31 to 0.98) and four or more prior lines of therapy (HR 0.51;
CI 95%: 0.24 to 1.08). The safety profile for EPd was consistent with
prior findings for Empliciti and pomalidomide regimens. The full
results will be presented in a late-breaking oral session on Sunday,
June 17, at 12:30 CEST during the 23rd Congress of the
European Hematology Association in Stockholm, Sweden.
“The ELOQUENT-3 trial is the first randomized trial comparing the
standard of care, pomalidomide and low dose dexamethasone, with and
without the addition of a monoclonal antibody. These data support the
hypothesis that the addition of elotuzumab to pomalidomide and
dexamethasone elicits a synergistic effect and prolongs, significantly,
the progression-free survival of heavily pretreated patients with
myeloma, regardless of the number of prior therapies,” said Meletios A.
Dimopoulos, M.D., professor and chairman of the Department of Clinical
Therapeutics at the National and Kapodistrian University of Athens,
School of Medicine. “We believe that EPd, if approved by regulatory
authorities, could become an important potential treatment option for
patients with relapsed/refractory multiple myeloma whose disease has
progressed after treatment with lenalidomide and a proteasome inhibitor.”
Twice as many patients randomized to EPd responded to therapy compared
to patients randomized to Pd alone. Patients randomized to EPd
demonstrated an overall response rate (ORR) of 53% (95% CI: 40 to 66),
compared with 26% (95% CI: 16 to 40) among patients randomized to Pd.
Time to first response was comparable for patients receiving EPd and Pd
at 1.95 and 1.91 months, respectively. Median duration of response had
not been reached among patients randomized to EPd at time of analysis.
Overall survival, a secondary endpoint, although not mature at this
time, showed a positive trend favoring EPd over Pd alone (HR 0.62; 95%
CI: 0.30 to 1.28).
“Based on survival data we’ve seen to date in relapsed or refractory
multiple myeloma, Empliciti in combination with lenalidomide and
dexamethasone has been established as an important treatment option for
patients,” said Jeffrey Jackson, Ph.D., hematology development lead,
Bristol-Myers Squibb. “These new data evaluating the EPd combination
build on our commitment to understanding the full potential of Empliciti
when used in different combinations. We look forward to discussing
these data with health authorities.”
Treatment-related Grade 3-4 adverse events (AEs) were comparable between
EPd and Pd groups. Any-grade infections occurred in 65% of patients in
both arms. Rates of the most commonly occurring Grade 3-4 hematologic
AEs, neutropenia and anemia, were lower among patients receiving EPd
(13% and 10%, respectively) than patients receiving Pd (27% and 20%),
despite longer exposure within the EPd arm and similar dose intensity of
pomalidomide between arms. AEs led to discontinuation in 18% of patients
in the EPd arm, compared with 24% of patients in the Pd arm.
The Phase 2 ELOQUENT-3 trial randomized 117 patients with RRMM 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 (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,
elotuzumab was administered at the dose of 10 mg/kg IV weekly for the
first 2 cycles and 20 mg/kg monthly starting from cycle 3.
Bristol-Myers Squibb & Immuno-Oncology:
Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do.
Our vision for the future of cancer care is focused on researching and
developing transformational medicines, including Immuno-Oncology (I-O)
therapeutic approaches, for hard-to-treat cancers that could potentially
improve outcomes for these patients.
We are leading the integrated scientific understanding of both tumor
cell and immune system pathways, through our extensive portfolio of
investigational compounds and approved agents. Our differentiated
clinical development program is studying broad patient populations
across more than 50 types of cancers with 24 clinical-stage molecules
designed to target different immune system pathways. Our deep expertise
and innovative clinical trial designs position us to advance the
I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation
therapies across multiple tumors and potentially deliver the next wave
of therapies with a sense of urgency. We also continue to pioneer
research that will help facilitate a deeper understanding of the role of
immune biomarkers and how a patient’s tumor biology can be used as a
guide for treatment decisions throughout their journey.
We understand making the promise of transformational medicines like I-O
therapies a reality for the many patients who may benefit from these
therapies requires not only innovation on our part but also close
collaboration with leading experts in the field. Our partnerships with
academia, government, advocacy and biotech companies support our
collective goal of providing new treatment options to advance the
standards of clinical practice.
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
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
Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with
Bristol-Myers Squibb solely responsible for commercial activities.
U.S. FDA-APPROVED INDICATION FOR EMPLICITI™
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
Second Primary Malignancies
Interference with Determination of Complete Response
Pregnancy/Females and Males of Reproductive Potential
Please see the full Prescribing Information for EMPLICITI.
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
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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.
Among other risks, there can be no guarantee that Empliciti will receive
regulatory approval for the indications described herein.
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, 2017 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.
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