22 THE QUEENS COURIER • JANUARY 30, 2020 FOR BREAKING NEWS VISIT WWW.QNS.COM
Long-term progression-free survival data in multiple myeloma
Multiple myeloma is one of
the most common types of
blood cancer, with more than
30,000 Americans expected to
be diagnosed this year.Formed
by malignant plasma cells that
are typically located within bone
marrow, multiple myeloma oft en
causes no symptoms until an
advanced stage. Despite advances
in treatment over the last
decade, less than half of patients
survive longer than fi ve years
aft er diagnosis.
There have been numerous
advancements in multiple
myeloma research and treatment
options that have improved the
overall prognosis of the disease.
Some of these advancements
involve exploring potential ways
to work directly with patients’
immune systems to fi ght multiple
myeloma, an area of research
known as Immuno-Oncology
(I-O).
Recently, research looking at
follow-up data for relapsed or
refractory multiple myeloma
I-O treatment, Empliciti™ (elotuzumab),
was presented at the
22nd Congress of the European
Hematology Association.
Empliciti is a prescription medicine
used to treat multiple
myeloma in combination with
the medicines lenalidomide
and dexamethasone in people
who have received one to three
prior treatments for their multiple
myeloma. It is not known
if Empliciti is safe and eff ective
in children.
Empliciti in combination
with lenalidomide and dexamethasone
may cause the following
serious side eff ects: infusion
reactions, infections, risk of
developing new cancers (malignancies)
and liver problems.
Th ere are also other serious
risks associated with lenalidomide
to females and males of
reproductive potential, including
possible serious birth defects or
death of an unborn baby, and
specifi c requirements regarding
birth control, pregnancy testing
and blood and/or sperm donation.
For more information,
please read Important Safety
Information below. Patients’
healthcare team will work with
them to manage any side eff ects
they may experience throughout
treatment with Empliciti.
In the clinical trial of 646 multiple
myeloma patients who had
received one to three prior treatments
(in which 321 received
Empliciti with lenalidomide
and dexamethasone, and 325
received lenalidomide and dexamethasone
alone), more people
in the Empliciti treatment arm
were living with their disease
under control aft er four years of
follow-up.
Empliciti, in combination
with lenalidomide and dexamethasone
in patients who had
received one to three prior therapies,
is the only therapy that
demonstrated a long-term benefi
t in progression-free survival
that was maintained through
four years versus lenalidomide
and dexamethasone alone.
Aft er at least two years of follow
up, people who received
Empliciti with lenalidomide and
dexamethasone were at 30 percent
less risk of their disease progressing
or passing away from
any cause, compared with people
taking lenalidomide and dexamethasone
alone. Aft er at least
four years of follow-up, results
were similar.
At the four-year follow-up,
there was a 21 percent chance
that people taking Empliciti with
lenalidomide and dexamethasone
were still living with their
disease under control, compared
with a 14 percent chance for
people taking lenalidomide and
dexamethasone alone.
Th e study was designed to look
at progression-free survival at
two years. Progression-free survival
is the length of time during
and aft er treatment of a disease
that a patient lives with the disease,
but it does not get worse.
Th e study was also designed to
look at the overall response rate.
Overall response rate is the percentage
of patients who responded
to treatment-for example,
patients whose level of M protein
was lowered by a certain
amount. Overall response rates
include complete response, very
good partial response and partial
response.
Th e main analysis for progression
free survival took place at
two years. Patients still benefi ting
from treatment continued in the
study, and a follow-up analysis
was done at four years. Both evaluations
were based on the entire
population of 646 patients.
At two years, there was a 41
percent chance that people taking
Empliciti with lenalidomide and
dexamethasone were living with
their disease under control, compared
with a 27 percent chance
for people taking lenalidomide
and dexamethasone alone.
Also in this study, about four
out of fi ve people (78.5 percent)
responded to treatment with
Empliciti with lenalidomide and
dexamethasone, compared to
about two out of three people
(65.5 percent) taking lenalidomide
and dexamethasone alone.
Th e most common side eff ects
of Empliciti in combination with
lenalidomide and dexamethasone
and lenalidomide and dexamethasone
alone, respectively,
were fatigue (61.6 percent, 51.7
percent); diarrhea (46.9 percent,
36.0 percent); fever (37.4 percent,
24.6 percent); constipation (35.5
percent, 27.1 percent); cough
(34.3 percent, 18.9 percent);
numbness, weakness, tingling, or
burning pain in your arms or legs
(26.7 percent, 20.8 percent); sore
throat or runny nose (24.5 percent,
19.2 percent); upper respiratory
tract infection (22.6 percent,
17.4 percent); decreased
appetite (20.8 percent, 12.6 percent);
and pneumonia (20.1 percent,
14.2 percent).
Th ese side eff ect rates were
determined aft er the typical
patient had received about 19
cycles of Empliciti with lenalidomide
and dexamethasone or
14 cycles of lenalidomide and
dexamethasone alone. These
side eff ects were experienced by
at least 20 percent of patients
receiving Empliciti with lenalidomide
and dexamethasone and
at a 5 percent or greater rate than
patients who took lenalidomide
and dexamethasone alone.
Th e percentage of patients
who stopped treatment due
to side eff ects was similar for
both treatment groups (6.0 percent
for patients who received
Empliciti with lenalidomide and
dexamethasone and 6.3 percent
for patients who received lenalidomide
and dexamethasone
alone).6
Researchers across the globe
are continuing research into activating
the body’s immune system
to fi ght cancers, both hematologic
and solid tumors, with the goal
of providing more eff ective treatment
options. Th e results of this
follow-up analysis are an important
step toward progress in supporting
relapsed or refractory
multiple myeloma patients.6
Empliciti is available by prescription
only in 300 mg and 400
mg vials for injection for intravenous
use. Empliciti may not
work for all patients, and individual
results may vary.
— Courtesy BPT
top doctors 2020
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