Reblozyl, the first erythroid maturation
agent, met primary and key secondary endpoints in the first-line
treatment of patients with very low/low/intermediate-risk
myelodysplastic syndromes
Bristol Myers Squibb (NYSE: BMY) today announced the COMMANDS
study, a Phase 3, open-label, randomized trial evaluating Reblozyl®
(luspatercept-aamt), met its primary endpoint, demonstrating a
highly statistically significant and clinically meaningful
improvement in red blood cell transfusion independence (RBC-TI)
with concurrent hemoglobin (Hb) increase in the first-line
treatment of adult patients with very low-, low- or
intermediate-risk myelodysplastic syndromes (MDS) who require RBC
transfusions. This result was based on a pre-specified interim
analysis conducted through an independent review committee. Safety
results in the trial were consistent with the safety profile of
Reblozyl previously demonstrated in the MEDALIST study
(NCT02631070), and no new safety signals were reported.
“While advancements have been made in the treatment of anemia
for patients with myelodysplastic syndromes, there remains a
significant need for new and better first-line treatment options
for patients with transfusion-dependent MDS,” said Noah Berkowitz,
M.D., Ph.D., senior vice president, Hematology Development, Bristol
Myers Squibb. “We are pleased with the positive results of the
COMMANDS study and look forward to presenting these important
data.”
Bristol Myers Squibb will complete a full evaluation of the
COMMANDS data and work with investigators to present detailed
results at an upcoming medical meeting, as well as discuss these
results with health authorities. Bristol Myers Squibb thanks the
patients and investigators who are participating in the COMMANDS
clinical trial.
Reblozyl is being developed and commercialized through a global
collaboration with Merck following Merck’s acquisition of Acceleron
Pharma, Inc. in November 2021.
About COMMANDS
COMMANDS (NCT03682536) is a Phase 3, open-label, randomized
study evaluating the efficacy and safety of Reblozyl versus epoetin
alfa, for the treatment of anemia due to very low-, low- or
intermediate-risk (IPSS-R) myelodysplastic syndrome (MDS) in
patients who are red blood cell (RBC) transfusion dependent and
were erythropoiesis stimulating agent (ESA) naïve.
The primary endpoint evaluated in this study is RBC transfusion
independence (RBC-TI) for 12 weeks with a mean hemoglobin increase
≥1.5 g/dL. Key secondary endpoints include RBC-TI for 24 weeks,
RBC-TI ≥12 weeks and erythroid response of at least 8 weeks during
weeks 1-24 of the study.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of closely related
blood cancers characterized by ineffective production of healthy
red blood cells, white blood cells and platelets, which can lead to
anemia and frequent or severe infections.1,2 People with MDS who
develop anemia often require regular blood transfusions to increase
the number of healthy red blood cells in circulation.3 Frequent
transfusions are associated with an increased risk of iron
overload, transfusion reactions and infections.4
About Reblozyl®
(luspatercept-aamt)
Reblozyl, a first-in-class therapeutic option, promotes
late-stage red blood cell maturation in animal models.5 Reblozyl is
being developed and commercialized through a global collaboration
with Merck following Merck’s acquisition of Acceleron Pharma, Inc.
in November 2021. Reblozyl is currently approved in the U.S. for
the treatment of:
- anemia in adult patients with beta thalassemia who require
regular red blood cell transfusions, and
- anemia failing an erythropoiesis stimulating agent and
requiring 2 or more red blood cell units over 8 weeks in adult
patients with very low- to intermediate-risk myelodysplastic
syndrome with ring sideroblasts (MDS-RS) or with
myelodysplastic/myeloproliferative neoplasm with ring sideroblasts
and thrombocytosis (MDS/MPN-RS-T).
Reblozyl is not indicated for use as a substitute for red blood
cell transfusions in patients who require immediate correction of
anemia.
Important Safety Information
WARNINGS AND PRECAUTIONS
Thrombosis/Thromboembolism
In adult patients with beta thalassemia, thromboembolic events
(TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients.
TEEs included deep vein thrombosis, pulmonary embolus, portal vein
thrombosis, and ischemic stroke. Patients with known risk factors
for thromboembolism (splenectomy or concomitant use of hormone
replacement therapy) may be at further increased risk of
thromboembolic conditions. Consider thromboprophylaxis in patients
at increased risk of TEE. Monitor patients for signs and symptoms
of thromboembolic events and institute treatment promptly.
Hypertension
Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated
patients. Across clinical studies, the incidence of Grade 3 to 4
hypertension ranged from 1.8% to 8.6%. In patients with beta
thalassemia with normal baseline blood pressure, 13 (6.2%) patients
developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%)
patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In
adult patients with MDS with normal baseline blood pressure, 26
(29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients
developed DBP ≥80 mm Hg. Monitor blood pressure prior to each
administration. Manage new or exacerbations of preexisting
hypertension using anti-hypertensive agents.
Extramedullary Hematopoietic Masses
In adult patients with transfusion-dependent beta thalassemia,
EMH masses were observed in 3.2% of REBLOZYL-treated patients, with
spinal cord compression symptoms due to EMH masses occurring in
1.9% of patients (BELIEVE and REBLOZYL long-term follow-up
study).
In a study of adult patients with non-transfusion-dependent beta
thalassemia, a higher incidence of EMH masses was observed in 6.3%
of REBLOZYL-treated patients vs. 2% of placebo-treated patients in
the double- blind phase of the study, with spinal cord compression
due to EMH masses occurring in 1 patient with a prior history of
EMH. REBLOZYL is not indicated for use in patients with
non-transfusion-dependent beta thalassemia.
Possible risk factors for the development of EMH masses in
patients with beta thalassemia include history of EMH masses,
splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin
(<8.5 g/dL). Signs and symptoms may vary depending on the
anatomical location. Monitor patients with beta thalassemia at
initiation and during treatment for symptoms and signs or
complications resulting from the EMH masses and treat according to
clinical guidelines. Discontinue treatment with REBLOZYL in case of
serious complications due to EMH masses. Avoid use of REBLOZYL in
patients requiring treatment to control the growth of EMH
masses.
Embryo-Fetal Toxicity
REBLOZYL may cause fetal harm when administered to a pregnant
woman. REBLOZYL caused increased post- implantation loss, decreased
litter size, and an increased incidence of skeletal variations in
pregnant rat and rabbit studies. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential
to use effective contraception during treatment and for at least 3
months after the final dose.
ADVERSE REACTIONS
Beta Thalassemia
Serious adverse reactions occurred in 3.6% of patients on
REBLOZYL. Serious adverse reactions occurring in 1% of patients
included cerebrovascular accident and deep vein thrombosis. A fatal
adverse reaction occurred in 1 patient treated with REBLOZYL who
died due to an unconfirmed case of acute myeloid leukemia
(AML).
Most common adverse reactions (at least 10% for REBLOZYL and 1%
more than placebo) were headache (26% vs 24%), bone pain (20% vs
8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs
11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and
dizziness (11% vs 5%).
Myelodysplastic
Syndromes
Grade ≥3 (≥2%) adverse reactions included fatigue, hypertension,
syncope and musculoskeletal pain. A fatal adverse reaction occurred
in 5 (2.1%) patients.
The most common (≥10%) adverse reactions included fatigue,
musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity
reactions, hypertension, headache, upper respiratory tract
infection, bronchitis, and urinary tract infection.
LACTATION
It is not known whether REBLOZYL is excreted into human milk or
absorbed systemically after ingestion by a nursing infant. REBLOZYL
was detected in milk of lactating rats. When a drug is present in
animal milk, it is likely that the drug will be present in human
milk. Because many drugs are excreted in human milk, and because of
the unknown effects of REBLOZYL in infants, a decision should be
made whether to discontinue nursing or to discontinue treatment.
Because of the potential for serious adverse reactions in the
breastfed child, breastfeeding is not recommended during treatment
and for 3 months after the last dose.
Please see full Prescribing Information for REBLOZYL.
Bristol Myers Squibb: Creating a Better
Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision —
transforming people’s lives through science. The goal of the
company’s cancer research is to deliver medicines that offer each
patient a better, healthier life and to make cure a possibility.
Building on a legacy across a broad range of cancers that have
changed survival expectations for many, Bristol Myers Squibb
researchers are exploring new frontiers in personalized medicine,
and through innovative digital platforms, are turning data into
insights that sharpen their focus. Deep scientific expertise,
cutting-edge capabilities and discovery platforms enable the
company to look at cancer from every angle. Cancer can have a
relentless grasp on many parts of a patient’s life, and Bristol
Myers Squibb is committed to taking actions to address all aspects
of care, from diagnosis to survivorship. Because as a leader in
cancer care, Bristol Myers Squibb is working to empower all people
with cancer to have a better future.
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, Facebook and
Instagram.
Forward-Looking Statement of Bristol
Myers Squibb
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 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 future study results may not be consistent with the results to
date, that Reblozyl (luspatercept-aamt) may not receive regulatory
approval for the additional indication described in this release in
the currently anticipated timeline or at all, that any marketing
approvals, if granted, may have significant limitations on their
use, and, if approved, whether such product candidate 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, 2021, 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.
References:
- Mount Sinai. Myelodysplastic Syndrome. Available at:
https://www.mountsinai.org/care/cancer/services/mds. Accessed
September 2022.
- Myelodysplastic Syndromes Foundation. What is MDS? Available
at:
https://www.cancer.org/cancer/myelodysplastic-syndrome/about/what-is-mds.html.
Accessed September 2022.
- Johns Hopkins Medicine. Myelodysplastic Syndrome. Available at:
https://www.hopkinsmedicine.org/kimmel_cancer_center/types_cancer/myelodysplastic_syndrome.html.
Accessed September 2022.
- Rasel M, Mahboobi SK. Transfusion Iron Overload. PubMed. 2021.
Available at: https://www.ncbi.nlm.nih.gov/books/NBK562146/.
Accessed September 2022.
- Galanello R, Origa R. Beta thalassemia. Orphanet Journal of
Rare Diseases. 2010;5(11). Available at:
https://ojrd.biomedcentral.com/articles/10.1186/1750-1172-5-11.
Accessed September 2022.
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