Express Significantly improves anemia symptoms! BMS innovative therapies reached the primary clinical endpoint of Phase 3

Today, Bristol-Myers Squibb (BMS) announced that its red blood cell maturation agent Reblozyl (luspatercept) has reached its primary endpoint in a Phase 3 clinical trial
.
Data analysis showed that Reblozyl, as a first-line therapy, achieved statistical and clinical improvement in red blood cell transfusion independence (RBC-TI) and increased
hemoglobin (Hb) levels in patients with very low, low or moderate risk adult myelodysplastic syndrome (MDS) who require red blood cell transfusion.

MDS is a rare blood cancer that gradually affects the ability of the patient's bone marrow to produce normal blood cells and cannot effectively produce healthy red blood cells, white blood cells and platelets, resulting in symptoms
such as weakness, frequent infections, anemia and fatigue.
Patients with MDS who develop anemia often require regular blood transfusions to increase the number of
healthy red blood cells circulating.
Frequent blood transfusions are associated
with an increased risk of iron overload, transfusion reactions, and infection.
In some cases, MDS will progress to acute myeloid leukemia (AML).

MDS is classified
from very low to very high risk based on bone marrow composition, blood count, and chromosomal changes.

Reblozyl (Chinese trade name: Liblozæl) is a drug
that reduces the burden of blood transfusion by regulating the maturation process of red blood cells in the later stages.
As a soluble fusion protein, the drug is formed
by fusing the Fc domain of human immunoglobulin G1 (IgG1) with the extracellular domain of the activator receptor IIB (ActRIIB).
It acts as a ligand trap for TGF-β, preventing TGF-β from activating the Smad2/3 signaling pathway, thereby promoting the differentiation and maturation of advanced red blood cells, thereby reducing the burden
of regular red blood cell transfusions in patients.
Reblozyl was first approved in November 2019 for the treatment of anemia in adults β with thalassaemia who require regular red blood cell transfusions
.

The COMMANDS trial is a randomized, open-label phase 3 clinical trial to examine the efficacy and safety
of Reblozyl compared with hemothropoiesis stimulants in the treatment of anemia symptoms in patients with very low, low or moderate risk MDS.
These patients are dependent on red blood cell transfusions and have not received hemocyte-producing stimulants (ESAs
).
The primary endpoint of the trial was to maintain 12-week independence of red blood cell transfusion and achieve an increase
in mean hemoglobin levels ≥ 1.
5 g/dL.
Key secondary endpoints were maintaining red blood cell transfusion independence for 24 weeks, maintaining red blood cell transfusion independence for ≥ 12 weeks, and erythroid response at least 8 weeks at weeks to 24 of the trial
.
The scheduled interim analysis showed that the trial met the primary endpoint and that Reblozyl demonstrated safety consistent with previous trials, with no new safety issues
identified.

"While many therapies have been developed to improve anaemia in MDS patients, there is still a great need for new and better first-line therapies for MDS patients who rely on infusion," said Noah Berkowitz, Ph.
D
.
, Senior Vice President, Hematology Development, BMS.
”