The study evaluated the efficacy and safety of Reblozyl in treating anaemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndrome (MDS), versus epoetin alfa
Reblozyl is used for treating anaemia. (Credit: Narupon Promvichai from Pixabay)
US-based pharmaceutical company Bristol Myers Squibb has unveiled positive results for Reblozyl (luspatercept-aamt) from the Phase 3 COMMANDS trial.
The study evaluated the efficacy and safety of Reblozyl in treating anaemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndrome (MDS), versus epoetin alfa.
It recruited patients who are dependent on red blood cell (RBC) transfusion and were naïve to erythropoiesis-stimulating agent (ESA).
The Phase 3 trial has met the primary endpoint, showing a statistically significant and clinically meaningful improvement in red blood cell transfusion independence (RBC-TI) with an increase in haemoglobin (Hb) levels.
The study data was generated based on a pre-specified interim analysis conducted through an independent review committee, said the company.
Bristol Myers Squibb haematology development senior vice president Noah Berkowitz said: “While advancements have been made in the treatment of anaemia for patients with myelodysplastic syndromes, there remains a significant need for new and better first-line treatment options for patients with transfusion-dependent MDS.
“We are pleased with the positive results of the COMMANDS study and look forward to presenting these important data.”
Reblozyl is a recombinant fusion protein derived from human activin receptor type IIb (ActRIIb), used for the treatment of anaemia in beta-thalassemia and myelodysplastic syndromes.
The drug is being developed and commercialised through a global collaboration with Merck, following the latter’s acquisition of Acceleron Pharma, in November last year.
In the Phase 3 COMMANDS trial, Reblozyl showed a safety profile that was consistent with the safety profile of the dug in the MEDALIST study, with no new safety signals reported.
Reblozyl has been approved in the US and Canada to treat anaemia in adult patients with beta-thalassemia, who require regular red blood cell (RBC) transfusions.
Also, the drug is approved in Europe to treat transfusion-dependent anaemia in adults with myelodysplastic syndromes (MDS) with ring sideroblasts, and who are not eligible for erythropoietin-based therapy.
Bristol Myers said that it will complete a full evaluation of the COMMANDS data and work with investigators to present detailed results.