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BMS’s Reblozyl meets primary endpoint in myelodysplastic syndromes phase 3 trial

The study showed significant improvements in red blood cell transfusion independence

BMS

Bristol Myers Squibb (BMS) has announced positive topline results from a phase 3 trial evaluating Reblozyl (luspatercept-aamt) as a first-line treatment in patients with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) who require red blood cell transfusions.

MDS are a group of closely related blood cancers characterised by ineffective production of healthy red blood cells, white blood cells and platelets, which can lead to anaemia and frequent or severe infections.

Patients with MDS who develop anaemia often require regular blood transfusions to increase the number of healthy red blood cells in circulation, but frequent transfusions are often associated with an increased risk of iron overload, transfusion reactions and infections.

COMMAND is a phase 3, open-label, randomised trial evaluating the efficacy and safety of Reblozyl versus epoetin alfa. The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in red blood cell transfusion independence with concurrent haemoglobin increase.

Safety results in the trial were consistent with the safety profile of Reblozyl previously demonstrated in the MEDALIST study, the company said, and no new safety signals were reported.

Commenting on the positive results, Noah Berkowitz, senior vice president, haematology development, BMS, 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.”

The company said it is planning to complete a full evaluation of the COMMANDS data and present detailed results at an upcoming medical meeting, as well as discuss the results with health authorities.

“We are pleased with the positive results of the COMMANDS study and look forward to presenting this important data,” Berkowitz said.

Reblozyl is being developed and commercialised through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma in November 2021.

The treatment is currently approved in the US for anaemia in adult patients with beta thalassaemia who require regular red blood cell transfusions, as well as for the treatment of anaemia failing an erythropoiesis stimulating agent and requiring two or more red blood cell units over eight weeks in adult patients with very low- to intermediate-risk MDS with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.

Article by
Emily Kimber

1st November 2022

From: Research

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