BMS announces positive Reblozyl phase 3 results for MDS

Bristol Myers Squibb has announced positive topline results from its phase 3 trial of Reblozyl (luspatercept-aamt), the first erythroid maturation agent for first-line treatment of patients with very low-, low-, and intermediate-risk (IPSS-R) myelodyplastic syndromes (MDS), having met primary and key secondary endpoints.

The COMMANDS study (NCT03682536) - a phase 3 open-label, randomised trial to evaluate the efficacy and safety of Reblozyl versus epoetin alfa - demonstrated high statistical significance and clinically meaningful improvement in red blood cell transfusion independence (RBC-TI) with concurrent haemoglobin (Hb) increase, when used as first-line treatment of adult patients with IPSS-R MDS requiring RBC transfusions, and who were erythropoiesis stimulating agent (ESA) naïve.

The results were based on pre-specified interim analysis conducted through an independent review committee and safety results were consistent with the safety profile previously demonstrated by Reblozyl in the MEDALIST study (NCT02631070). The primary endpoint was RBC-TI for 12 weeks, with secondary endpoints including RBC-TI at 24 weeks and erythroid response of at least eight weeks during weeks one to 24 of the study.

MDS are a group of closely related blood cancers in which there is ineffective production of healthy red blood cells, white blood cells, and platelets. This can lead to anaemia and frequent or severe infections. Those patients with MDS who develop anaemia often require regular blood transfusions in order to increase the number of healthy red blood cells in their circulation system. However, frequent transfusions are associated with an increased risk of iron overload, transfusion reactions, and infections in themselves.

A full evaluation of the COMMANDS data is yet to be undertaken by BMS, and the company will work with investigators in order to present detailed results at an upcoming medical meeting and discussions with health authorities.

Dr Noah Berkowitz, senior vice president, haematology department at Bristol Myers Squibb, said: “While advancements have been made in the treatment of anaemia for patients with myelodyplastic syndromes, there remains a significant need for new and better first-line treatment options for patients with transfusions-dependent MDS.”

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

Reblozyl is currently approved in the US for the treatment of anaemia in adult patients with beta thalassemia requiring regular RBC transfusions, as well as in anaemia failing an erythropoiesis stimulating agent that requires two or more RBC units over eight week in adult patients with IPSS-R myelodyplastic syndrome with ring sideroblasts (MDS-RS) or myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MPN-RS-T).