BMS and MSD’s Reblozyl Falls Short of Primary Goal in Myelofibrosis Anaemia Trial

Bristol Myers Squibb (BMS) announced that the Phase III INDEPENDENCE trial of Reblozyl (luspatercept-aamt) combined with a Janus kinase inhibitor (JAKi) did not meet its primary endpoint—achieving red blood cell (RBC) transfusion independence in adults with myelofibrosis-associated anaemia. Despite this, the therapy showed clinically meaningful benefits, including reduced transfusion burden and improved haemoglobin levels. These secondary outcomes align with earlier Phase II results. The safety profile was consistent with previous findings. BMS, in partnership with MSD (following MSD’s $11.5bn acquisition of Acceleron Pharma in 2021), plans to engage regulators, including the FDA and EMA, to explore potential approval pathways. Reblozyl is already approved for anaemia linked to myelodysplastic syndromes and beta thalassemia. BMS remains optimistic that the therapy could help address unmet needs in patients with limited treatment options for myelofibrosis-associated anaemia.

21-07-2025