Strong Phase III results for BMS' Reblozyl

New top-line data released this morning by US pharma major Bristol Myers Squibb (NYSE: BMY) suggest that its already-marketed drug Reblozyl (luspatercept-aamt) should be able to address a larger proportion of myelodysplastic syndromes (MDS) patients.

The New York-based company’s Phase III, open-label, randomized trial evaluating Reblozyl, the first erythroid maturation agent, met its primary endpoint, demonstrating a highly statistically-significant and clinically-meaningful improvement in red blood cell transfusion independence (RBC-TI) with concurrent hemoglobin (Hb) increase in the first-line treatment of adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes who require RBC transfusions.

This result was based on a pre-specified interim analysis conducted through an independent review committee. Safety results in the trial were consistent with the safety profile of Reblozyl previously demonstrated in the MEDALIST study (NCT02631070), and no new safety signals were reported.