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Bristol Myers Squibb Announces Positive Results for Luspatercept in Alpha-Thalassemia
Reblozyl meets primary and secondary endpoints in Phase 2 study for both non-transfusion-dependent and transfusion-dependent cohorts.
Published on Feb. 23, 2026
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Bristol Myers Squibb announced positive top-line results from a Phase 2 registrational study evaluating Reblozyl (luspatercept-aamt) versus placebo for anemia in adults with Alpha (α)-Thalassemia. The non-transfusion-dependent and transfusion-dependent cohorts of the study met their respective primary endpoints, with Reblozyl demonstrating statistically significant and clinically meaningful improvements. The data will be presented at an upcoming medical congress and discussed with Chinese regulators.
Why it matters
These results further support the potential of Reblozyl to address the significant unmet medical needs of patients with alpha-Thalassemia, a rare and serious genetic blood disorder that can lead to severe anemia and other life-threatening complications. Reblozyl is the first and only therapy specifically designed to address alpha-Thalassemia, which is especially prevalent in China.
The details
The Phase 2 trial evaluated the efficacy and safety of luspatercept plus best supportive care versus placebo in adults and adolescents with α-thalassemia, including both red blood cell (RBC) transfusion-dependent (TD) and non-transfusion-dependent (NTD) cohorts. The NTD cohort met its primary endpoint of a ≥1 g/dL increase in mean hemoglobin levels over 12 weeks, while the TD cohort met its primary endpoint of a ≥50% reduction in RBC transfusion burden. The study also met all key secondary endpoints, and the safety profile was consistent with Reblozyl's known safety in thalassemia.
- The Phase 2 trial is an ongoing, ex-US study (NCT05664737).
- The data will be presented at an upcoming medical congress.
- Bristol Myers Squibb will discuss the results with the Center for Drug Evaluation in China.
The players
Bristol Myers Squibb
A global biopharmaceutical company that is developing and commercializing Reblozyl, a first-in-class therapeutic option for treating anemia in patients with thalassemia and myelodysplastic syndromes.
Reblozyl
A medication that promotes late-stage red blood cell maturation and is indicated for the treatment of anemia in adult patients with beta thalassemia, myelodysplastic syndromes, and other conditions.
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb.
What they’re saying
“These positive data further support the potential of Reblozyl for patients around the world.”
— Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development (Bristol Myers Squibb)
What’s next
The data will be presented at an upcoming medical congress and discussed with the Center for Drug Evaluation in China.
The takeaway
The positive results from this Phase 2 study demonstrate the potential of Reblozyl to address the significant unmet medical needs of patients with alpha-Thalassemia, a rare and serious genetic blood disorder that can lead to severe anemia and other life-threatening complications. This is an important step forward in developing new treatment options for this underserved patient population, particularly in China where the disease is more prevalent.
