Bristol Myers Squibb’s Reblozyl misses primary endpoint in myelofibrosis trial

PRINCETON, N.J. - Bristol Myers Squibb (NYSE:BMY), a pharmaceutical giant with $47.6 billion in annual revenue and an impressive 74.7% gross profit margin, announced Friday that its Phase 3 INDEPENDENCE trial evaluating Reblozyl (luspatercept-aamt) in myelofibrosis-associated anemia did not meet its primary endpoint of red blood cell transfusion independence during any consecutive 12-week period.InvestingPro analysis reveals the company maintains strong financial health with multiple positive indicators. Subscribers can access 12 additional expert ProTips and comprehensive analysis through the Pro Research Report.

Despite missing statistical significance (p=0.0674), the company reported that patients receiving Reblozyl showed a numerical and clinically meaningful improvement in transfusion independence compared to placebo, consistent with previous Phase 2 results. The company’s robust financial position, with an "GREAT" Financial Health score according to InvestingPro, provides strong backing for its ongoing research and development efforts.

Several secondary measures demonstrated clinically meaningful benefits favoring Reblozyl, including a higher number of patients achieving at least a 50% reduction in red blood cell transfusion burden and more patients reaching hemoglobin level increases of at least 1 g/dL while remaining transfusion independent for at least 12 consecutive weeks.

The treatment’s safety profile remained consistent with previously reported data across indications, according to the company.

"We remain confident in the ability of Reblozyl to improve outcomes for patients with myelofibrosis-associated anemia," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology, and Cell Therapy for Bristol Myers Squibb.

Dr. John Mascarenhas, Professor of Medicine at the Icahn School of Medicine at Mount Sinai, noted that "patients with myelofibrosis and anemia are difficult to treat, and these results show that Reblozyl can have an important impact on anemia associated with the disease."

Bristol Myers Squibb stated it plans to engage with the FDA and EMA to discuss potential marketing applications based on the study results.

Reblozyl is currently approved for treating anemia in adult patients with beta thalassemia requiring regular red blood cell transfusions and for certain patients with myelodysplastic syndromes.

Myelofibrosis is a rare blood cancer characterized by bone marrow scarring that impairs normal blood cell production, often leading to anemia. The condition has an annual incidence of approximately 0.3 cases per 100,000 individuals in the U.S.

The information in this article is based on a press release statement from Bristol Myers Squibb.

In other recent news, Bristol Myers Squibb announced a new initiative with Pfizer to provide their anticoagulant medication, Eliquis, at a more than 40% discount for uninsured, underinsured, or self-pay patients. This program, launching September 8, aims to make the medication more affordable and accessible across the United States and Puerto Rico. UBS has maintained a Neutral rating on Bristol Myers Squibb, projecting second-quarter sales of $3.5 billion for Eliquis, indicating an 8% growth, while also noting potential impacts from Part D redesign on other high-priced drugs. Bristol Myers Squibb has declared a quarterly dividend of $0.62 per share on its common stock, continuing its consistent dividend payment schedule. The company also reported high response rates for its CAR T cell therapy, liso-cel, in treating relapsed or refractory marginal zone lymphoma, with a 95.5% patient response rate. Cantor Fitzgerald has also maintained a neutral rating, citing upcoming data for Bristol Myers Squibb’s Alzheimer’s treatment as a significant future catalyst. The firm noted the potential of Cobenfy to become a major revenue driver for the company, despite the challenges in predicting outcomes due to limited clinical data. These developments reflect ongoing efforts and challenges faced by Bristol Myers Squibb in both their product offerings and financial outlook.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.