BeOne Medicines Ltd. disclosed that its flagship BTK inhibitor BRUKINSA achieved a 74% progression‑free survival rate at six years in treatment‑naïve chronic lymphocytic leukemia (CLL) patients, the longest‑term follow‑up reported to date. The data, presented at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, confirm the durability of BRUKINSA’s clinical benefit and reinforce its position as a leading BTK inhibitor in the United States.
The six‑year PFS rate of 74% is markedly higher than the 32% observed with bendamustine‑rituximab (BR) in the same patient population, underscoring BRUKINSA’s superior efficacy. In addition, the overall survival (OS) rate at 72 months was 84% for BRUKINSA versus 80% for BR, further highlighting the drug’s long‑term benefit. These results were derived from the SEQUOIA trial, a pivotal study that has now provided the most extended evidence of BRUKINSA’s performance in treatment‑naïve CLL.
Chief Medical Officer Amit Agarwal, M.D., Ph.D., emphasized that the data “continue to deliver the high levels of durable progression‑free and overall survival that patients and physicians should demand from a BTK inhibitor.” He added that the findings support BeOne’s regulatory strategy and could accelerate future approvals, potentially expanding BRUKINSA’s market share in CLL and related B‑cell malignancies.
The ASH presentation also highlighted additional pipeline assets, including the BTK degrader BGB‑16673 and the BCL2 inhibitor sonrotoclax. These developments signal BeOne’s broader strategy to innovate across B‑cell cancers beyond BRUKINSA, positioning the company to capture multiple therapeutic opportunities as the market evolves.
Financially, BeOne reported a 54.96% revenue increase to $3.81 billion in 2024, although the company recorded a loss of $644.79 million. The robust clinical data reinforce investor confidence in the company’s growth trajectory and support its ongoing investment in pipeline candidates.
Overall, the six‑year PFS milestone strengthens BRUKINSA’s competitive advantage, validates its long‑term efficacy, and provides a solid foundation for future regulatory and commercial initiatives. The data are expected to enhance BeOne’s market positioning and accelerate the expansion of its product portfolio in B‑cell malignancies.
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