BeiGene's Brukinsa Sets New Bar with Landmark 6-Year Cancer Data
Drug shows 74% of untreated leukemia patients remain progression-free, bolstering its market-leading position against key rivals from AbbVie and AstraZeneca.
BeiGene Ltd. (NASDAQ: BGNE) unveiled compelling long-term data for its cancer therapy Brukinsa, demonstrating a significant and sustained benefit for leukemia patients that reinforces the drug's growing dominance in a competitive market. In a six-year follow-up study, 74% of previously untreated chronic lymphocytic leukemia (CLL) patients taking Brukinsa remained alive and disease-free, a landmark result presented at the 2025 American Society of Hematology (ASH) Annual Meeting.
The data comes from the Phase 3 SEQUOIA study, a head-to-head trial that has been crucial in establishing Brukinsa's clinical credentials. The results showed that Brukinsa (zanubrutinib) reduced the risk of disease progression or death by a striking 72% compared to a standard chemoimmunotherapy combination of bendamustine and rituximab. The six-year progression-free survival (PFS) rate of 74% for Brukinsa stands in sharp contrast to the 32% rate observed in the control arm.
This robust, long-term evidence is critical for BeiGene as it battles for market share in the lucrative BTK inhibitor class of drugs, a market projected to exceed $21 billion by the early 2030s. Brukinsa's primary competitors are AbbVie and Johnson & Johnson's first-to-market Imbruvica (ibrutinib) and AstraZeneca's Calquence (acalabrutinib). While Imbruvica pioneered the class, Brukinsa has been systematically building a case for superior efficacy and a better safety profile, particularly regarding cardiovascular side effects.
The new long-term data validates a commercial strategy that is already bearing fruit. According to company reports from earlier in the year, Brukinsa has already surpassed its rivals to become the U.S. market share leader for new CLL patient starts across all lines of therapy. It also recently eclipsed AstraZeneca’s Calquence in quarterly sales, signaling a significant shift in a market once dominated by established players.
"Demonstrating sustained efficacy over six years is a high bar in oncology and provides a great deal of confidence to physicians and patients," said Dr. Mehrdad Mobasher, Chief Medical Officer, Hematology at BeiGene, in a statement accompanying the data release. The safety profile remained consistent with prior findings, with no new concerns emerging during the extended follow-up period.
Wall Street has maintained a bullish outlook on the company, anticipating continued growth driven by Brukinsa. In recent months, analysts at J.P. Morgan and TD COWEN have reiterated "Buy" ratings, with price targets of $235 and $260, respectively, citing the drug's strong momentum and expanding global footprint. The latest data is likely to strengthen this conviction.
The clinical and commercial success comes as the company itself is undergoing a transformation. BeiGene has announced it will be renamed BeOne Medicines Ltd., with its Nasdaq ticker symbol changing from BGNE to ONC, effective January 2, 2026. This rebranding reflects the company's evolution into a global, commercial-stage oncology leader.
With best-in-class long-term data for newly diagnosed CLL patients, a leading share of new prescriptions in the U.S., and strong momentum in global markets, Brukinsa is solidifying its position as a cornerstone therapy. The latest findings from the SEQUOIA trial provide a powerful new weapon in its arsenal as BeOne Medicines prepares for its next phase of growth.