Brukinsa shows lasting benefit in CLL/SLL patients 80 and older
Nearly two-thirds were progression-free at 6 years in SEQUOIA analysis
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Nearly two-thirds of adults ages 80 and older with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), two related types of blood cancer, who were treated with Brukinsa (zanubrutinib), remained progression-free at six years.
Those are the results from an older-patient subgroup analysis of the SEQUOIA Phase 3 clinical trial (NCT03336333), which enrolled 590 adults with previously untreated CLL/SLL and includes a comparison of Brukinsa versus bendamustine (sold as Bendeka and others) plus rituximab (sold as Rituxan, among others).
Older patients often left out of CLL trials
“These data show that the durable benefit of Brukinsa extends to patients in their 80s, including those with high-risk features,” Amit Agarwal, MD, PhD, chief medical officer of hematology at BeOne Medicines, the therapy’s developer, said in a company press release.
BeOne presented the new data at the 2026 European Hematology Association (EHA) Congress, held this month in Stockholm, Sweden.
CLL, a type of blood cancer in which the bone marrow produces too many abnormal white blood cells, primarily affects older people. CLL and SLL are considered different forms of the same disease, with the main difference being where the cancer cells are primarily located in the body.
About 69% of new cases occur in people aged 65 or older, and 36% in those aged 75 or older. However, individuals over the age of 80 have historically been underrepresented in major CLL trials, leaving physicians with limited evidence to guide treatment decisions in this age group.
“While the median age of diagnosis for CLL is 70 and the average age of treatment initiation is 75, many pivotal trials still underrepresent the patients that physicians most often see in practice,” Agarwal said.
Moreover, a study of CLL patients found that one in three (32%) had cardiovascular disease, and most of those patients had three or more different cardiovascular conditions.
Brukinsa benefit seen in patients 80 and older
The new analysis drew on data from 38 CLL patients ages 80 to 87. Roughly 37% had genetic abnormalities known as del(17p) and/or TP53 mutation, which are associated with more aggressive disease and poorer outcomes. Nearly 58% had unmutated IGHV, another marker linked to a more challenging disease course.
After a median follow-up of 78.8 months (just over 6.5 years), the overall response rate was 100%, with 18.4% achieving a complete response, generally meaning that standard clinical measures no longer showed signs of active cancer. At 72 months (six years), 63.8% of patients remained progression-free, and 75.9% were still alive. At the time of the analysis, 36.8% of patients were still actively receiving Brukinsa.
“Treating CLL in patients in their 80s involves many considerations, as they often have other underlying health conditions and there has been little long-term evidence in this population to guide us,” said Alessandra Tedeschi, MD, PhD, at the Niguarda Cancer Center in Milan, Italy. “What stands out with this analysis from SEQUOIA is the durability we saw in elderly patients treated with [Brukinsa], including in patients with high-risk features, as well as the manageable safety profile. Together, these results give physicians additional long-term data to draw on when treating this population.”
The company also presented the full 78-month SEQUOIA data set, which included a comparison of Brukinsa with bendamustine-rituximab (BR). At 78 months, more than twice as many Brukinsa-treated patients remained progression-free as those who received BR (71.8% vs. 31.0%). When adjusted for the impact of COVID-19 on the study, those figures were 74.6% and 31.4%, respectively.
Longer follow-up favors Brukinsa over BR
In a subgroup analysis, estimated progression-free survival — the percentage of patients alive without disease progression — at 78 months was more than four times higher in the Brukinsa group than the BR group among patients with unmutated IGHV (70.4% vs. 17.4%). Among those with mutated IGHV, it was 81.8% versus 45.1%. Of the Brukinsa-treated patients whose disease progressed, half received a BCL2 inhibitor-based follow-up treatment, and most (69.2%) of those had not progressed after more than three years of additional follow-up.
BeOne presented additional data from several large real-world analyses. One study included 10,523 Medicare patients with CLL treated with a BTK inhibitor as first-line therapy. Brukinsa treatment was associated with a significantly lower adjusted risk of death, starting a next line of therapy, or discontinuing therapy compared with ibrutinib or acalabrutinib, two other BTK inhibitors approved for CLL/SLL. Similar results were seen across age subgroups.
A separate analysis of data from 16,788 patients with treatment-naive CLL found that Brukinsa was associated with a longer time to next treatment and longer overall survival compared with acalabrutinib.
In a third study of 233,362 newly diagnosed CLL patients, exploratory analyses among those who started first-line treatment with a BTK inhibitor found that the one-year rate of atrial fibrillation (an irregular heart rhythm and a known side effect with this class of drugs) was lowest for Brukinsa at 11%, compared with 13% for acalabrutinib and 16% for ibrutinib. This is relevant because the risk of atrial fibrillation increases with age and is further elevated in people with CLL.
“The consistently low rates of atrial fibrillation observed with BRUKINSA across clinical trials and real-world evidence reinforce its favorable tolerability profile in an older population, providing important confidence in first-line treatment decisions and supporting its role as the foundational BTK inhibitor in CLL,” Agarwal noted.
Online posts show what patients value most
BeOne also reported results from a patient preference study conducted across five European countries: France, Germany, Italy, Spain, and the U.K. Using an AI-based analysis of 44,451 online messages from 2,699 people posting about CLL, researchers identified the most commonly cited factors in online conversations about treatment decisions.
Safety was most frequently mentioned, appearing in 22% to 42% of conversations, followed by clinical profile or disease severity (9% to 25%) and effectiveness (11% to 15%). People posting online described effectiveness in terms of observable results, such as remission, how quickly the treatment worked, and whether it allowed them to return to normal daily life. Notably, how long a patient remains on treatment was among the least frequently mentioned factors, appearing in fewer than 5% of conversations across every country.
The study also found that treatment decisions were generally led by hematologists, who are specialists in blood disorders, with shared decision-making between patients and their doctors remaining limited. Overall, 7% of people posting online in the U.K. and 11% of those posting online in Germany reported being involved in their own treatment decisions.
“These findings reinforce the importance of treatment conversations aligned with what patients report valuing the most — efficacy, safety, and shared decision-making — when navigating first-line CLL care,” BeOne stated in its release.
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