Glossary:
ECOG Status: a way of scoring a patient’s ability to complete daily tasks, with a lower score meaning greater independence.
Neutropenia: a low count of neutrophils, a type of white blood cell.
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Brukinsa Shows Favorable Safety Profile Over Imbruvica in CLL
February 21, 2025
Alex Biese
Alex Biese
A nationally-published, award-winning journalist, Alex Biese joined the CURE team as an assistant managing editor in April 2023. Prior to that, Alex's work was published in outlets including the Chicago Sun-Times, MTV.com, USA TODAY and the Press of Atlantic City. Alex is a member of NLGJA: The Association of LGBTQ+ Journalists, and also performs at the Jersey Shore with the acoustic jam band Somewhat Relative.
Researchers have found Brukinsa to be a potentially safer alternative for patients with chronic lymphocytic leukemia.
Among patients with chronic lymphocytic leukemia (CLL), Brukinsa (zanubrutinib) has been found by researchers to demonstrate a more favorable safety profile than Imbruvica (Ibrutinib), with fewer severe side effects. This, according to researchers, makes Brukinsa a potentially safer alternative for patients with CLL, such as those at higher risk for complications from Bruton’s tyrosine kinase (BTK) inhibitors — although, they note that the differences in safety stemmed from variability in baseline clinical characteristics rather than the interventions themselves.
Researchers, who conducted the study between December 2021 and January 2024, published their findings in Hematological Oncology, which drew on data from 200 patients with CLL — half of whom were treated with Imbruvica, and half of whom received the second-generation BTK inhibitor Brukinsa.
“In summary, our study demonstrates that both [Imbruvica] and [Brukinsa] are effective therapies for patients with CLL, with comparable efficacy across various clinical and genetic subgroups,” researchers concluded in the study. “However, [Brukinsa’s] more favorable [side effect] profile, particularly with respect to neutropenia and hematologic toxicities, suggests it may be better suited for patients at higher risk of infections or those requiring long‐term therapy. Conversely, [Imbruvica] may still be the preferred agent in patients with less impaired performance status. These findings highlight the importance of personalized treatment approaches in the management of CLL, taking into account the individual patient's clinical characteristics, comorbidities and risk factors.”
The mean ages of patients in the Imbruvica and Brukinsa arms were 49.65 and 49.16 years, respectively. Researchers reported that the Brukinsa arm had more patients with worse ECOG status (71% versus 57%), but fewer patients treated with Brukinsa experienced severe side effects (4% versus 9%) or serious side effects (8% versus 17%) and only patients in the Imbruvica group experienced neutropenia (3%). The most common serious side effects were sepsis (8% of the Imbruvica group versus 4% of the Brukinsa group) and heart failure (3% versus 1%).
“One of the most striking findings in our study was the absence of neutropenia in the [Brukinsa] group, compared to a 3% occurrence in the [Imbruvica] group. Given that neutropenia is a significant risk factor for infections and poor clinical outcomes, this difference may be clinically meaningful, particularly in older or more frail patients where maintaining neutrophil counts is critical.”
Furthermore, subgroup analysis displayed a higher complication rate with Brukinsa in patients with non-refractory disease (11.4% versus 5.26%), while stage 3 CLL was a protective factor of grade 3 (severe) or higher side effects and serious side effects, and chromosome 17p deletion was found to be the main risk factor for serious side effects.
“It is also worth noting that despite its more favorable toxicity profile, [Brukinsa] was associated with a higher rate of [serious side effects] in patients without refractory CLL, as well as those with elevated beta2‐microglobulin levels and longer disease duration,” researchers wrote. “These findings suggest that while [Brukinsa] may be safer in certain populations, it may carry a higher risk in others, underscoring the importance of individualized treatment decisions based on clinical characteristics and patient comorbidities.”
In the study, Brukinsa was administered orally, 160 milligrams (mg) twice daily, while Imbruvica was administered orally, 420 mg once daily, and treatment was continued until disease progression, unacceptable toxicity or patient withdrawal from the study. Researchers reported that dose reductions and interruptions were allowed.
Dose reductions and treatment discontinuation due to side effects were more common in the Imbruvica group (5% versus 2% and 7% versus 3%) were more common in the Imbruvica group, and there were two side effect-related deaths in the Imbruvica group versus none in the Brukinsa group.
Imbruvica, as defined by the National Cancer Institute, blocks the protein BTK, which may help prevent cancer cells from growing, and may also lower the body’s immune response. Brukinsa, the National Cancer Institute explained, also works by blocking BTK.
“These findings provide valuable insights for clinicians managing patients with CLL, particularly in selecting between [Imbruvica] and [Brukinsa],” researchers wrote. “The slightly improved safety profile of [Brukinsa], particularly with respect to hematologic toxicities and the absence of neutropenia, may make it a preferable option for patients at higher risk of infections or those requiring long-term treatment with minimal interruptions. On the other hand, [Imbruvica] may still be the agent of choice in patients with less impaired performance status, as it was associated with fewer complications in this subgroup.”
Reference:
“Comparative Safety of Ibrutinib Versus Zanubrutinib in Patients With Chronic Lymphocytic Leukemia: A Prospective Cohort Study” by Dr. Fuli Fan, et al., Hematological Oncology.
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