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Brukinsa had a lower risk of disease progression or death versus Imbruvica, as well as a more favorable safety profile, in R/R CLL and SLL.
Treatment with Brukinsa (zanubrutinib) demonstrated better efficacy compared with Imbruvica (ibrutinib), as well as an improved overall safety and tolerability profile in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
“Given the demonstrated superior efficacy and safety profile of [Brukinsa versus Imbruvica was] longer than [three] years, we felt it was not in the best interest of patients to continue [Imbruvica],” first study author, Dr. Jennifer R. Brown, and co-authors wrote in the study findings which were published in Blood,
Brown is Director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute and a Worthington and Margaret Collette Professor of Medicine in the Field of Hematologic Oncology at Harvard Medical School, both located in Boston, Massachusetts.
After a median follow-up of 42.5 months, Brukinsa demonstrated a 32% reduction in the risk of disease progression or death compared with Imbruvica. Notably, these findinger were even more pronounced in patients with the del(17p)/TP53 mutation, with a 49% risk reduction observed; these findings were consistent across multiple sensitivity analyses.
Progression-free survival: how long patients live without their disease getting worse.
Overall survival: how long patients live after diagnosis.
Partial response: some tumor shrinkage but not complete disappearance.
Complete response: complete disappearance of cancer.
Rate of atrial fibrillation or flutter: how often irregular heartbeats occur.
Overall response rate: the proportion of patients who show any level of tumor shrinkage.
Brukinsa demonstrated a higher overall response rate (ORR) compared with Imbruvica at 85.6% versus 75.4%, respectively. Responses deepened over time with complete response (CR) rates of 11.6% (Brukinsa) and 7.7% (Imbruvica), including CRs with incomplete bone marrow recovery. Additionally, fewer patients treated with Brukinsa died compared with patients treated with Imbruvica, representing a 23% reduction in risk.
In the Brukinsa and Imbruvica treatment groups, respectively, the most common nonhematologic side effects included COVID-19-related infection (46% versus 33.3%), diarrhea (18.8% versus 25.6%), upper respiratory tract infection (29.3% versus 19.8%) and hypertension (27.2% versus 25.3%). Median exposure time was 41.2 and 37.8 months.
“Although higher rates of any-grade COVID-19 were reported in the [Brukinsa group], fewer COVID-19–related deaths and fewer treatment discontinuations because of COVID-19 occurred on the [Brukinsa group] compared with [Imbruvica],” study authors wrote.
In total 43 patients died due to COVID-19, of which, 21 occurred in the Brukinsa group and 22 in the Imbruvica group.
Despite similar rates of hypertension, cardiac side effects were lower with Brukinsa (25.9% versus 35.5%) and incidence of atrial fibrillation or flutter was lower with Brukinsa versus Imbruvica (7.1% versus 17%). No cardiac deaths were reported with Brukinsa, compared with six cardiac deaths reported with Imbruvica treatment.
Fewer patients treated with Brukinsa discontinued treatment due to side effects compared with those treated with Imbruvica. Treatment discontinuation occurred due to side effects in 21.4% and 28.3% in the Brukinsa and Imbruvica group’s, respectively; 18% and 22.5%, respectively, of those discontinuations were due to disease progression. Dose interruptions or reductions due to side effects were reported in 59.3% and 62% of patients treated with Brukinsa versus Imbruvica. Additionally, hospitalizations due to side effects were less frequent among those on the Brukinsa (48.5%) compared with the Imbruvica group (57.1%).
A total of 652 patients were enrolled onto the open-label study, of whom 327 received Brukinsa and 325 received Imbruvica. Participants were randomly allocated (1:1) to receive either Brukinsa at a dose of 160 milligrams twice daily or Imbruvica at a dose of 420 milligrams once daily. Treatment continued until disease progression or the development of intolerable side effects.
The primary end goal of this study included ORR, CR, CR with incomplete bone marrow recovery, nodular partial response and partial response. Key secondary end goals included progression-free survival, the rate of atrial fibrillation or flutter, overall survival and safety parameters.
“Thus, this ad hoc analysis represents the final comparative analysis of the ALPINE study and confirms the improved safety and efficacy of [Brukinsa] compared with [Imbruvica] in patients with [relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma],” study authors concluded.
Reference:
“Sustained benefit of zanubrutinib vs ibrutinib in patients with R/R CLL/SLL: final comparative analysis of ALPINE,” by Dr. Jennifer Brown, et al. Blood.
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