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Annual International Congress on Hematologic Malignancies | 2024

BeiGene presented superiority data of Brukinsa versus Calquence in indirect comparison

BeiGene has unveiled a new analysis comparing the efficacy of Brukinsa® (zanubrutinib) to acalabrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL), utilizing a matching adjusted indirect comparison (MAIC) based on data from the Phase 3 ALPINE and Phase 3 ASCEND trials. This analysis suggests that Brukinsa may offer advantages in terms of progression-free survival, complete response rates, and potentially overall survival compared to acalabrutinib.

In this MAIC, individual patient-level data from the ALPINE trial were matched against aggregate data from the ASCEND trial. An unanchored MAIC approach was employed due to the absence of a common comparator arm between the two trials. Considering the differing study timelines relative to the onset of the COVID-19 pandemic, adjustments were made in the analysis to account for the impact of COVID-19 on outcomes in the ALPINE study.

A previously published MAIC comparing Brukinsa to acalabrutinib had notable limitations, including the exclusion of data from the final analysis of ALPINE, lack of adjustment for COVID-19 impact, and key differences in patient characteristics and sample size. Moreover, complete response rates and overall survival were not factored into the analysis.

While MAIC analyses serve as hypotheses-generating exercises in the absence of head-to-head trial data, evaluating a drug's safety profile may require a comprehensive review of all available evidence across indications. An independent meta-analysis conducted by the Mayo Clinic, encompassing 61 trials involving 6,959 patients treated with ibrutinib plus an anti-CD20 antibody, acalabrutinib, and Brukinsa, extensively examined the adverse event profiles of these therapies across various indications, revealing noteworthy differences in safety profiles.

Brukinsa has received approvals in 70 markets, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea, and Switzerland for selected indications. It remains under development for additional indications globally, with the global Brukinsa development program enrolling over 5,000 subjects across 29 countries and regions to date.


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