BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the results of a matching-adjusted indirect comparison (MAIC) between its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), and acalabrutinib in terms of efficacy. The comparison is based on data from the Phase III ALPINE and Phase III ASCEND studies, which focused on patients with recurrent or refractory chronic lymphocytic leukemia (CLL).
The MAIC matched individual patient-level data from the ALPINE study against aggregate data from the ASCEND study. An unanchored MAIC approach was utilized due to the absence of a common comparator arm in both trials. The analysis accounted for the impact of COVID-19, considering the differing study timelines. The MAIC indicated that investigator-assessed progression-free survival was improved for Brukinsa compared to acalabrutinib in both the unadjusted population (HR=0.77 [95%CI: 0.55-1.07]) and the adjusted population (HR=0.68 [95%CI: 0.46-0.99]). Moreover, the odds ratio (OR) for complete response favored Brukinsa over acalabrutinib in both the unadjusted (OR=2.88 [95%CI: 1.18-7.02]) and adjusted populations (OR=2.90 [95%CI: 1.13-7.43]). Sensitivity analyses were consistent with the base case, and the overall survival trend consistently favored Brukinsa.
Brukinsa has received approval in 70 markets, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea, and Switzerland for selected indications, with ongoing global development for additional indications. The global Brukinsa development program has enrolled more than 5,000 subjects across 29 countries and regions to date.- Flcube.com
