BeiGene(BGNE) Businesswire·2024-02-29 15:00Core Insights - BeiGene announced a new matching adjusted indirect comparison (MAIC) showing BRUKINSA (zanubrutinib) has advantages in progression-free survival and complete response over acalabrutinib in relapsed or refractory chronic lymphocytic leukemia (CLL) [1][2] - The analysis will be presented at the 28th Annual International Congress on Hematologic Malignancies in Miami from February 29 to March 3 [1] Efficacy Comparison - The MAIC indicates that BRUKINSA shows improved investigator-assessed progression-free survival with a hazard ratio (HR) of 0.77 (95% CI: 0.55-1.07) in the unadjusted population and HR of 0.68 (95% CI: 0.46-0.99) in the adjusted population [3] - The odds ratio (OR) for complete response favored BRUKINSA with OR of 2.88 (95% CI: 1.18-7.02) in the unadjusted population and OR of 2.90 (95% CI: 1.13-7.43) in the adjusted population [3] Study Methodology - The MAIC matched individual patient-level data from the ALPINE trial against aggregate data from the ASCEND trial, using an unanchored MAIC due to the absence of a common comparator arm [2] - Adjustments were made for key patient characteristics and the impact of COVID-19 on study outcomes [2] Previous Limitations Addressed - The new MAIC addresses significant limitations found in a previously published MAIC, including the exclusion of final analysis data from ALPINE and lack of adjustment for COVID-19 impacts [3] BRUKINSA's Market Position - BRUKINSA is the only BTK inhibitor demonstrating progression-free survival superiority compared to ibrutinib in R/R CLL, as shown in the ALPINE trial [3] - The drug is approved in 70 markets globally, including the U.S., China, and EU, and is under development for additional indications [4] Development Program - The global development program for BRUKINSA includes over 5,000 subjects enrolled across 29 countries and regions [5]