BeiGene's final response assessment for zanubrutinib achieves primary endpoint superiority over ibrutinib

On April 11, BeiGene announced the final response assessment results of the ALPINE study of the global Phase 3 clinical trial of zanubrutinib (Baiyueze®): the independent review committee (IRC) confirmed that in patients with relapsed or refractory (R /R) In adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the BTK inhibitor Baiyueze® (zanubrutinib) demonstrated superior overall response rate (ORR) to ibrutinib )

ALPINE is a randomized, global Phase 3 clinical trial (NCT03734016) evaluating Baiyueze® versus ibrutinib in previously treated relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia Outcomes in patients with cellular lymphoma (SLL)

In this trial, 652 patients were randomized into two groups, one to receive Baiyueze® (160 mg orally twice daily) and the other to receive ibrutinib (420 mg orally twice daily) once) until the patient experiences disease progression or unacceptable toxicity

Early in the trial's interim analysis, Baiyueze® had demonstrated superiority on the trial's primary endpoint, the overall response rate as assessed by the investigator

The ALPINE trial enrolled 652 patients globally, covering Europe (60%), the United States (17%), China (14%), New Zealand and Australia (9%) and other countries and regions

The trial data showed that Baiyueze® was generally well tolerated, and the safety results were consistent with those observed in previous studies

The most frequently reported grade 3 or higher adverse events in the Baiyueze® and ibrutinib groups were neutropenia (14.