On April 28, 2021, it was announced that zanubrutinib has met its primary endpoint of non-inferior objective response rate (ORR), and has demonstrated superior ORR compared with ibrutinib, in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1
In an interim analysis of the phase III ALPINE trial, non-inferior ORR was demonstrated by both investigator and independent review committee (IRC) assessments (p < 0.0001). ORR was significantly improved vs ibrutinib by investigator assessment (p = 0.0006) and numerically higher by IRC assessment, although statistical significance was not reached (p = 0.0121). The trial has also met a pre-specified secondary endpoint for safety, with zanubrutinib showing a significantly lower risk of atrial fibrillation or flutter compared with ibrutinib.1
ALPINE (NCT03734016) is a global, phase III, randomized study of zanubrutinib vs ibrutinib in patients with previously treated CLL or SLL. The primary endpoint is ORR. Secondary endpoints include progression-free survival, overall survival, duration of response, time to treatment failure, patient reported outcomes, and incidence of adverse events.
Zanubrutinib is currently approved in the United States for the treatment of adult patients with mantle cell lymphoma who have received ≥1 prior therapy. These data for patients with CLL/SLL will be presented at an upcoming congress, and ORR by IRC will be further assessed at the final analysis alongside additional secondary endpoints.