Zanubrutinib Shows Superior Progression-Free Survival for Adult Patients with Chronic Lymphocytic Leukemia in Data To Be Presented at ASH 2022


Zanubrutinib expressed better cardiac safety measures, higher progression-free survival, and lower discontinuation rates in the ALPINE trial compared with compared ibrutinib.

Results from the ALPINE trial show zanubrutinib (Brukinsa; BeiGene) produced superior progression-free survival (PFS) compared ibrutinib (Imbruvica; BeiGene) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). The news will be shared at a late-breaking oral session at the Annual Meeting of the American Society of Hematology (ASH) on December 13, 2022.

Additionally, zanubrutinib performed better across major pre-defined subgroups, including immunoglobulin heavy-chain variable region gene status.

“[Zanubrutinib] is the only (Bruton’s tyrosine kinase [BTK]) inhibitor to demonstrate superior efficacy over ibrutinib in any treatment setting,” said Mehrdad Mobasher, MD, MPH, chief medical officer, Hematology at BeiGene, in a press release. “The ALPINE trial results demonstrate superiority for both PFS and overall response rate (ORR) versus ibrutinib in relapsed or refractory CLL/SLL.”

At the follow up (average 29.6 months), the pre-defined response analysis showed that discontinuation rates were nearly 36% lower for zanubrutinib compared to ibrutinib at 26.3% and 41.2%, respectively. Nearly 25% of new leukemia cases are considered CLL. Although survival is based on successful response to therapy, patients with CLL are known to face consecutive relapses, which could make it harder to find a durable treatment option.

Although zanubrutinib demonstrated a higher PFS than ibrutinib, there were also less zanubrutinib discontinuations from adverse events compared to the other treatment. Among participants, 16.2% on zanubrutinib left the trial compared to 22.8% of patients on ibrutinib. Further, 5% more patients on ibrutinib experienced disease progression.

The most common adverse events (AEs) to zanubrutinib include decreased neutrophil count, which affected 54% of patients, upper respiratory tract infection (47%), decreased platelet count (41%) and hemorrhage (35%). Patients were also affected by decreased lymphocyte count, rash, and musculoskeletal pain.

Further, zanubrutinib exhibited lower rates of atrial fibrillation/flutter than ibrutinib (5.2% and 13.3%), with no grade 5 AEs from cardiac disorders.

Zanubrutinib is a small molecule that inhibits the BTK protein and other malignant B cells. It was designed to continuously inhibit BTK and treat B-cell malignancies by optimizing bioavailability and selectivity. Zanubrutinib is currently being evaluated as a monotherapy and combination therapy in more than 35 trials worldwide.

Zanubrutinib was previously granted accelerated approval for the treatment of adult patients with mantle cell lymphoma (MCL) who have already had 1 prior therapy. It is further indicated to treat Waldenström’s macroglobulinemia (WM) in adult patients, as well as relapsed or refractory marginal zone lymphoma (MZL) in patients who have had 1 anti-CD20-based regimen.

“With nearly 30 months of follow up in this trial, we have seen a very consistent safety and tolerability profile for Brukinsa and look forward to sharing detailed results from this analysis at ASH,” Mobasher said in the release.


BeiGene. BeiGene to Present Final PFS Results from ALPINE Trial Demonstrating Superior PFS for BRUKINSA® Versus IMBRUVICA® in Late-Breaking Oral Session at ASH 2022. News Release. Business Wire. November 22, 2022.

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