ALPINE Trial Shows Zanubrutinib Outperforms Ibrutinib in CLL/SLL

Habte Yimer, MD, hematologist/oncologist with Texas Oncology, provides an overview of the ALPINE trial (NCT03734016) and discusses the significance of the sustained progression-free survival (PFS) benefit observed with zanubrutinib (Brukinsa) vs ibrutinib (Imbruvica) among patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The trial aims to determine the efficacy of zanubrutinib, a newer Bruton's tyrosine kinase (BTK) inhibitor, compared with the established one, ibrutinib. Data from the phase 3 trial were presented at the 2023 American Society for Hematology Annual Meeting. According to follow-up data from the phase 3 ALPINE trial, zanubrutinib demonstrated superior PFS and safety signals compared with ibrutinib (Imbruvica) in this patient population.

After a median follow-up of 39.0 months, there was a sustained PFS benefit with zanubrutinib over ibrutinib, reducing the risk for disease progression by 32% (HR, 0.68; 95% CI, 0.53-0.86; P = .0011). This benefit was seen across all subgroups, including age, sex, prior lines of therapy, baseline 17p deletion and/or TP53 mutation status, bulky disease, baseline IGHV mutation status, disease stage, and complex karyotype.

Yimer emphasizes the significance of sustained PFS benefits with zanubrutinib observed up to the 3-year mark, indicating its continued superiority over ibrutinib.

Transcription:

0:09 | ALPINE is a trial that was designed to answer a very important question to see which BTK inhibitors in the market, we have 3 now, which one is better? It was designed to see if the latest generation BTK inhibitor, zanubrutinib, is better than the first generation BTK inhibitor Ibrutinib.

0:34 | I think it is very significant. They show early benefits, which might not carry over into the 3-year or 5-year mark. What we have shown is that the actual progression-free survival benefits that were seen at the 2-year mark actually persisted at the 3-year mark, showing that zanubrutinib still a better progression-free survival than ibrutinib.