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ASH 2025 | Long-term efficacy of zanubrutinib in patients with R/R CLL enrolled in the ALPINE trial
Constantine Tam, MBBS (Hons), MD, FRACP, FRCPA, Alfred Hospital and Monash University, Melbourne, Australia, discusses the long-term outcomes of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) receiving zanubrutinib in the Phase III ALPINE study (NCT03734016) and the subsequent long-term extension (NCT04170283). Prof. Tam notes that the long-term follow-up data confirm the durable efficacy and sustained progression-free survival (PFS) benefit of zanubrutinib, including in patients with deletion 17p. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So the ALPINE study is a study that randomized relapsed/refractory patients with CLL to either ibrutinib or zanubrutinib. The study has previously been published. The headline results are that zanubrutinib is superior to ibrutinib in terms of progression-free survival and also had reduced toxicity and in particular a reduced risk of atrial fibrillation.
Now, the ALPINE study has finished, but we wanted to know what the long-term outcome of those patients on zanubrutinib are...
So the ALPINE study is a study that randomized relapsed/refractory patients with CLL to either ibrutinib or zanubrutinib. The study has previously been published. The headline results are that zanubrutinib is superior to ibrutinib in terms of progression-free survival and also had reduced toxicity and in particular a reduced risk of atrial fibrillation.
Now, the ALPINE study has finished, but we wanted to know what the long-term outcome of those patients on zanubrutinib are. So the abstract we’re presenting are those patients who were enrolled in ALPINE, who then rolled over to a long-term extension study receiving zanubrutinib. And this allows us to tell you what the long-term progression-free survival of patients receiving zanubrutinib for relapsed/refractory CLL is.
So we now have up to six years of follow-up in that cohort and we now have a median progression-free survival of five years. So patients who get treated for relapsed/refractory CLL with zanubrutinib have a five-year median remission as confirmed on ALPINE and documented on the long-term extension study.
The other thing is that we looked at the 17p patients. Now the 17p patients are the ones who derive the most benefit from zanubrutinib relative to ibrutinib. And now with extended follow-up, we can see that the median progression-free survival for relapsed/refractory CLL and 17p, so both bad prognostic factors together, is 50 months, so over four years, which is some of the best data that we’ve seen for any drug in the setting of relapsed/refractory CLL.
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