Breaking News: Zanubrutinib Shows Impressive Long-Term Results in Treating Relapsed/Refractory CLL/SLL!
For those battling relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), the news is promising. A recent study reveals that zanubrutinib (also known as Brukinsa) continues to demonstrate significant benefits even after 5 years of follow-up. This is a game-changer for patients who have seen their cancer return after initial treatments.
This positive data comes from the BGB-3111-LTE1 study (an extension of the phase 3 ALPINE study), presented at the 2025 ASH Annual Meeting & Exposition. With a median follow-up of 54.2 months, the results are compelling. Patients treated with zanubrutinib experienced a median progression-free survival (PFS) of 52.5 months. That means, on average, patients lived over four years without their disease worsening. When accounting for COVID-19, the median PFS reached 60.3 months!
The 60-month PFS rate was 47.3%, and even better, it was 50.4% when considering deaths related to COVID-19. This suggests that zanubrutinib not only helps control the disease but also offers a sustained benefit over time. Dr. Constantine Tam, a leading hematologist, noted that the drug continues to show durable efficacy, with many patients from the original ALPINE study continuing on zanubrutinib in the long-term extension.
Let's break down the study design:
The ALPINE study was an open-label, randomized trial involving patients with relapsed/refractory CLL/SLL across 113 sites globally. To be eligible, patients needed to meet specific criteria, including being at least 18 years old, having a confirmed CLL diagnosis, and having measurable disease. The LTE1 study included 189 patients, with 176 continuing on zanubrutinib.
Patients received zanubrutinib at 160 mg twice daily. The main goal of the study was to assess safety, but researchers also looked at PFS, duration of response, and overall survival (OS).
Who were the patients?
At the start of the ALPINE study, patients had a median age of 67 years. Most were male (65.1%), White (79.8%), and had a good performance status. The median number of prior treatments was 1, indicating that these patients had already tried other therapies.
Long-Term Safety and Efficacy: What does it mean?
The study also revealed that the complete response (CR) or CR with incomplete bone marrow recovery (CRi) rate increased to 12.8% after extended follow-up. The median PFS for patients with del(17p) was 49.9 months. The 60-month PFS rates overall and following adjustment for COVID-19 were 38.2% and 40.5%, respectively.
The median treatment exposure for patients on zanubrutinib was 52.5 months, and nearly 80% of patients received the drug for at least 24 months. The safety profile of zanubrutinib was consistent with previous findings. The most common adverse effects (AEs) included COVID-19 (42.3%), upper respiratory tract infection (32.7%), hypertension (27.5%), and neutropenia (25.6%).
But here's where it gets controversial...
Serious AEs, treatment-related AEs, and fatal AEs were reported. However, Dr. Tam noted that most of the key AEs either remained stable or decreased over time. The data supports zanubrutinib as an effective treatment for relapsed/refractory CLL, even in patients with the del(17p) mutation.
In Conclusion:
Zanubrutinib continues to show promise in the treatment of relapsed/refractory CLL/SLL, offering sustained PFS and manageable safety. The long-term data provides hope for patients and supports zanubrutinib as a valuable treatment option. What do you think about these results? Do you have any questions or thoughts about the potential impact of zanubrutinib on CLL/SLL treatment? Share your insights in the comments below!
