Zanubrutinib: 5-Year CLL/SLL Survival Data
- New data suggests that zanubrutinib is an effective treatment for treatment-naive, high-risk patients battling chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) with deletion of the short arm of chromosome...
- Zanubrutinib,a Bruton kinase (BTK) inhibitor,gained FDA approval in 2019 for CLL/SLL.
- The SEQUOIA trial, a global, open-label, randomized phase 3 study, compared zanubrutinib to bendamustine plus rituximab in previously untreated CLL/SLL patients, with or without del(17p).
Zanubrutinib demonstrates meaningful promise as a frontline treatment for high-risk CLL/SLL patients, specifically those with del(17p), according to five-year data from the SEQUOIA study. This research highlights the long-term efficacy of this Bruton kinase (BTK) inhibitor. The findings, soon to be presented at ASCO 2025, reveal impressive progression-free survival rates and robust overall response rates, solidifying zanubrutinib’s position as a valuable treatment option. News Directory 3 keeps you informed on these vital updates. Discover what’s next for patients battling this challenging disease.
Zanubrutinib Shows Promise in treating High-Risk CLL/SLL
Updated may 28, 2025
New data suggests that zanubrutinib is an effective treatment for treatment-naive, high-risk patients battling chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) with deletion of the short arm of chromosome 17 (del[17p]). The findings, stemming from a five-year follow-up of the SEQUOIA study, are slated for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual meeting.
Zanubrutinib,a Bruton kinase (BTK) inhibitor,gained FDA approval in 2019 for CLL/SLL. The initial SEQUOIA trial data demonstrated superior progression-free survival (PFS) and high overall response rates (ORR) in patients, regardless of del(17p) status.
The SEQUOIA trial, a global, open-label, randomized phase 3 study, compared zanubrutinib to bendamustine plus rituximab in previously untreated CLL/SLL patients, with or without del(17p). One arm of the trial featured 111 patients with del(17p) who received zanubrutinib monotherapy. The median age of this group was 71, with ages ranging from 42 to 87. A significant portion of these patients also presented with a TP53 mutation (42%), were male (71%), and had unmutated IGHV (60%).
While the median PFS wasn’t reached during the 65.8-month follow-up, the estimated 60-month PFS was 72.2%, increasing to 73.0% when adjusted for COVID-19. Similarly, the median overall survival (OS) wasn’t met, but the 60-month estimate stood at 85.1%, or 87% with COVID-19 adjustment.The overall response rate was a clinically meaningful 97.3%,with a complete response rate of 18.2%.
More than 62% of patients continued zanubrutinib treatment. Discontinuation primarily resulted from adverse events (17.1%) and progressive disease (15.3%). Noted adverse events included any-grade infection (82%), bleeding (60%), and neutropenia (19%).
“Additionally, with longer-term follow-up, no new safety signals were identified,” the authors wrote. “This update, in the largest cohort of uniformly treated patients with del(17p), suggests that zanubrutinib remains a valuable frontline treatment option for patients with or without del(17p) CLL/SLL.”
What’s next
The detailed findings from the SEQUOIA study will be presented at the upcoming ASCO Annual Meeting,offering further insights into the long-term efficacy and safety of zanubrutinib in treating high-risk CLL/SLL patients.