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ICML 2025

SEQUOIA 5-year follow-up in Arm C

July 2, 2025

Presented by Dr Mazyar Shadman (Fred Hutchinson Cancer Center, Seattle, USA)

SEQUOIA is a phase III, randomised, open-label trial that compared the oral BTK inhibitor zanubrutinib to bendamustine plus rituximab (BR) in treatment-naïve patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).

At ICML Lugano, Prof Dr Shadman from the Fred Hutchinson Cancer Center in Seattle presented updated results from SEQUOIA ARM C cohort, in patients with del(17p) after approximately 5 years of follow-up.

The cohort consisted of 111 patients who received zanubrutinib as monotherapy. The five-year follow-up data showed high efficacy with continued improvement in responses over time. Specifically, the CR and CR with incomplete response (CRI) rates were approximately 18%. The PFS at five years was reported to be 72%, which is comparable to the PFS observed in patients who received zanubrutinib in the broader arm A of the study in patients without DEL-17P. The data also underscore zanubrutinib’s superiority over ibrutinib in the relapse setting, as shown by the ALPINE study, which included a planned subgroup analysis of DEL-17P patients. No new safety signals were observed, and the treatment was well tolerated, with patients continuing to benefit clinically from the therapy. This reinforces zanubrutinib as a preferred treatment option for DEL-17P patients in both first-line and relapse settings, given its efficacy and safety profile.

References:

  1. Shadman M, et al. ICML 2025; Abstract 072 
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