EHA 2023 | Updated long-term follow-up of SEQUOIA: zanubrutinib vs bendamustine-rituximab in untreated CLL/SLL

The SEQUOIA study is a randomized trial in patients with CLL or SLL who are previously untreated. And the study was a randomized study comparing zanubrutinib as the investigational arm at the time, and bendamustine and rituximab combination as the control arm. And the study has already been, the initial reports of this study have been presented and published and we knew that zanubrutinib is associated with an improved progression-free survival compared to a bendamustine-rituximab. So, what we’re showing in this updated long-term follow-up, with 44+ months of follow-up, you’re seeing first of all, that difference in progression-free survival is maintained and zanubrutinib is continuing to have a better efficacy from the PFS standpoint.

One of the new findings of this study is that, in the prior report, we did report that patients with an  unmutated IGHV had an improved PFS if they took zanubrutinib compared to bendamustine-rituximab. But in the initial report there was no difference in patients with the mutated IGHV, and these are patients who do well with chemotherapy. However, with the current updated report, we are seeing that, even in patients with the mutated IGHV, we are seeing that zanubrutinib is now statistically significantly better from the PFS standpoint.

So also, the SEQUOIA study included a cohort of patients with deletion in the 17p area and, as we know this is an unmet need, an important group of patients that we’re focused on, so we are providing a long-term follow-up on these patients and their progression-free survival remains to be very favorable in patients who received zanubrutinib monotherapy with basically four-year PFS of 79%. I should mention that zanubrutinib-treated patients without 17p had a 89% PFS at four years. So, these are important numbers to remember when we discuss efficacy of these agents with our patients in clinic.