SEQUOIA Arm D results: Zanubrutinib + venetoclax in patients with TN CLL/SLL

Results from Arm D of the phase III SEQUOIA trial (NCT03336333), evaluating the efficacy and safety of zanubrutinib maintenance after 24 months of zanubrutinib + venetoclax in 114 treatment-naïve patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) with or without del(17p)/TP53 mutation, were published by Shadman et al. in the Journal of Clinical Oncology.

Key data: The median follow-up was 31.2 months. In patients with vs without TP53 mutations, the 24-month progression-free survival (PFS) was 94% vs 89%, the overall response rate (ORR) was 99% vs 96%, and the rate of undetectable measurable residual disease (uMRD) was 59% vs 60%. The most common Grade ≥3 treatment-emergent adverse event (TEAE) was neutropenia (17%).

Key learning: The data show zanubrutinib + venetoclax followed by zanubrutinib monotherapy was effective with a favorable safety profile in patients with CLL/SLL, irrespective of TP53 mutation status.