New Reference: Zanubrutinib for Treatment-Naive CLL

Phase 3, randomized, open-label trial (SEQUOIA)

Treatment-naïve CLL/SLL pts without del(17p)

Zanubrutinib 160 mg BID until progression vs. Bendamustine + Rituximab (6 cycles)

PFS: NR vs. 44.1 mos (zanubrutinib vs. BR) (HR: 0.29 [0.21-0.40])

5-yr PFS: 75.8% vs. 40.1%

PFS (IGHV mutated): HR 0.40 [0.23-0.69]

PFS (IGHV unmutated): HR 0.21 [0.14-0.33]

OS: NR in both arms; 5-yr OS: 85.8% vs. 85.0%

Grade ≥3 AEs: Zanubrutinib (67.9%), BR (74.4%)

Atrial fibrillation: 7.1%

Infections: 30.0% vs. 22.5%

Neutropenia: 12.5% vs. 51.1%

Bleeding: 7.5% vs. 1.8%

Shadman M,Munir T,Robak T Zanubrutinib Versus Bendamustine and Rituximab in Patients With Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Median 5-Year Follow-Up of SEQUOIA

Reviewed by Ulas D. Bayraktar, MD on Mar 14, 2025