Sonrotoclax / BGB-11417 + Zanubrutinib

2026-05-29 — BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235) reported long-term and real‑world data for BRUKINSA (zanubrutinib) in chronic lymphocytic leukemia (CLL) at the 2026 ASCO Annual Meeting, and highlighted combination results with BEQALZI (sonrotoclax).

In the Phase 3 SEQUOIA first-line CLL/SLL study (median follow-up 84.01 months), 78‑month progression‑free survival (PFS) was 71.8% (95% CI 65.3–77.3) with BRUKINSA vs 31.0% (24.3–37.9) with bendamustine‑rituximab; COVID‑adjusted PFS was 74.6% vs 31.4%. Time to next treatment favored BRUKINSA (HR 0.24; P<0.0001) with no new safety signals.

Real‑world analyses cited: Medicare cohort (n=10,523) showed lower risk of death/next line/discontinuation vs ibrutinib or acalabrutinib; Komodo claims (n=16,788) showed longer TTNT (HR 0.88; P=0.009) and OS (HR 0.72; P<0.001); atrial fibrillation at 1 year was 11% with BRUKINSA vs 13% acalabrutinib and 16% ibrutinib.

In a Phase 1/1b treatment‑naïve CLL/SLL study (~34 months follow-up), BRUKINSA+sonrotoclax achieved ORR 100% (CR 59.5%) and uMRD4 98.8%, suggesting potential for time‑limited regimens.