Rocbrutinib, a Highly Selective Fourth-Generation Covalent and Noncovalent BTK Inhibitor, in R/R Non-GCB DLBCL: Efficacy and Safety from a Phase I Study.
Adv TherJul 24, 2026 (epub)
Ningjing Lin, Qingqing Cai, Keshu Zhou et al.
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In 30 seconds
This phase I multicenter study evaluated the efficacy and safety of rocbrutinib, a fourth-generation BTK inhibitor, in 45 Chinese patients with relapsed or refractory non-GCB DLBCL. The overall response rate was 57.8%, with a complete response rate of 33.3%. The study supports further investigation of rocbrutinib in this population.
Key findings
- The overall response rate (ORR) was 57.8% (95% CI: 42.2, 72.3).
- The complete response (CR) rate was 33.3% (95% CI: 20.0, 49.0).
- In the ≥ 200 mg QD cohort, the ORR was 72.2% (95% CI: 46.5, 90.3).
- Treatment-emergent adverse events (TEAEs) were reported in 97.8% of patients.
Why it matters
The findings indicate that rocbrutinib may offer a new treatment option for patients with relapsed or refractory non-GCB DLBCL, a population with limited therapeutic options. Understanding its efficacy and safety profile is crucial for clinicians managing these patients.