Efficacy and safety of Orelabrutinib-based regimens in diffuse large B-cell lymphoma: a single-center retrospective analysis

Abstract Currently, combining chemotherapy with Bruton tyrosine kinase inhibitors (BTKi) has demonstrated significant effectiveness in treating patients with diffuse large B-cell lymphoma. Orelabrutinib is a second-generation BTK inhibitor, and presently, there have been few reports of Orelabrutinib being used to treat DLBCL. We conducted a retrospective investigation to explore the safety and efficacy of Orelabrutinib in combination with chemotherapy or immunotherapy. The study comprised 19 patients with a median age of 61 years. The overall response rate (ORR) was 89.5% with a complete response (CR) rate of 73.7% and a partial response rate (PR) of 15.8%. The estimated 2-year overall survival (OS) and progression-free survival (PFS) rates were 78.6% (95%CI, 59.8%–100%) and 72.2% (95% CI, 52.4%–99.6%), respectively, with a median follow-up time of 11 months (range 2–24). The most prevalent grade 3 or 4 adverse events (AEs), neutropenia (52.6%), anemia (36.8%), thrombocytopenia (26.3%), febrile neutropenia (26.3%), and lung infection (10.5%), were the most common. Our results reveal that Orelabrutinib is an effective therapy for DLBCL patients. Furthermore, our first investigation of the Orelabrutinib application lays a foundation for larger retrospective studies.