Orelabrutinib in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma patients: Multi-center single-arm, open-label, phase 2 study

In this single-arm phase 2 study of 80 patients with relapsed or refractory CLL/SLL, orelabrutinib, a novel covalent BTK inhibitor, demonstrated an IRC-assessed ORR of 92.5% including in patients with TP53 mutations, del(17p), del(11q), and unmutated IGHV. At a median follow up of 32.3 months, median PFS has not yet been reached. Nearly all patients reported at least one treatment-related adverse event, with the majority (86.8%) of events being grade 2 or lower. Common side effects included hemorrhage (20%), with 2.5% of patients experiencing a major hemorrhage event. There was no atrial fibrillation reported, and grade 3 or greater hypertension was reported in one patient.