Study Supports Efficacy, Safety of Orelabrutinib in Relapsed/Refractory MCL

Highly selective and irreversible Bruton’s tyrosine kinase inhibitor orelabrutinib was associated with continuous efficacy in a study of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL).

Yuqin Song, MD, of the Peking University Cancer Hospital & Institute in Beijing, presented findings from the open-label, multicenter study at the 62nd American Society of Hematology Annual Meeting & Exposition.

In the study, Dr. Song and colleagues evaluated the objective response rate (ORR), safety, as well as duration of response (DOR), progression-free survival (PFS), and overall survival (OS) in 106 patients with R/R MCL treated with orelabrutinib.

The study featured a median follow-up duration of 15 months. The majority of patients were men (79.2%), and the median age of the population was 62 years. Additionally, approximately 73.6% of patients had stage IV disease.

Up to 87.9% of patients had an ORR, and 93.9% of patients achieved disease control during treatment. While the median DOR was not reached, the 12-month DOR rate was 73.7%.

Additionally, the median PFS and OS was not reached, but the 12-month PFS and OS were 70.8% and 88.7%, respectively. The complete response rate increased to 27.4% compared with results of previous analyses, the investigators said. They added that treatment with orelabrutinib demonstrated efficacy in patients irrespective of age, sex, disease status or stage, and prior therapy. Additionally, orelabrutinib featured an “excellent” safety profile.

Treatment-related adverse events (AEs) reported in this patient population were primarily hematologic in nature and included thrombocytopenia, neutropenia, leukopenia, and hypertension. Thrombocytopenia was the most frequently reported grade 3 or higher AE.

“The improved safety as a result of high target selectivity, and the convenience of daily dosing regimen provides orelabrutinib as preferred therapeutic choice for B-cell malignancy,” the researchers