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Leo I. Gordon, MD, FACP


Novel BTK Inhibitor Under Study in Non–Germinal Center B-Cell–Like DLBCL

By: Gavin Calabretta, BS
Posted: Wednesday, October 5, 2022

The prognosis for patients with non–germinal center B-cell–like (GCB) diffuse large B-cell lymphoma (DLBCL) is generally poor, and this is especially true for those with extranodal invasion. Following previous studies that demonstrated the activity of Bruton’s tyrosine kinase (BTK) inhibitors in relapsed or refractory DLBCL, Mingyue Wang, MD, of Guangxi Medical University Cancer Hospital, Nanning, China, and colleagues analyzed the efficacy and safety of orelabrutinib, a new oral covalent BTK inhibitor, in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in previously untreated patients with non-GCB DLBCL who also had extranodal disease. The results of the study, which were presented at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 627MO), demonstrated activity and an acceptable toxicity profile for the combination treatment.

The study enrolled 22 patients with a median age of 52 years, 10 of whom were male. All patients had immunohistochemistry-confirmed non-GCB DLBCL and extranodal invasion, which was separately confirmed by PET and CT scans. Treatment consisted of six cycles of a 21-day regimen of standard R-CHOP with orelabrutinib. Moreover, of the 22 cases, there were 11 with an International Prognostic Index score of 3 or higher, 12 with double-expressor DLBCL, and 19 with stage IV disease.

The investigators reported that 20 patients responded to treatment, and 17 achieved a complete response, yielding respective overall and complete response rates of 90.9% and 77.3%. The complete response rate was slightly worse in those with double-expressor DLBCL (75%) than in those with non–double-expressor DLBCL (80%). Additionally, although three patients with double-expressor DLBCL had progressive disease after the median follow-up of 11 months, they all survived.

The combination therapy was generally well tolerated over the course of the study, the investigators observed. However, four patients experienced serious adverse events. Three of these individuals developed febrile neutropenia, and another patient developed atrial flutter.

Disclosure: The study authors reported no conflicts of interest.

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