627MO - Orelabrutinib plus RCHOP for previously untreated non-germinal center b cell-like (GCB) diffuse large b cell lymphoma (DLBCL) patients with extranodal disease

Background

The prognosis of patients with non-GCB DLBCL is poor, especially in those with extranodal invasion which has strong invasiveness and rapid clinical progress. How to improve the prognosis of these patients is the main challenge of DLBCL therapy. Bruton tyrosine kinase (BTK) is a member of the non-receptor tyrosine kinase Tec family; it is involved in the proliferation, adhesion and metastasis of B cells. BTK inhibitor showed activity in relapsed/refractory non-GCB DLBCL. Orelabrutinib is a new oral covalent BTK inhibitor; this study aimed to analyze the efficacy and safety of orelabrutinib plus RCHOP for previously untreated non-GCB DLBCL patients with extranodal disease.

Methods

Patients with IHC-confirmed non-GCB DLBCL and PET-CT confirmed extranodal invasion were enrolled in this study. Patients received standard RCHOP with orelabrutinib(150 mg/d, po) on a 21-day cycle for 6 cycles.Primary end point was response rate, secondary end points included progression-free survival (PFS), overall survival (OS), and safety.

Results

22 patients were enrolled, with a median age of 52 years (21-72), including 10 males,11 cases with IPI equal to or greater than 3 points,12 cases with double expressor (DE) DLBCL, and 19 cases with stage IV disease. The overall response rate was 90.9%( 20/22), complete response (CR) rate was 77.3% (17/22). The CR rate was 75% (9/12) in patients with DE DLBCL and 80% (8/10) in those with non-DE DLBCL.The median follow up was 11 months,3 patients with DE DLBCL had progressive disease, all patients survived. Serious AEs included febrile neutropenia (3 cases) and atrial flutter (1 case).

Conclusions

The efficacy of orelabrutinib plus RCHOP for non-GCB DLBCL with extranodal disease is impressive in this single center clinical practice and the toxicity is acceptable.

Clinical trial identification

Legal entity responsible for the study

The authors.

Funding

Natural Science Foundation of Guangxi Province, Grant/Award Number: 2018GXNSFBA281026.

Disclosure

All authors have declared no conflicts of interest.