A Multicenter Real-World Study of Outcomes in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with a Polatuzumab Vedotin-Based Regimen in a Compassionate Use Program in Malaysia.

Abstract

Background: Polatuzumab vedotin + bendamustine + rituximab (Pola-BR) was recently approved in Malaysia for treating relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). A multicenter retrospective study was conducted to assess the effectiveness of this regimen among patients in a compassionate use program.

Objective: To determine treatment response and survival rates for R/R DLBCL patients treated with Pola-BR in Malaysia.

Methodology: Safety and efficacy data of 23 adults with R/R DLBCL treated with Pola-BR at nine centers in Malaysia (September 2019-February 2021) were used. Of the 23 patients, 13 received six cycles of Pola-BR. The median follow-up was 10 months (1-37 months). The primary endpoint was complete response (CR) rate; secondary endpoints were overall survival (OS), progression-free survival (PFS), and adverse events (AEs).

Results: The overall response rate was 56.5%, with 34.8% achieving CR. The 1-, 2-, and 3-year OS rates were 51.6%, 51.6%, and 44.2%, respectively, with a median OS of 27 months. The 1- and 2-year PFS rates were 48.2% and 41.3%, respectively, with a median PFS of 10 months; 60% of the nonresponders had progressive disease. Cox proportional hazard regression analysis showed that bulky disease was a significant hazard for disease progression. A total of 42 AEs were recorded, of which 66.7% were grade ≥ 3 AEs; 90.5% of the AEs were hematological and resolved with treatment; only one patient succumbed to neutropenic sepsis.

Conclusions: Pola-BR has a favorable safety profile for R/R DLBCL treatment in Malaysia, although larger sample sizes and longer follow-ups are needed to confirm these results.