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.