Excellent CR rates for venetoclax plus pola-R-CHP in BCL2-positive DLBCL

Venetoclax added to polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) was associated with high complete response (CR) rates and encouraging progression-free survival (PFS) in patients with newly diagnosed high-risk BCL2-positive diffuse large B-cell lymphoma (DLBCL).

The phase 1b BO42203 trial (NCT04790903) assessed a treatment regimen of venetoclax plus pola-R-CHP in patients with BCL2-positive DLBCL [1]. The 50 participants were previously untreated and had an IPI score between 2 and 5. Dr Catherine Diefenbach (NYU Langone Health, NY, USA) shared the findings from the final study analysis.

“Although there were no observed dose-limiting toxicities, we maintained the lower-dose venetoclax schedule, which comprised 800 mg venetoclax on days 1 to 5 of a 21-day cycle,” outlined Dr Diefenbach. Almost three-fourths of the participants experienced at least 1 adverse event of grade 3 or higher, and 14% discontinued any of the study drugs. “There were 2 treatment-related deaths, being a case of cardiac arrest related to venetoclax treatment and a case of sepsis linked to the combination of agents,” said Dr Diefenbach. Neutropenia (60.0%), febrile neutropenia (18.0%), and leukopenia (14.0%) were the most common grade 3 or higher events. Sepsis (10.0%) and other grade 3 or higher infections (14.0%) were other frequently reported adverse events.

The overall response rate was 86.0%, and the CR was 82.0%, which was “extremely high for this population,” according to Dr Diefenbach. Furthermore, the 1-year PFS rate was 75.5%, and the 1-year overall survival rate was 91.7%.

“We saw high CR rates in this population of mostly high-risk patients with BCL2-positive DLBCL,” concluded Dr Diefenbach. “And as a final remark, I would like to highlight the duration of response of 13.7 months and CR rate of 100% in the 7 participants with double-hit/triple-hit lymphoma.”

1. Diefenbach CS, et al. Final analysis of the safety and efficacy of venetoclax in combination with Pola-R-CHP for untreated high-risk BCL-2-positive B-cell lymphoma including double/triple hit lymphoma. Abstract 577, 66^th ASH Annual Meeting, 7–10 December 2024, San Diego, CA, USA.

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Posted on 29 January 2025