Can ibrutinib ameliorate outcomes in R/R ABC-DLBCL undergoing autoSCT?

Ibrutinib could safely be added to standard conditioning and consolidation therapy in participants with relapsed or refractory (R/R) activated B-cell diffuse large B-cell lymphoma (ABC-DLBCL) who underwent autologous haematopoietic stem cell transplantation (autoSCT).

In the double-blind, randomised, phase 3 study Alliance A051301/BMT-CTN 1201 (NCT02443077), participants with R/R ABC-DLBCL undergoing autoSCT (n=88) were randomised 1:1 to a conditioning regimen of CBV or BEAM chemotherapy plus ibrutinib, or chemotherapy plus placebo [1]. Participants in the experimental arm received ibrutinib consolidation therapy for 12 cycles, and the control arm received placebo. “The study was closed early due to declining accrual,” said Dr Charalambos Andreadis (University of California San Francisco, CA, USA), who presented the results. “The standard of care for many participants had changed to CAR T-cell therapy during the study.”

“Although somewhat higher rates of cytopenia and infectious complications were observed for participants receiving ibrutinib, this agent can safely be added to conditioning and consolidation treatments in this participant population,” said Dr Andreadis. The estimated 24-month progression-free survival rates suggested that ibrutinib may offer an efficacy benefit (57.6% vs 40.8%; log-rank P=0.087). Overall survival rates were comparable for the 2 study arms (P=0.75).

Overall, ibrutinib appeared to be a safe addition to autoSCT conditioning and consolidation therapy in participants with R/R ABC-DLBCL. Although the efficacy rates hint at an improved progression-free survial with ibrutinib as compared with placebo, the limited sample size of the study decreased the power of the efficacy analysis.

1. Andreadis C, et al. Ibrutinib added to standard conditioning and as consolidation therapy following autologous hematopoietic stem cell transplantation for relapsed/refractory activated-B-cell subtype diffuse large B-cell lymphoma: primary analysis of the US intergroup double-blind randomized phase III study alliance A051301/BMT-CTN 1201. Abstract 437, 65^th ASH Annual Meeting, 9–12 December 2023, San Diego, CA, USA.

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Posted on 7 February, 202415 February, 2024