Résumé
Developing new therapeutic regimens for relapsed/refractory (R/R) B non-Hodgkin lymphoma (NHL) patients remains a significant unmet clinical need. Our objective was to evaluate atezolizumab (ATE), obinutuzumab (OBI) and venetoclax (VEN) combination in patients with R/R NHL who had received at least one prior anti-CD20-containing immunochemotherapy regimen. We report here the final analysis of the phase II LYSA-promoted multicentre trial (NCT03276468) of this combination in follicular lymphoma (FL, n = 58), diffuse large B-cell lymphoma (DLBCL, n = 58) and marginal zone lymphoma (MZL, n = 20). The primary end-point for FL and DLBCL was not met: ATE, OBI, and VEN resulted in an overall response rate (ORR) at the end of induction (EOI) of 53.6% for FL (cohort 1) and 23.6% for DLBCL (cohort 2) when a minimum of 70% and 48% was expected respectively. The median progression-free survival was 11.0 and 2.7 months in cohorts 1 and 2 respectively. In cohort 3 (MZL), the ORR at the EOI was evaluated at 66.7%. The most frequent adverse events (AEs) were cytopenias. We also observed 7.4% of autoimmune AE imputable to the combination. In this phase II study, ATE, OBI and VEN demonstrated moderate efficacy and a manageable toxicity profile when used as induction and maintenance therapy.