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UPDATED EFFICACY AND SAFETY RESULTS OF ORELABRUTINIB IN THE TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL CELL LEUKEMIA

Background : In clinical trials, treatment of chronic lymphocytic leukaemia (CLL) with venetoclax (Ven) has shown promising efficacy and good tolerability. However, patients treated in clinical trial often represent a selected group not representative for patients treated in daily practice. Prospective real ‐ world data on Ven usage are limited. Aim : We conduct a prospective non ‐ interventional observational study assessing effectiveness, safety, and quality of life in relapsed/ refractory patients (RR) treated with Ven in Austria, Germany, and Switzerland. The population enrolled is representative for remain on therapy. The reported best overall response at 12 months was 67,4% (CR + CRi 32,6%; PR: 34,8%). Conclusion : Under real ‐ world conditions, Ven monotherapy is used in elderly R/R CLL patients. The treatment was well tolerated. Patients presented with high ‐ risk features, e.g. del17p or BCRi pre-treatment; yet, the response rate was high and the proportion of patients with deep response increased over time. Our study confirms findings from Venetoclax Phase ‐ II ‐ studies in R/R CLL patients treated under real ‐ world conditions. The research was funded by: AbbVie sponsored this study and contributed to the design, study conduct, and analysis. AbbVie participated in the interpretation of data, review, and approval of the abstract. No honoraria or payments were made for authorship. All authors had access to all relevant data.