Transition Into Clinical Routine and Survival Outcomes of BCL2- and BTK Inhibitors: An Analysis of Patient Data From the GCLLSG Registry.

Within a dataset of the German CLL Study Group (GCLLSG) registry, 274 patients were allocated to a cohort with venetoclax and 888 to a cohort with BTKi (79 acalabrutinib, 809 ibrutinib), each as first administered targeted substance class within the documented treatment sequence. Venetoclax was administered as first-line treatment in 152 of 274 patients (55.5%). After a median observation time of 14 months from the start of the first documented venetoclax treatment, the 1-year event-free survival (EFS) was 82.1% and the 1-year overall survival (OS) was 94.2%. The 1-year OS was 96.3% when venetoclax was given as first-line treatment versus 92.1% when given for the first time in a later therapy line (HR 0.38, 95% CI 0.14-1.05). In the BTKi cohort, 351 of 888 patients (39.5%) received a BTKi as first-line treatment. The median observation time was 34 months from the start of the first documented BTKi treatment, with a 3-year EFS of 32.4% and a 3-year OS of 78.5%. The 3-year OS for a BTKi in first-line was 87.9% compared to 73.8% in a later therapy line (HR 0.43, 95% CI 0.30-0.61). Our analysis suggests better survival outcomes when these agents are used as first-line therapy with the caveat that patients treated in later therapy lines typically exhibit more advanced disease and a poorer general condition.