Genetic markers and front line FCR/BR vs. RVe, GVe and GIVe treatment: Outcome results from the CLL13/GAIA trial

The phase 3 GAIA/CLL13 trial examining treatment-naive patients who did not harbor del(17p) or TP53 mutations compared chemoimmunotherapy against three different time-limited venetoclax combinations: venetoclax plus rituximab, plus obinutuzumab, and plus obinutuzumab and ibrutinib. The co-primary endpoints of the study were progression-free survival and minimal residual disease in peripheral blood at 15 months post-treatment. Both unmutated IGHV and presence of a NOTCH1 mutation were associated with shorter PFS in all arms. Importantly, patients who received venetoclax-based regimens that included obinutuzumab demonstrated improved PFS compared to both the venetoclax plus rituximab and CIT arms.