Final analysis of the prospective multicenter CLL2-GIVe trial of obinutuzumab (GA101, G), ibrutinib (I), and venetoclax (Ve) in untreated patients with CLL with 17p deletion/TP53 mutation
Presented at the most recent ASH meeting, the final analysis of the open-label multicenter phase 2 CLL2-GIVe trial demonstrated a complete response rate of 58.5% and a partial remission rate of 41.5% for patients with TP53 mutations and/or del17p who received 6 cycles of obinutuzumab, ibrutinib, and venetoclax, with venetoclax and ibrutinib continued for an additional 6 cycles. Individuals who did not demonstrate complete response and undetectable minimal residual disease at Cycles 9 and 12, ibrutinib was continued for 23 additional cycles (13-36). After a median follow-up time of 38 months, the estimated 36-month overall survival is 92.6% and the median overall survival has not been reached. Estimated progression-free survival (PFS) at 36 months is 79.9%.