Final analysis of the CLL2-GIVe trial: Obinutuzumab, ibrutinib, and venetoclax for untreated CLL with del(17p)/TP53mut

Authors present the final analysis of the phase 2 CLL2-GIVe, which examined the use of obinutuzumab, ibrutinib, and venetoclax as frontline therapy for high-risk CLL (del17p/TP53+). The 41 patients received 6 cycles of all 3 agents, up to 12 cycles of venetoclax, and up to 36 cycles of ibrutinib based on response assessment including measurable residual disease (MRD) status. The authors report a complete response rate of 58.5% (95% CI: 42.1-73.7; P < .001) at cycle 15. After a median observation time of 38.4 months off treatment, the 36-month progression-free survival was 79.9%, and the 36-month overall survival rate was 92.6%. The most common adverse events included neutropenia (grade ≥ 3) in 48.8% of patients, and grade > 3 infections in 19.5% of patients. Grade 3 cardiotoxicity in the form of atrial fibrillation and hypertension occurred in 2.4% and 4.9% of patients, respectively. Incidence of all grades of adverse events was highest during induction and decreased over time.