Abstract We explored the efficacy of the combined ibrutinib + venetoclax in patients with R/R CLL. This phase 2 study enrolled 80 patients between July 2016 and September 2018. Patients received ibrutinib for the first 3 cycles, followed by ibrutinib + venetoclax for 24 cycles. Of 79 treated patients, the median age was 61 years (IQR, 56-69); 65 (65/76, 86%) had unmutated IGHV, and 29 (37%) had either del(17p) or TP53 mutation. The median prior treatments were 1 (range, 1-3). The primary endpoint, best CR/CRi was 67%, with a bone marrow undetectable measurable residual disease (10-4 sensitivity, U-MRD4) rate of 61%. At 95.5 months median follow-up, the estimated 7-year PFS rate was 63.3%. Grade ≥3 neutropenia and thrombocytopenia occurred in 38% and 13% of patients, respectively. The 24-cycle ibrutinib + venetoclax combination led to high rates of CR/CRi and bone marrow U-MRD4 in patients with R/R CLL.
Swaminathan et al. (Thu,) studied this question.