Phase III GLOW study of Imbruvica + Venclexta meets primary endpoint in CLL/SLL.- AbbVie

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. I+V is the first all-oral, once-daily, chemotherapy-free, fixed-duration investigational combination. The PFS benefit with I+V was consistent across pre-specified subgroups, including patients 65 years and older and those with comorbidities (CIRS >6). The median PFS for C+O was 21 months while the median PFS for I+V had not been reached at the time of analysis. The safety profile of I+V was generally consistent with the safety profile of the single agents and tolerability profiles were consistent with CLL treatment in the enrolled patient population. Secondary endpoints included rates of undetectable minimal residual disease (uMRD), complete response rate (CR) and overall response rate (ORR). The rate of uMRD in the bone marrow as assessed by next generation sequencing was significantly higher for patients treated with I+V compared to those treated with C+O (p<0.0001). three months after the completion of treatment umrd was observed in 51.9% and 17.1%, respectively. peripheral blood (pb) umrd persisted 12 months after end of treatment in 49% with i+v and 12% with c+o. the cr rate was also significantly higher with i+v vs. c+o (38.7% vs. 11.4%) (p>< 0.0001). The ORR was not significantly different between I+V and C+O treated groups. Time to subsequent therapy was longer for I+V (HR 0.143, 95% CI 0.05-0.41). Results of the study will be presented at the European Hematology Association (EHA) 2021 Virtual Congress.</0.0001).>