- All-oral, once-daily, chemotherapy-free, fixed-duration ibrutinib plus venetoclax (I+V) combination met its primary endpoint of progression-free survival (PFS) as assessed by an independent review committee (IRC); I+V reduced the risk of disease progression or death by 78% compared to chlorambucil plus obinutuzumab (C+O)

- 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

- Data will be presented during the late-breaking abstract session at the European Hematology Association (EHA) 2021 Virtual Congress (Abstract #LB1902)

NORTH CHICAGO, Ill., June 12, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data from the Phase 3 GLOW study comparing the efficacy and safety of the combination of IMBRUVICA® (ibrutinib) plus VENCLEXTA®/VENCLYXTO® (venetoclax) (I+V) versus chlorambucil plus obinutuzumab (C+O) for first-line treatment in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had active disease requiring treatment per the International Workshop on CLL (iwCLL) criteria. 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. Results of the study will be presented at the European Hematology Association (EHA) 2021 Virtual Congress (Abstract #LB1902) during late-breaking abstract session on June 12 from 4:00-5:30 p.m. CEST.

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.

"With CLL being one of the most common types of blood cancer, the expansion of research into additional treatment options for patients is an important clinical undertaking," said Arnon Kater, M.D., Ph.D., deputy head of hematology, University of Amsterdam Faculty of Medicine. "The progression-free survival findings of ibrutinib and venetoclax in the GLOW study are promising and show the potential to become an additional treatment option for people living with CLL."

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 (p6 or creatinine clearance