NORTH CHICAGO, Ill., June 12, 2026
AbbVie announced new long-term clinical results from the Phase 3 CLL14 trial at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden, highlighting the durable efficacy and safety of VENCLEXTA®/VENCLYXTO® (venetoclax) in combination with obinutuzumab for previously untreated chronic lymphocytic leukemia (CLL). The final nine-year analysis demonstrated that patients receiving the fixed-duration venetoclax-based regimen experienced prolonged progression-free survival, extended time to next treatment, and sustained clinical benefit years after completing therapy, reinforcing the regimen’s role as a leading frontline option for CLL patients with coexisting medical conditions.
Nine-Year Follow-Up Shows Durable Disease Control
The final analysis of the CLL14 Phase 3 study showed that treatment with venetoclax plus obinutuzumab achieved a median progression-free survival (PFS) of 6.4 years, compared with 3.2 years for patients treated with chlorambucil plus obinutuzumab. After a median follow-up of 9.2 years, the venetoclax-based regimen maintained a statistically significant reduction in the risk of disease progression or death. Importantly, the study reported a median time to next treatment (TTNT) of 7.6 years, meaning many patients remained free from additional CLL therapy for nearly eight years after completing the one-year fixed-duration treatment course. Investigators noted that these findings confirm the long-term durability of venetoclax-based therapy and support the concept that a limited-duration regimen can provide prolonged remission without continuous treatment exposure.
Fixed-Duration Venetoclax Therapy Continues to Redefine CLL Care
The CLL14 trial enrolled 432 previously untreated CLL patients with coexisting medical conditions, including impaired renal function or elevated comorbidity scores. Patients received either venetoclax plus obinutuzumab or chlorambucil plus obinutuzumab, with venetoclax administered for a fixed duration of 12 months. The trial was conducted in collaboration with the German CLL Study Group and was designed to evaluate whether a chemotherapy-free, fixed-duration regimen could improve outcomes in a population often considered less fit for intensive therapy. The nine-year results strengthen the evidence that VENCLEXTA/VENCLYXTO can deliver deep and durable remissions while allowing patients substantial time off treatment. Clinicians emphasized that avoiding indefinite therapy may reduce cumulative toxicity, improve quality of life, and lessen the long-term burden of chronic leukemia management.
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Safety Profile Remains Consistent After Extended Follow-Up
AbbVie reported that the long-term safety profile of the venetoclax combination remained consistent with previous analyses, with no new safety signals emerging during extended follow-up. The most common Grade 3 or higher adverse events included neutropenia, thrombocytopenia, infusion-related reactions, anemia, febrile neutropenia, pneumonia, and leukopenia. Venetoclax, a first-in-class BCL-2 inhibitor, works by restoring the natural process of apoptosis in cancer cells and has become a cornerstone therapy in multiple hematologic malignancies.
The company stated that the new data further support venetoclax-based combinations as an important standard-of-care option in frontline CLL treatment. As one of the most common adult leukemias, CLL remains an area of significant unmet need, with many patients requiring long-term disease management and multiple lines of therapy over the course of their illness. The extended follow-up from CLL14 provides one of the longest datasets available for a fixed-duration targeted therapy regimen in CLL and underscores AbbVie’s continued focus on advancing durable, patient-centered treatment approaches in hematologic oncology.
Source: AbbVie press release
