AbbVie presented final Phase 3 CLL14 results for a fixed-duration venetoclax plus obinutuzumab regimen at the EHA 2026 Congress in Stockholm on 11-14 June.
The randomized, open-label trial enrolled 432 previously untreated patients with coexisting conditions (n=216 per arm) and compared venetoclax plus obinutuzumab to obinutuzumab plus chlorambucil. After a median follow-up of 9.2 years, venetoclax plus obinutuzumab produced superior progression-free survival with a median PFS of 6.4 years versus 3.2 years for the chlorambucil arm (hazard ratio 0.50; 95% CI 0.39-0.63; p<0.001).
The nine-year analysis demonstrated a median time to next treatment of 7.6 years. Key secondary endpoints included rates of measurable residual disease in blood and bone marrow and overall and complete response rates.
The most frequently occurring Grade 3 or higher adverse events with the venetoclax combination were neutropenia, thrombocytopenia, infusion-related reaction, anemia, febrile neutropenia, pneumonia and leukopenia.
According to the company, these data support long-term off-treatment efficacy and safety and durable benefit in first-line CLL.
