AbbVie has presented new long-term Phase 3 data at the EHA 2026 Congress in Stockholm, revealing sustained, nearly decade-long outcomes for patients with previously untreated chronic lymphocytic leukemia.

 

The headline results come from the final analysis of the Phase 3 CLL14 trial, conducted in collaboration with the German CLL Study Group, evaluating a fixed-duration regimen of VENCLYXTO (venetoclax) plus obinutuzumab versus chlorambucil plus obinutuzumab in patients with Chronic Lymphocytic Leukemia and coexisting conditions.

 

After a median follow-up of 9.2 years, the venetoclax-based combination continued to show a clear and durable advantage.

 

“The nine-year results from the landmark Phase 3 CLL14 trial affirm venetoclax's enduring safety and efficacy,” said Daejin Abidoye, vice president and oncology therapeutic area head at AbbVie. 

 

“These data continue to add to the impressive body of evidence supporting the first-line use of venetoclax-based combination regimens in broader CLL patient populations, offering patients unprecedented time to next treatment — and therefore time off treatment — after one year of fixed-duration therapy. This research advances our mission to transform care and deliver better outcomes for patients living with difficult-to-cure blood cancers.”

 

The clinical impact was equally striking in investigator commentary.

 

“Venetoclax in combination with obinutuzumab has shown positive responses across several key measures compared to obinutuzumab plus chlorambucil, including an extended increase in progression-free survival in previously untreated patients with chronic lymphocytic leukemia,” said Kirsten Fischer, investigator in the CLL14 study at University Hospital Cologne. 

 

“Importantly, with a demonstrated median time to next treatment of approximately eight years, the findings reflect the sustained durability of this combination treatment option with a meaningful time without CLL specific treatment for patients.”

 

The venetoclax-obinutuzumab regimen delivered a median progression-free survival of 6.4 years, compared with 3.2 years in the control arm, reinforcing a sustained benefit nearly a decade after treatment initiation.

 

Patients also experienced a median time to next treatment of 7.6 years, underscoring what researchers describe as a prolonged “treatment-free interval” following a one-year fixed-duration therapy.

 

Safety findings remained consistent with known profiles. The most frequently reported Grade 3 or higher adverse events included neutropenia, thrombocytopenia, infusion-related reactions, anemia, febrile neutropenia, pneumonia, and leukopenia.

 

The CLL14 trial enrolled 432 previously untreated patients with CLL and coexisting medical conditions, comparing fixed-duration venetoclax plus obinutuzumab against chlorambucil-based therapy. Results consistently favored the venetoclax regimen across progression-free survival, response rates, and long-term durability endpoints.

 

Researchers emphasized that the benefit persisted well beyond the treatment period, reinforcing the clinical rationale for time-limited therapy in selected patients.