AbbVie has presented new long-term data, further supporting the sustained clinical benefit of fixed duration treatment with Venclexta (Ingredient: venetoclax) in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL).
AbbVie's chronic lymphocytic leukemia treatment Venclexta
The updated four-year analysis data from the phase 3 MURANO trial showed that patients with R/R CLL who completed the chemotherapy-free, two-year fixed duration course of Venclexta treatment combination maintained progression-free survival (PFS) and overall survival (OS).
Patients who completed treatment with the Venclexta combination also achieved higher rates of minimal residual disease (MRD)-negativity and complete remissions compared to those treated with the standard care of bendamustine plus rituximab.
MRD-negativity is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.
The full results were presented during the recent annual conference of 61st American Society of Hematology (ASH).
"These results support the benefits of a fixed duration of treatment with venetoclax to reduce the risk of disease progression or death in patients with chronic lymphocytic leukemia," said Mohammed Zaki, AbbVie vice president and global head of hematology development. "We remain committed to understanding the full utility of venetoclax combinations and to advancing other clinical development programs with the potential to transform the standards of care for patients with blood cancers."
Professor John Seymour, the lead investigator for the MURANO trial, also said. "In the four-year analysis from the MURANO trial, treatment with the venetoclax combination resulted in an 81 percent reduction in the risk of progression or death compared to the standard of care."
The sustained efficacy and manageable safety profile observed in the study further support the clinical benefits of fixed treatment in patients with relapsed or refractory chronic lymphocytic leukemia, Seymour added.
In the long-term analysis, the median follow-up for patients who completed two years of treatment with the venetoclax combination without progressive disease was 22 months. PFS and OS lasted longer for patients taking Venclexta plus rituximab compared to those receiving bendamustine plus rituximab.
Also, 24 months after patients were off therapy, the investigator-assessed estimated PFS was 57.3 percent for Venclexta plus rituximab versus estimated PFS of 4.6 percent in patients taking bendamustine plus rituximab.
Additionally, the OS analysis showed a four-year event-free rate of 85.3 percent in the Venclexta plus rituximab arm compared to 66.8 percent for bendamustine plus rituximab.
The improvements in both PFS and OS were observed, although 79 percent of patients in the control arm received an additional targeted CLL treatment after disease progression.
By the end of treatment, 64 percent of patients achieved MRD-negativity, and 87 percent of those patients remained free of disease progression two years post-treatment.
The safety profile of the combination is consistent with the known safety profile of each individual therapy alone.
<© Korea Biomedical Review, All rights reserved.>