Venetoclax plus rituximab may prolong progression-free survival (PFS) compared with bendamustine plus rituximab in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), according to results from a phase 3 study.1

In the MURANO study (ClinicalTrials.gov Identifier: NCT02005471), researchers randomly assigned 389 patients with R/R CLL who were previously treated with at least 1 but not more than 3 lines of therapy to receive rituximab with venetoclax or bendamustine.

The primary endpoint of the study was investigator-assessed PFS, and secondary endpoints included Independent Review Committee (IRC)-assessed PFS, PFS in patients with 17p deletion, overall survival, event-free survival, best overall response (defined as complete response [CR], complete response with incomplete marrow recovery [CRi], nodular partial remission [nPR], or PR), duration of response, time to next anti-CLL treatment, and percentage of patients achieving minimal residual disease negativity.

AbbVie, the co-developer of venetoclax, announced that study’s primary endpoint was met. Full results and data from the MURANO study will be presented at an upcoming conference.

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Venetoclax was previously granted accelerated approval by the US Food and Drug Administration for the treatment of patients with the 17p deletion CLL, and also received Breakthrough Therapy Designation for the treatment of patients with R/R CLL in combination with rituximab.

Reference

  1. AbbVie announces positive topline results from phase 3 trial evaluating VENCLEXTA™/VENCLYXTO™ (Venetoclax) tablets in combination with Rituxan® (rituximab) for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia [news release]. North Chicago, IL: AbbVie; September 18, 2017. https://news.abbvie.com/news/abbvie-announces-positive-topline-results-from-phase-3-trial-evaluating-venclextavenclyxto -venetoclax-tablets-in-combination-with-rituxan-rituximab-for-treatment-patients-with-relapsedrefractory-chronic-lymphocytic-leukemia.htm. Accessed September 18, 2017.