Phase III MURANO trial of Venclexta + Rituxan shows detection limits of disease in chronic lymphocytic leukemia.- AbbVie/Roche/Genentech.

AbbVie announced the presentation of investigational data from a new analysis of undetectable minimal residual disease (uMRD) rates from the pivotal Phase III MURANO trial of Venclexta + Rituxan (venetoclax + rituximab), or VenR, in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). Of the 121 patients who achieved uMRD (meaning less than one CLL cell in 10,000 white blood cells were detectable using a standardized test2) at the end of combination therapy (EOCT), 83 percent (n=100) maintained uMRD and were progression-free for a median of 13.8 months (range, 5.6-23.0 months) thereafter.

A high peripheral blood (PB) /bone marrow (BM) MRD concordance was seen with VenR in patients with paired samples (84 percent). Achievement of uMRD was independent of risk factors, including del(17p), IgVH mutation and TP53 mutations. Eighty-three percent of VenR patients who attained uMRD at EOCT maintained this status and were progression-free for a median of 13.8 months (range, 5.6-23.0 months) after EOCT. These results will be presented during the 23rd European Hematology Association (EHA) Annual Congress.

Comment: Data from the MURANO study will be submitted to global health authorities, including the FDA, which has granted Breakthrough Therapy Designation for Venclexta in combination with Rituxan for the treatment of relapsed or refractory CLL based on promising results from the Phase Ib M13-365 study.