Genentech announces new data reinforcing the long-term benefit of Venclexta-based combinations for relapsed or refractory chronic lymphocytic leukemia.

Genentech, a member of the Roche Group announced that new data from the pivotal Phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta (venetoclax)-based combinations in certain people with chronic lymphocytic leukemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD). Data were presented at the all-virtual 62 nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday, December 5, 2020. Five-year data from the pivotal Phase III MURANO trial: continue to show sustained investigator-assessed progression-free survival (PFS) with Venclexta plus Rituxan (rituximab). Data, presented in an oral session, showed: Venclexta plus Rituxan reduced the risk of disease progression or death by 81% (HR=0.19; 95% CI: 0.15, 0.26; p<0.0001) compared to bendamustine plus rituxan (br) in people with relapsed or refractory (r r) cll. at the time of analysis, median overall survival (os) had not been reached in either arm (hr="0.40;" 95% ci: 0.26, 0.62), however, five-year os was 82.1% in the venclexta plus rituxan arm, compared to 62.2% in the br arm. in the venclexta arm, among the 130 patients who completed two years of treatment without progressive disease, 63.8% (n="83/130)" had undetectable mrd (umrd) levels at the end of treatment. in an analysis of this patient subgroup, umrd (minimal residual disease) was associated with improved progression-free survival. undetectable mrd, sometimes referred to as mrd-negativity, means that no cancer cells could be detected using a specific and highly sensitive test, and is defined as less than one cancer cell in 10,000 leukocytes. no new safety events were reported in the study. data from the phase iii cll14 study : contributes to growing evidence regarding the potential of mrd measurements to predict future outcomes for certain people with previously untreated cll who were treated with fixed-duration venclexta plus gazyva (obinutuzumab): patients with umrd and a partial response (pr) had longer pfs than patients with detectable mrd and a complete response (cr). in collaboration with adaptive biotechnologies, clonal growth rate, a measure for how quickly cancer cells grow, was analyzed using the next-generation sequencing adaptive clonoseq assay and insights were used to better understand the potential role of mrd in predicting outcomes. in this analysis, after treatment with fixed-duration venclexta plus gazyva, the estimated clonal growth rate was slower and lower, suggesting more effective mrd eradication in these patients compared to those treated with gazyva plus chlorambucil. early data suggest a correlation between mrd responses and pfs, which will be further evaluated by the study authors. exploring novel endpoints, such as mrd, is an important area of development for genentech, which continues to investigate venclexta in a robust clinical development program. this includes the phase iii cristallo trial in previously untreated cll, which uses mrd as a primary endpoint. venclexta is being developed by abbvie and genentech, a member of the roche group. it is jointly commercialized by the companies in the united states and commercialized by abbvie outside of the united states. minimal residual disease (mrd) is a measure of the number of remaining cancer cells. undetectable mrd (umrd), sometimes referred to as mrd-negativity, means that no cancer cells could be detected using a specific and highly sensitive test, and is defined as less than one cancer cell in 10,000 leukocytes.>