5-year overall survival

MURANO: In a randomized (1:1), multicenter, actively controlled, open-label, phase 3 trial (MURANO), VEN+R was studied against bendamustine in combination with rituximab (BR) in 389 patients with CLL who had received at least one line of prior therapy. The primary endpoint was progression-free survival. See full study design. 1,6

IRC-assessed PFS (primary endpoint) 1

OS: 5-year post hoc analysis 12

  • The post hoc analysis was not tested for statistical significance
  • The rates shown for 5-year overall survival are estimates and can be unreliable due to the large number of patients censored at the tail portion of the curve

*Clinical cutoff date: May 8, 2020.

A survival analysis was performed at the 5-year follow-up

  • Median OS was not reached in either arm
  • The rates of death were 17% (n=32) in the VEN+R arm and 33% (n=64) in the BR arm
    • HR=0.40; 95% CI: 0.26-0.62
  • These data are currently under evaluation by the FDA

Treatment after VEN+R at the 4-year follow-up

In a 4-year follow-up analysis of the VEN+R patient cohort, 42 (22%) of 194 patients received subsequent therapy with modalities that included: BTK inhibitor (n=12), BCL-2 inhibitor (n=14), PI3K inhibitor (n=1), CIT (n=14), and other (n=1). 17

  • Among the 12 patients treated with a BTK inhibitor, 10 patients achieved a response and 2 patients were not evaluable

VEN+R=VENCLEXTA + rituximab; IRC=Independent Review Committee; BR=bendamustine + rituximab; HR=hazard ratio; CI=confidence interval; OS=overall survival; BTK=Bruton's tyrosine kinase; PI3K=phosphoinositide 3-kinase; CIT=chemoimmunotherapy.

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