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
![81% reduction in risk of progression or death vs BR (HR=0.19; 95% CI: 0.13-0.28 [P<0.0001]). After a median follow-up of 23.4 month (range: 0-37.4+ months): There were 35 events in the VEN+R arm (26 progressions and 9 deaths occuring without progression) compared with 106 events in the BR arm (91 progressions and 15 deaths occuring without progression). The median PFS was not reached (NR) with VEN+R vs 18.1 months (95% CI: 15.8-22.3) with BR](/content/dam/gene/venclextahcp-fullsite/images/venclexta-cll-rr-81-primary-endpoint-os-desktop.jpg)
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.
