VEN+G demonstrated durable PFS after stopping treatment at 12 months 1
In a randomized (1:1), multicenter, actively controlled, open-label, phase 3 trial (CLL14), VEN+G was studied against GClb in 432 patients with previously untreated CLL with comorbid medical conditions (total CIRS score >6 of CLcr <70 mL/min). The primary endpoint was progression-free survival (PFS). See full study design.
IRC-assessed PFS (primary endpoint)
- After a median follow-up of 28 months (range: 0.1-36 months), there were 29 events (71 progression and 8 death events).* Median PFS was not reached in either arm
The post hoc analysis was not tested for statistical significance.
- With a median follow-up of 39.6 months (range: 0-47.3 months),
median PFS was not reached in the VEN+G arm and was estimated to be
35.6 months (95% CI: 33.7-40.7) in the GClb arm (HR=0.31; 95% CI:
- Of the 42 events in the VEN+G arm, 21 were death and 21 were disease progression. Of the 113 events in the GClb arm, 11 were death and 102 were disease progression 30*
*Number of events based on earliest event of
disease progression or death due to any cause. Events due to
progression may include deaths occurring post-progression.
†1-year update from primary analysis based on data as of clinical data cutoff date of August 23, 2019.
‡The 1-year and 3-year PFS estimates were not prespecified and were not tested for statistical significance.
§See NCCN Guidelines® for the NCCN definitions of Categories of Preference and Categories of Evidence and Consensus.
VEN+G=VENCLEXTA (venetoclax tablets) +
GAZYVA® (obinutuzumab); PFS=progression-free-survival;
IRC=Independent Review Committee; INV=investigator; GClb=GAZYVA +
chlorambucil; HR=hazard ratio; CI=confidence interval; OS=overall
survival; CLcr=creatinine clearance; CIRS=Cumulative Illness Rating
VEN+R demonstrated durable PFS with ~24 months* of treatment 1,12
In a randomized, multiceneter, open-label, phase 3 trial (MURANO), VEN+R was studied against BR in 389 patients with CLL who had received at least one line of prior therapy. The primary endpoint was progression-free survival (PFS). 1 See full study design.
- After a median follow-up
of 23.4 months (range: 0-37.4+ months) 1:
- There were 35 events in the VEN+R arm (26 progression and 9 death events) compared with 106 events in the BR arm (91 progression and 15 death events) 1
- The median PFS was not reached (NR) with VEN+R vs 18.1 months (95% CI: 15.8-22.3) with BR 1
- The estimated 24-month PFS was 83% (95% CI: 77-89) for VEN+R vs 39% (95% CI: 31-48) for BR 12
*From Cycle 1, Day 1 of rituximab.
†Censoring for missing PFS assessments, ITT.
‡Estimated 24-month PFS rate was not prespecified and was not tested for statistical significance.
§HR estimate is based on Cox proportional hazards model stratified by 17p deletion, risk status, and geographic region; P value is based on log-rank test stratified by the same factors.
48-month post hoc analysis of PFS after stopping treatment at ~24 months13
- Not tested for statistical significance
- The median follow-up was 47.9 months (range: 0-60.1 months), and there were 78 events in the VEN+R arm and 160 events in the BR arm
- Median PFS was estimated to be 52.3 months‡ (95% CI: 47.9-NE) in VEN+R and 17.1 months (95% CI: 15.7-22.1) for BR [HR=0.19; CI: 0.14-0.25]
- Four-year PFS estimates were 57% (95% CI: 49-65) and 5% (95% CI: 0-9) for VEN+R and BR, respectively
*2-year data update, based on data as of clinical
data cutoff date of May 8, 2019.
†Estimated 48-month PFS rate was not prespecified and was not tested for statistical significance.
‡Median PFS for VEN+R exceeds median follow-up.
§54 patients completed the 18-month post-treatment follow-up visit.
IISee NCCN Guidelines® for the NCCN definitions of Categories of Preference and Categories of Evidence and Consensus.
VEN+R=VENCLEXTA (venetoclax tablets) + rituximab;
PFS=progression-free survival; IRC=Independent Review Committee;
BR=bendamustine + rituximab; HR=hazard ratio; CI=confidence
interval; OS=overall survival; NE=not estimable.