1L
VEN+G demonstrated durable PFS after stopping treatment at 12
months 1
CLL14: 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 or CLcr <70 mL/min). The primary endpoint was progression-free survival (PFS). See full study design.
IRC-assessed PFS (primary endpoint) 1
- After a median follow-up of 28 months (range: 0-36 months),
there were 29 events (14 progression and 15 death events) in the
VEN+G arm compared with 79 in the GClb arm (71 progression and 8
death events).* Median PFS was not reached in either arm
36-month post hoc analysis of INV-assessed PFS 9†
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: 0.22-0.44)
- 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 1,9* -
Overall survival: In a post hoc analysis (39.6-month median
follow-up), overall survival was not sufficiently mature for
evaluation, with 27 events in the VEN+G arm and 27 events in the
GClb arm
The National Comprehensive Cancer Network® (NCCN®) recommends venetoclax (VENCLEXTA®) in combination with obinutuzumab as a preferred regimen for the treatment of 1L CLL/SLL patients with or without 17p deletion. 11§
*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.
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R/R
VEN+R demonstrated durable PFS after stopping treatment at ~24 months 1
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.
IRC-assessed PFS (primary endpoint) 1
48-month post hoc analysis of PFS (INV-assessed) 10*
The post hoc analysis was not tested for
statistical significance.
- Median PFS was estimated to be 52.3 months‡ (95% CI: 47.9-NE) with VEN+R and was 17.1 months (95% CI: 15.7-22.1) for BR (HR=0.19; 95% CI: 0.14-0.25)
- Of the 78 events in the VEN+R arm, 14 were death and 64 were disease progression. Of the 160 events in the BR arm, 18 were death and 142 were disease progression
- Landmark PFS at 18 months post-treatment for patients who completed VEN+R (n=130) was 76% (95% CI: 67-84). Median time off treatment was 22.2 months (95% CI: 19.8-22.7)§
The National Comprehensive Cancer Network® (NCCN®) recommends venetoclax (VENCLEXTA®) in combination with rituximab as a Category 1 preferred regimenII for the treatment of R/R CLL/SLL patients with or without 17p deletion. 11
*2-year data update based on data as of clinical
data cutoff date of May 8, 2019.
†2-year and 4-year
PFS estimates were not prespecified and were 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 (not prespecified and
not powered to demonstrate statistically significant
differences).
IISee NCCN Guidelines® for
the NCCN definitions of Categories of Preference and Categories of
Evidence and Consensus.
NE=not estimable; SLL=small lymphocytic lymphoma.