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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