• IRC-assessed ORR, nPR, and PR, as well as INV-assessed ORR, CR/CRi, INV duration of response (DoR), event-free survival (EFS), and time to next CLL treatment were not tested for statistical significance
  • The differences observed for the IRC-assessed CR+CRi rates in the VEN+R and BR treatment arms were not statistically significant 4
  • Response rates were assessed per 2008 iwCLL NCI-WG guidelines 1
  • INV-assessed ORR was 93% (n=181; 95% CI: 89-96) for VEN+R, including 27% (n=52) CR/CRi, and 68% (n=132; 95% CI: 61-74) for BR, including 8% (n=16) CR/CRi 12
    • INV-assessed vs IRC-assessed CR/CRi discordance was primarily due to interpretation of residual adenopathy on CT scans; specifically, 33 out of 51 total discordant patients had lesions ≤3 cm across both arms, despite marrow clearance 4,5
  • The INV-assessed median DoR was not reached in the VEN+R arm and was 19.4 months (95% CI: 16.1-22.6) in the BR arm 13

*Defined as the time from randomization to the date of disease progression or relapse, death from any cause, or the start of a new therapy for CLL.

ORR=overall response rate; CR=complete remission; CRi=complete remission with incomplete marrow recovery; nPR=nodular partial remission; PR=partial remission; CI=confidence interval; iwCLL=International Workshop on Chronic Lymphocytic Leukemia; NCIWG=National Cancer Institute–sponsored Working Group; INV=investigator; CT=computed tomography; BR=bendamustine + rituximab.