ARZERRA Plus Chlorambucil Demonstrated a Statistically Significant 71% Improvement in Median PFS (22.4 Months vs 13.1 Months) Compared With Chlorambucil Alone (P<0.001)1

Efficacy Was Assessed According to iwCLL Criteria by an IRC1


  • Significantly improved median PFS by 9.3 months vs chlorambucil alone1
  • Median PFS of 22.4 months for ARZERRA plus chlorambucil vs 13.1 months for chlorambucil alone (HR 0.57 [95% CI: 0.45, 0.72] P<0.001)1
  • PFS was consistent across a range of patient types, including those with poor-risk biological features (such as 17p or 11q deletion, unmutated IGHV, β2M >3500 µg/L, and ZAP-70 expression)
  • Based on a median follow-up of 28.9 months2

Time to Next Treatment Increased to Almost 40 Months in the ARZERRA Plus Chlorambucil Arm Compared With Approximately 25 Months for Chlorambucil Alone2

IRC-Assessed Median Time to Next Treatmenta

  • Significantly greater median time to next treatment with ARZERRA plus chlorambucil vs chlorambucil alone (39.8 vs 24.7 months, P<0.0001)
aTime to next treatment is calculated from the start of ARZERRA plus chlorambucil treatment to the initiation of second-line treatment.
β2M, beta-2 microglobulin; HR, hazard ratio; IGHV, immunoglobulin variable region heavy chain; IRC, independent review committee; iwCLL, International Workshop on Chronic Lymphocytic Leukaemia; PFS, progression-free survival; ZAP-70, zeta-chain-associated protein kinase 70.

Learn more about the study design and patient characteristics.

References: 1. Arzerra® (ofatumumab) summary of product characteristics. West Sussex, UK; Novartis Europharm Limited; 2016. 2. Hillmen P, Robak T, Janssens A, et al, for the COMPLEMENT 1 Study Investigators. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet. 2015;385(9980):1873-1883.