Aggregated Safety Profile for ARZERRA in the Treatment of Previously Untreated, Relapsed, and FA-Refractory CLL1

Safety Population

The overall safety profile of ARZERRA is based on data from 1,168 patients in clinical trials. This includes:

  • 643 patients treated with ARZERRA as monotherapy (in patients will relapsed or refractory CLL)
  • 525 patients treated with ARZERRA in combination with chemotherapy (chlorambucil or bendamustine or fludarabine and cyclophosphamide)

Adverse Reactions for ARZERRA, Either Alone or in Combination With Chemotherapy1,a,b

aThese events are likely attributable to ofatumumab in the setting of an infusion reaction and typically occur after the start of infusion and within 24 hours after the completion of the infusion.
bDefinition of frequency: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000).
PFS, progression-free survival; TTNT, time to next treatment.

Selected Adverse Reactions Across Trials and Populations1

  • Infusion-related reactions:
    • IRRs were the most frequently reported AEs, occuring in 61% (711/1,168) of patients at any time during treatment
    • The majority of IRRs were grades 1 or 2; 7% of patients had grade ≥3 IRRs at any time during treatment
    • 2% of the infusion reactions led to discontinuation of treatment
    • There were no fatal infusion reactions in the clinical trials
  • Infections (bacterial, viral, or fungal) were experienced by 58% (682/1,168) of patients
    • 23% (268/1,168) of patients had grade ≥3 infections
    • 6% (65/1,168) of patients had a fatal infection
  • Neutropenia-related AEs were experienced by 36% (420/1,168) of patients
    • 11% (129/1,168) experience a serious adverse event associated with a decreased neutrophil count

Summary of Adverse Events for ARZERRA Plus Chlorambucil and Chlorambucil Alone in Previously Untreated CLL Patients2

Rates of AEs and AE-Related Discontinuations

Hematologic AEs

Infection Rates

IRRs were mostly mild to moderate and manageable2

  • 67% of patients experienced IRRs, mostly in cycles 1 and 2
  • 10% of patients experienced grade ≥3 IRRs at any time during treatment
  • 3% of patients discontinued treatment due to IRRs
    • There were no fatal infusion reactions reported
AE, adverse event; CLL, chronic lymphocytic leukemia; FA, fludarabine and alemtuzumab; IRR, infusion-related reaction; MedDRA, Medical Dictionary for Regulatory Activities.

View efficacy data for ARZERRA in the first-line treatment of CLL.

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.