Pharmacokinetics and pharmacokinetic/pharmacodynamic associations of ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or refractory chronic lymphocytic leukaemia: a phase 1-2 study

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BlankPharmacokinetics and pharmacokinetic/pharmacodynamic associations of

ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or

refractory chronic lymphocytic leukaemia: a phase 1-2 study.

B Coiffier, N Losic, BB Ronn, S Lepretre, LM Pedersen, O Gadeberg, H

Frederiksen, MH van Oers, J Wooldridge, J Kloczko, J Holowiecki, A Hellmann, J

Walewski, T Robak, and J sen

Br J Haematol, April 16, 2010;

Departement d'H?matologie, Centre Hospitalier Lyon Sud, Pierre-Benite Cedex,

France.

Summary The purpose of this phase 1-2 study was to investigate the association

between the pharmacokinetic properties of ofatumumab, a human monoclonal CD20

antibody, and outcomes in 33 patients with relapsed/refractory chronic

lymphocytic leukaemia receiving 4 weekly infusions of ofatumumab. The ofatumumab

concentration profiles were fitted well by a two-compartment model with

different elimination rate constant at first infusion compared to the remaining

infusions in line with the observed rapid and sustained B-cell depletion.

Exposure to ofatumumab was linked to clinical outcomes: high exposure was

associated with higher probability of overall clinical response and longer

progression-free survival. This association still remained statistically

significant even when adjusting for relevant baseline covariates including

tumour burden. The trial was registered at http://www.clinicaltrials.gov

(NCT00093314).

PMID: 20408846

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