Abstract
The pharmacokinetics (PK) and safety of ofatumumab and bendamustine alone and in combination were evaluated in patients with treatment-naive or relapsed indolent B-cell non-Hodgkin lymphoma (iNHL). Patients were randomly assigned to ofatumumab and bendamustine or ofatumumab alone. Ofatumumab PK concentration profiles and parameters were similar, alone or in combination with bendamustine. A decrease of 14% in the maximum observed plasma concentration (Cmax) and 15% in the area under the plasma concentration–time curve (AUC) from time 0 to the last measurable concentration sampling time (AUClast) was observed for ofatumumab coadministered with bendamustine, which was not considered clinically relevant. Bendamustine PK concentration profiles and parameters were similar with or without ofatumumab. The most frequent treatment-related adverse event was infusion-related reaction in 53% in the combination arm and 47% in the ofatumumab arm. No relevant drug-drug interaction was observed between ofatumumab and bendamustine. Ofatumumab alone or in combination with bendamustine had a manageable safety profile.
Original language | English (US) |
---|---|
Pages (from-to) | 1099-1109 |
Number of pages | 11 |
Journal | Clinical Pharmacology in Drug Development |
Volume | 11 |
Issue number | 9 |
DOIs | |
State | Published - Sep 2022 |
Keywords
- bendamustine
- clinical trial
- drug-drug interaction
- iNHL
- ofatumumab
- pharmacokinetics
ASJC Scopus subject areas
- Pharmaceutical Science
- Pharmacology (medical)