Genmab initiates ofatumumab frontline NHL study
- Category: Antibodies
- Published on Monday, 18 June 2007 04:00
- Hits: 1653
COPENHAGEN, Denmark | June 14, 2007 | Genmab A/S (CSE: GEN) announced today it has initiated a Phase II study of ofatumumab (HuMax-CD20®) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in patients with previously untreated follicular non-Hodgkin’s lymphoma (NHL). A total of 56 patients will be enrolled in the study which is being conducted under Genmab’s collaboration with GlaxoSmithKline.
“We are pleased to begin this study of ofatumumab for front line treatment of follicular NHL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab, “which we hope may be more effective than currently available treatment.”
About the trial
Patients in this open label study will be randomized into two dose groups of 28 patients each and will receive 6 infusions of ofatumumab in combination with CHOP. Each patient will receive 300 mg of ofatumumab at the first infusion, followed by 5 subsequent infusions of either 500 or 1000 mg of ofatumumab every 3 weeks, in combination with 6 cycles of CHOP. Disease status will be assessed at three months following the last treatment and then every three months until month 24, and every 6 months thereafter until 60 months or initiation of alternative treatment.
The objective of the study is to determine the efficacy of two dose regimens of ofatumumab in combination with CHOP in previously untreated follicular NHL patients. The primary endpoint in the study is objective response from start of treatment until 3 months after last treatment assessed according to the standardized response criteria for NHL at 30 weeks.
SOURCE: Genmab A/S