Genmab A/S has initiated a pivotal study to treat follicular non-Hodgkin's lymphoma (NHL) patients who are refractory to rituximab.
The pivotal study will include approximately 162 NHL patients who are refractory to rituximab in combination with chemotherapy or to rituximab given as maintenance treatment.
"NHL is the second indication to enter a pivotal study for HuMax-CD20," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "We now have two possible pathways to initial approval for HuMax-CD20 targeting two different disease indications."
Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month 24.
The objective of the study is to determine the efficacy and safety of two dose regimens of HuMax-CD20. The primary endpoint of the study is objective response as measured over a 6 month period from start of treatment assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for non-Hodgkin's lymphomas.