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news.Genmab has initiated a pivotal study evaluating the efficacy of its Humax-Cd20 in the treatment of follicular non-Hodgkin's lymphoma patients who are refractory to rituximab.
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The pivotal study will include approximately 162 non-Hodgkin’s lymphoma (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 Dr Lisa Drakeman, CEO 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 300mg of HuMax-CD20 followed by seven weekly infusions of either 500mg or 1000mg of HuMax-CD20. Disease status will be assessed every three 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 six-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.