Results are from the first stage of an ongoing phase III study of HuMax-CD4 in cutaneous T-cell lymphoma (CTCL) and an ongoing phase II study in non-cutaneous T-cell lymphoma (NCTCL).
In the study, clinical response was shown in 42% of patients in the two highest dose groups. A partial response was obtained by 16% in the 8 mg/kg dose group and in 67% of patients in the 14 mg/kg dose group. Patients were also treated at the 4 mg/kg dose level, with no responses observed. This dose level is not being used in the second part of the ongoing pivotal study.
The goal of this first portion of the phase III study was to characterize material obtained from a new manufacturing site.
“We have successfully characterized the new HuMax-CD4 material and have moved into the second phase of the CTCL pivotal study,” said Lisa Drakeman, CEO of Genmab.
“We are encouraged by the response rates in these patients who have failed other therapies.”
Preliminary results in the ongoing phase II clinical trial in HuMax-CD4 to treat non-cutaneous T-cell lymphoma showed that 28.5% of patients had objective responses. Plans are ongoing to next test HuMax-CD4 in combination with chemotherapy for the NCTCL patients.