Genmab announces early results of ongoing HuMax-CD4 trials

12-Dec-2006

Genmab A/S announced positive early results of the first stage of the ongoing pivotal Phase III study of HuMax-CD4® (zanolimumab) in cutaneous T-cell lymphoma (CTCL) and the ongoing Phase II study in non-cutaneous T-cell lymphoma (NCTCL). In the pivotal CTCL study, clinical response was shown in 5 of 12 patients (42%) in the two highest dose groups. A partial response was obtained by 1 of 6 patients (16%) in the 8 mg/kg dose group and 4 of 6 patients (67%) 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.

A total of 22 patients were enrolled in three dose cohorts in the first part of the pivotal study and received infusions of 4, 8, or 14 mg/kg of HuMax-CD4 once weekly for 12 weeks. Patients were evaluated 4 and 8 weeks after the final treatment dose and every 8 weeks until progression of disease. 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 N. Drakeman, Ph. D., Chief Executive Officer 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 (NCTCL) showed that 4 of 14 patients (28.5%) had objective responses. Plans are ongoing to next test HuMax-CD4 in combination with chemotherapy for the NCTCL patients.

https://www.bionity.com/en/news/60068/genmab-announces-early-results-of-ongoing-humax-cd4-trials.html