Copenhagen, Denmark; December 1, 2005 – Genmab A/S (CSE: GEN) announced today additional positive results in the HuMax-CD20 Phase I/II study to treat patients with relapsed or refractory follicular non-Hodgkin’s lymphoma (NHL). 

Overall, there were 37 evaluable patients and objective response rates at each dose level in this safety study were 63% (300 mg), 33% (500 mg), 20% (700 mg) and 60% (1000 mg) for an overall response rate of 43%, according to the Cheson criteria.  These response rates include 5 complete responses (CR), 2 complete responses unconfirmed (CRu) and 9 partial responses (PR).  A CRu meets and exceeds the criteria for partial response.

Responders include one additional patient compared to the data previously reported in June.

The new responding patient had previously responded to rituximab.  This increases the objective response rate in patients who previously responded to rituximab treatment to 64% (9 of 14 patients), including 3 CR, 1 CRu and 5 PR.

The median duration of response and median time to disease progression in responding patients have not yet been reached after 12 months of follow up.  Of the 16 patients who responded to treatment, 12 have not progressed at the end of the follow up period.

HuMax-CD20 was well tolerated by the patients in the study.  No dose limiting toxicities were reported and the maximum tolerated dose was not reached.

“We are particularly encouraged by the response rate in relapsed patients and look forward to the ongoing development of HuMax-CD20 in follicular lymphoma,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

About the trial

The Phase I/II dose escalation trial was designed for 40 patients divided into 4 dose cohorts to receive intravenous infusions of HuMax-CD20 at doses of 300, 500, 700 or 1000 mg once weekly for 4 weeks and were followed for 12 months.  Thirty-seven patients were evaluable.  Patients in this study had relapsed or refractory follicular lymphoma and have previously received a median of 2 treatment regimens, including the possibility of rituximab.