Tumor Response Data in 300 and 500 mg Dose Groups

Copenhagen, Denmark; December 4, 2004 – Genmab A/S (CSE: GEN) announced today that 55% of patients (6 of 11) with relapsed or refractory follicular Non-Hodgkin’s Lymphoma (NHL) treated with HuMax™-CD20 achieved a clinical response in the Phase I/II study, including two complete responses and one unconfirmed complete response for a 27% complete response rate. These responses were observed in 11 evaluable patients among the first 15 of the 40 patients included in this study at the week 11 evaluation point. 

Patients in the 300 and 500 mg dose groups were assessed for clinical response at week 11, 8 weeks after their fourth and final dose of HuMax-CD20 and data was available for two patients at week 19.  In the 300 mg dose group, 57%, four of seven patients, achieved a clinical response including two complete responses and two partial responses. One patient maintained the complete response at week 19. One patient with a partial response at week 11 achieved an unconfirmed complete response at week 19.  In the 500 mg dose group, two of four patients achieved a clinical response, one patient achieved a partial response and one achieved an unconfirmed complete response. Confirmation of one complete response by bone marrow biopsy is pending. All computerized tomography (CT) images are evaluated centrally by an independent radiologist.

The 300 mg, 500 mg and 700 mg dose levels caused profound depletion of B-cells, which are responsible for the growth of tumors in NHL patients.

No dose limiting toxicity has been reported with administration of HuMax-CD20 up to a dose of 1000 mg per week.  Six grade 3 adverse events considered related to HuMax-CD20 were reported in five patients.  Four patients were reported as having hypotension, dysponea and pruritus. In addition, one patient in the 500 mg group was withdrawn during the first infusion due to grade 3 dyspnoea and laryngeal edema due to  cytokine release considered related to the administration of HuMax-CD20. Twenty-five patients reported predominantly brief grade 1 and 2 adverse events with onset on infusion days consisting of symptoms of cytokine release such as pruritius, dyspnoea, rigors/chills, nausea, hypotension, urticaria, fatigue, fever and rash. 

“The significant responses of NHL patients in this study are very encouraging and we are pleased to see that HuMax-CD20 seems to have a very good safety profile,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. 

The data is being presented today at the 46th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California by Anton Hagenbeek, Professor of Hematology at the University Medical Center Utrecht. The poster can also been seen at www.genmab.com

About the trial

In the Phase I/II dose escalation trial, 40 patients divided into four dose cohorts received intravenous infusions of HuMax-CD20 at doses of 300, 500, 700, or 1000 mg once weekly for four weeks and will be followed for 12 months.  Forty patients have been assessed for dose-limiting toxicities and 27 patients for safety in the study thus far and results for all patients will be presented at a later date.  The primary endpoint of the study is clinical response at week 19 according to the Cheson criteria.

Cheson criteria

The Cheson criteria were developed by the National Cancer Institute and the international pharmaceutical industry to provide a guideline for assessing clinical response in NHL.  According to the criteria, a complete response is obtained when there is a complete disappearance of all detectable clinical and radiographic evidence of disease and disease related symptoms, all lymph nodes have returned to normal size, the spleen has regressed in size, and the bone marrow is cleared of lymphoma.  An unconfirmed clinical response is obtained when a patient shows complete disappearance of the disease and the spleen regresses in size, but lymph nodes have regressed by more than 75% and the bone marrow is indeterminate.  For a partial response, there must be a 50% decrease in size of the six largest dominant lymph nodes, no increase in size of the other nodes, liver or spleen, splenic, hepatic nodules must regress by at least 50% and there must be no new disease sites.

Conference Call

A conference call will be held to discuss this news on Monday, December 6 at

4:00 pm CET

3:00 pm GMT

10:00 am EST

The conference call will be held in English.

The dial in numbers are as follows:

+1 800 946 0782 (in the US) and ask for the Genmab conference call

+1 719 457 2657 (outside the US) and ask for the Genmab conference call