Clinical Efficacy and Time to Progression Correlate to HuMax-CD20 Treatment

Copenhagen, Denmark; December 11, 2006 – Genmab A/S (CSE: GEN) announced today additional positive results in the HuMax-CD20™ (ofatumumab) Phase I/II study to treat patients with relapsed or refractory chronic lymphocytic leukemia (CLL). An objective response rate of 50% (13 of 26 evaluable patients) was observed in patients treated at the highest dose level (2000 mg). This included one nodular partial remission (nPR) confirmed by CT scan and one patient who qualified as nPR but had residual lymphadenopathy revealed by CT.

Responders include one additional patient compared to previously reported data.

The median time to disease progression in all patients treated at 2000 mg was approximately 16 weeks ranging from 15 to 23 weeks. In the patients responding to HuMax-CD20 treatment, the median time to disease progression was 23 weeks ranging from 20 – 31 weeks. The median time to next anti-CLL treatment was 52 weeks. These survival endpoints correlated statistically to the patients’ total exposure to HuMax-CD20 over time and to the clearance of the antibody.

“The CLL patients in this study appear to have benefited from treatment with HuMax-CD20.  These data strongly support further development of HuMax-CD20 in CLL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer at Genmab. 

These results are being presented at poster session #2842 on December 11 from 10:30AM to 7PM local time in Hall E1 West, board 71-III at the 48th Annual American Society of Hematology Annual Meeting and Exposition in Orlando, Florida. 

About the study

The study is an open-label dose escalation trial that enrolled 33 patients who had failed previous therapy. The trial has three dose levels.  Three patients at the first dose level received an initial dose of 100 mg followed by three weekly doses of 500 mg; at the second dose level three patients received a dose of 300 mg followed by three weekly doses of 1,000 mg; and at the third level, 27 patients received an initial dose of 500 mg followed by three weekly doses of 2,000 mg.

The total follow up period for this study is 12 months from treatment start and the primary endpoint of the trial is objective response over the period from screening to week 19. An objective response is one that lasts at least 8 weeks by the NCI working group guidelines for CLL.