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HuMax-CD20 shows favourable clinical responses in NHL: Genmab
Copenhagen, Denmark | Tuesday, December 7, 2004, 08:00 Hrs  [IST]

Genmab A/S announced that 55 per cent of patients 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 per cent 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 per cent, 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, according to a Genmab release.

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

"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, CEO of Genmab.

The data was presented last week at the 46th American Society of Haematology (ASH) Annual Meeting and Exposition in San Diego, California.

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