Genmab announces data on all evaluable patients in HuMax-CD20 NHL Phase I/II study
Genmab A/S announced 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.
Other news from the department research and development
