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Genmab reports "rapid responses" in chronic lymphocytic leukemia patients taking HuMax-CD20
New York, Dec. 12 - Genmab A/S said a continuing phase 1/2 study found "rapid responses" in patients with relapsed chronic lymphocytic leukemia taking HuMax-CD20.
By week four, 67% of evaluable patients treated at the highest dose level (2,000 mg) responded to treatment, the Copenhagen, Denmark, biotechnology company said.
Twelve of 26 patients (46%) obtained objective responses lasting at least eight weeks by the NCI working group guidelines for chronic lymphocytic leukemia, including 2 nodular partial remissions.
The patients among the 67% responding included 16 who had responses identified by physical examination and peripheral blood evaluation. Ten patients showed complete responses by absence of enlarged lymph nodes, spleen and liver, and by normalization of blood counts at any time point during the 19 week follow up period. By the National Cancer Institute working group guidelines for chronic lymphocytic leukemia, complete response must be confirmed with CT scan and bone marrow samples. Under the protocol, these were not scheduled to occur until week 19 at the minimum and could take place up to week 26, which could be over five months since the response was initially observed.
The median time to progression in the 12 responding patients has not yet been reached, but will exceed 19 weeks. The time to response is very short with 16 of 26 patients obtaining a clinical complete or partial response at week four.
HuMax-CD20 received fast track designation from the Food and Drug Administration in December 2004 for Genmab's chronic lymphocytic leukemia development program.
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