Genmab announced positive interim results in its two Phase II studies with Humax-CD4 to treat cutaneous T-cell lymphoma (CTCL) that involved 11 early stage and 13 advanced stage patients. All 24 patients could be evaluated using the Physician's Global Assessment (PGA).
This assessment showed 55per cent of the early stage and 38per cent of the advanced stage patients achieved at least a partial response (more than 50per cent improvement in their disease). One early stage patient's CTCL was completely cleared. In addition, 9per cent of the early stage and 23per cent of the advanced stage patients achieved a minor response (25-50per cent improvement). The PGA is a comparison to the patient's baseline condition by grading all cancerous lesions from 0 to 6.
In addition, in other measures of the disease state, pruritus (severe and sometimes debilitating itching) was improved in 82per cent of early stage patients and 69per cent of advanced stage patients. Pruritus is most likely the single major parameter for reducing quality of life in CTCL patients.
As previously announced, Genmab is adding patients to the Phase II studies at higher dose levels. The dose level has been increased from the original 280mg per week for 16 weeks in the ongoing studies because CD4+ T-cells were not fully depleted in the initial patients. The objective of using higher doses is to improve responses by further reducing the number of CD4+ T-cells and, thus, the number of cancer cells. At present, 10 early stage patients are being treated with 560mg per week and 7 advanced stage patients are being treated at the 980mg weekly dose level. This brings the total patients in the two studies to 41.
A review of the safety data has indicated that Humax-CD4 appears to have been safe and well tolerated in clinical trials to date. During the Phase II CTCL studies no grade 4 adverse events have occurred. There have been only four grade 3 adverse events and only one of those, skin hypersensitivity, was judged to be possibly treatment related. In addition to CTCL, approximately half of the non-cutaneous T-cell lymphomas express the CD4 receptor on their cell surface and Genmab has also treated a non-cutaneous T-cell lymphoma patient on a compassionate use basis with a good clinical effect.
Considering this and the encouraging data from the CTCL study, Genmab is now making plans to initiate a study in non-cutaneous T-cell lymphoma patients in the second half of 2004, especially since these patients also have a dramatic need for new and less toxic therapies.
"These results are very encouraging," said Lisa N Drakeman, PhD, CEO of Genmab. "It is always good news when you can see a benefit to cancer patients, especially when the medical need is great." These data were presented today at the 45th annual meeting of the American Society of Hematology in San Diego, California.