Non-Hodgkin's lymphoma - galiximab
Non-Hodgkin's lymphoma is not a single disease but a group of cancers caused by lymphocytes. It can develop in any of the organs associated with the lymphatic system, such as the tonsils, lymph nodes or spleen, and while prognosis for patients with NHL have improved in recent years, relapse and refractory rates remain high.
Non-Hodgkin's lymphoma is not a single disease but a group of cancers caused by lymphocytes. It can develop in any of the organs associated with the lymphatic system, such as the tonsils, lymph nodes or spleen, and while prognosis for patients with NHL have improved in recent years, relapse and refractory rates remain high.
A potential target for anticancer treatment is CD80, a co-stimulatory molecule that plays an important part in regulating T cells, in addition to both normal and malignant B cell activity. CD80 is expressed on both activated B cells and various B cell lymphomas, and galiximab is an anti-CD80 monoclonal antibody being developed by Biogen Idec. It was initially being investigated to treat psoriasis, in which CD80 is also implicated, but it was not sufficiently efficacious in Phase II trials.
It was given to 35 patients with relapsed or refractory follicular lymphoma in a multicentre dose escalating Phase I/II trial.1 Subjects were given four weekly one hour intravenous infusions of 125-500mg/m2 of the drug. An overall response rate of 11% was seen, and of the four responders two had a complete response and one a partial response; three were given 375mg/m2 and the fourth 500mg/m2. Twelve more patients achieved stable disease, and about half of the patients had a decrease in indicator lesions. Median time to progression was 1.7 months, but two patients remained in the trial without their disease progressing for about two years.
Another Phase I/II trial is looking at its efficacy in combination with rituximab in patients with relapsed or refractory follicular lymphoma. All 12 of the patients in the group completed the Phase I part of the trial and reached initial efficacy evaluation on day 50.2 Three of them achieved a complete response or unconfirmed complete response, and a further four a partial response. In the Phase II part of the trial, a total of 64 patients were given 500mg/m2 of galiximab and 375mg/m2 of rituximab once a week for four weeks.3 At follow up a median of 20.4 months later, an overall response rate of 64% was seen, with 17% achieving a complete response, 16% an unconfirmed complete response, and 31% partial responses. Median progression free survival was a year, three month longer than for patients given rituximab alone. Trials of galiximab in combination with rituximab continue.