Cellcor's Phase III results with its maintenance autolymphocyte therapy in advanced kidney cancer patients showed no statistical differences between three dosing schedules, according to a presentation at the 9th Annual Scientific Meeting of the Society for Biological Therapy in Napa, California. However, in comparison to historical controls, which have a median survival time of six to 13 months, the median survival of all 150 patients was prolonged to 27 months.
The trial was designed to compare the three different maintenance schedules of ALT in patients who had already completed an initial six-month core ALT regimen. Patients were randomized to receive ALT monthly, quarterly, or delayed for nine months followed by quarterly treatments. An earlier Phase III trial of ALT, also in metastatic kidney cancer, demonstrated that patients who received ALT showed a median survival of 20 months.
The company reported that extended survival was accompanied by complete and partial tumor responses comparable to other immunotherapies. Median duration of partial responses (tumor shrinkage between 50% - <100%) was 11 months and for complete responses it was 24 months with some complete responses ongoing at more than 36 months. In addition, reported Cellcor, there were no signs of any significant toxicity associated with the treatment.
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