New Anticancer Agents: Phase II Trial Results

Data on a number of new anticancer agents at varying levels of development were presented at the 19th Congress of the European Society for Medical Oncology held in Lisbon, Portugal last month. The most interesting of the agents in Phase II included:

- a Phase II study of Ares-Serono's thymostimulin treatment in hepatocellular carcinoma with liver cirrhosis. Patients varied between stage I and stage III disease. All patients were treated with thymostimulin at a dose of 70mg/day five times per week. 11 patients achieved an objective response with an overall response rate of 24%. Of these, six patients had a complete response with a median duration of 17 months, five patients achieved a partial response with a median duration of 14 months and 12 patients had stable disease lasting from two to 20 months. 17 patients had disease progression. The therapy was well tolerated and no major side effects were observed; and

- UCB Pharma's rogletimide. In a 26 patient, Phase I/II trial in hormone resistant prostatic cancer patients with metastatic and locally advanced disease, the agent was well tolerated and showed an improvement in symptomatic benefit of 21%. The drug was administered in a dose escalation format at 200, 400, 600 and 800mg/bid during the Phase I part of the study and the highest dose was evaluated in the second half of the trial. The median survival rate was over 10 months and lethargy and tiredness were the most frequent adverse events. The researchers noted that there was one complete remission in the treated group and two partial remissions in the treated group, and recommended that the drug be tested in comparison with other second line agents;