INTERMUNE HALTS OVARIAN CANCER TRIAL
InterMune has announced the decision to discontinue its GRACES Phase III clinical trial evaluating the safety and efficacy of Actimmune (interferon gamma-1b) in combination with standard of care chemotherapy in patients with advanced ovarian cancer.
GRACES was a Phase III trial comparing carboplatin plus paclitaxel (standard of care chemotherapy) combined with Actimmune to carboplatin plus paclitaxel alone, in the treatment of advanced ovarian cancer. The primary endpoint was overall survival. The last patient completed dosing in mid-2004 and patients are currently in post-treatment follow-up.
After reviewing the results of an analysis of progression-free survival time and an interim analysis of overall survival time, a data safety monitoring board recommended the termination of the ongoing post-treatment follow-up of patients in the study. This recommendation was based on a shorter overall survival time in patients who received Actimmune plus carboplatin and paclitaxel compared to carboplatin and paclitaxel alone. One hundred and sixty-nine out of 426 patients in the Actimmune group died, as compared to 128 out of 421 patients who received chemotherapy alone. There was no difference in PFS time between treatment groups.