InterMune Inc. has decided 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. This decision was based on the results of an interim analysis conducted by an independent Data Safety Monitoring Board (DSMB).
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, defined as International Federation of Gynaecology and Obstetrics (FIGO) stage III or IV. The primary endpoint was overall survival. The last patient completed dosing in mid-2004 and patients are currently in post-treatment follow-up, states the company release.
After reviewing the results of an analysis of Progression Free Survival (PFS) time and an interim analysis of Overall Survival (OS) time, the DSMB 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 (39.7%) patients in the Actimmune group died as compared to 128 out of 421 (30.4%) patients who received chemotherapy alone. There was no difference in PFS time between treatment groups.
"We are disappointed that Actimmune in combination with carboplatin and paclitaxel did not benefit patients with ovarian cancer. The results from this study suggest that Actimmune, which has generally been well-tolerated in studies across multiple disease states, may exacerbate the dose-limiting toxicities of cytotoxic chemotherapy drugs. Consequently, we have no plans to initiate further studies of Actimmune in oncology or in combination with such chemotherapy regimens," said Steven Porter, chief medical officer of InterMune.
Actimmune is a synthesised version of interferon gamma, a naturally occurring protein believed to stimulate the immune system.
InterMune is a biotechnology company focused on the research, development and commercialisation of innovative therapies in pulmonology and hepatology.