This news release caught my attention because when I was first diagnosed with idiopathic pulmonary fibrosis (IPF) my physicians tried to get me enrolled in a trial of Actimmune (interferon gamma-1b) but enrollment was already closed. At the time it offered a glimmer of hope for slowing the progression of IPF and extending survival time. But now, sadly, it seems that Actimmune did no better than a placebo in the trials.
BRISBANE, Calif., March 5, 2007 InterMune, Inc. today announced that it has discontinued the Phase 3 INSPIRE clinical trial evaluating Actimmune® (interferon gamma-1b) in patients with idiopathic pulmonary fibrosis (IPF) based upon the recommendation of the study's independent data monitoring committee (DMC). In a planned interim analysis that included a total of 115 deaths, the DMC found the overall survival result crossed a predefined stopping boundary for lack of benefit of Actimmune® relative to placebo. Among the 826 randomized patients, there was not a statistically significant difference between treatment groups in overall mortality (14.5% in the Actimmune group as compared to 12.7% in the placebo group). Based on a preliminary review of the interim safety data, the adverse events associated with Actimmune® therapy appear generally consistent with prior clinical experience, including constitutional symptoms, neutropenia and possibly pneumonia.
INSPIRE was a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Actimmune® in IPF patients with mild to moderate impairment in lung function. The primary endpoint was survival time. The lack of benefit stopping boundary was developed to allow for early study termination in the event interim data were statistically inconsistent with a clinically meaningful treatment effect of Actimmune®. InterMune plans to submit the data from the Phase 3 INSPIRE trial for presentation at an appropriate medical meeting and for publication in a peer-reviewed journal.
Read the full Press Release.