nterMune Inc has announced that it has discontinued the Phase 3 INSPIRE clinical trial evaluating Actimmune® (interferon gamma-1β) 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.
"The interim results of the INSPIRE trial and our decision to discontinue the trial are disappointing," said Steve Porter, MD, PhD, chief medical officer at InterMune. "We are extremely grateful for the strong support we received from physicians, health care providers and especially the patients who participated in the clinical evaluation of Actimmune. The overall conduct of the study by investigators and the participation by patients were exemplary."
Dan Welch, President and chief executive officer of InterMune, said, “Although we are disappointed by this result with Actimmune, we remain committed to addressing the significant unmet medical need in IPF with pirfenidone through our Phase 3 CAPACITY program.
