Phase III results for enobosam effect on muscle wasting in NSCLC

GTx, Inc. has announced results of its two Phase III enobosarm clinical trials, the POWER trials, in patients with Non-Small Cell Lung Cancer (NSCLC) receiving chemotherapy.

The Company announced that the clinical trials failed to meet the overall criteria for the co-primary responder endpoints of lean body mass (LBM) and physical function as agreed upon with the FDA; the responder endpoints showed mixed results (for POWER1 and POWER2, p values at Day 84 for LBM were 0.036 and 0.113, respectively; p values at Day 84 for stair climb power (SCP) were 0.315 and 0.289, respectively). Initial exploratory quantitative (continuous variable) analysis demonstrated that enobosarm had a consistent effect on LBM relative to placebo in both studies at all assessment times (p values were 0.0003 and 0.0227 at Day 84 for POWER1 and POWER2, respectively). Corresponding analyses for SCP were inconsistent between trials (p values were 0.0336 and 0.7923, respectively). Missing data were well balanced between the arms in both trials for both endpoints. Across both clinical trials, enobosarm was generally well tolerated, with the occurrence of serious adverse events and overall incidence of adverse events similar across placebo and treatment groups.