- Median weight-loss at baseline was 5%.
- LBM and stair climb power were lower than typically observed in healthy individuals indicating significant functional decline before starting chemotherapy for NSCLC.
- Majority of patients presented with stage IV NSCLC.
- Most patients were ECOG 1.
Improved Physical Function is Associated with Increased Lean Body Mass (LBM): Findings From a Phase 2 Trial of the Selective Androgen Receptor Modulator (SARM) Enobosarm.This poster summarized the associations between changes in lean body mass and physical function in a Phase 2 enobosarm trial. Enobosarm has been evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess its effects on muscle wasting and physical function in patients with cancer. The Phase 2 trial enrolled 159 patients with NSCLC, colorectal cancer (CRC), non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or breast cancer, who had not yet begun chemotherapy or were between chemotherapy cycles. The trial was designed to assess the effects of enobosarm on total LBM (muscle), with secondary objectives including assessments of the effects of enobosarm on total body weight, physical function, and quality of life. Total LBM assessed by DXA and physical function measured by the stair climb test (power) were assessed at baseline and Day 113/end of study. Key findings included:
- Patients with >0.25 kg gain in LBM were more likely to have a substantially meaningful response in physical function (62% versus 34%, p=0.017; Fisher’s Exact Test). These patients also had improvement in percentage change in stair climb power, median +12% versus +0.8% (p=0.017; Wilcoxon Rank Sum Test).
- This finding validates the value of these endpoints in the ongoing Phase 3 trials with enobosarm directed at preventing and treating muscle wasting in patients with cancer.