Enobosarm

Published

dm+d

Unassigned

New Medicines

OstarineCancer cachexia; prevention and treatment in pts with NSCLC

Information

Ostarine
New molecular entity
GTXi
GTXi

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Mar 15: No development reported in company pipeline; assume discontinued [11].

Category

selective androgen receptor modulator (SARM) - first in class
Cancer cachexia; prevention and treatment in pts with NSCLC
Oral

Trial or other data

Aug 13: The PIII POWER trials failed to meet the overall criteria for the co-primary responder endpoints of lean body mass and physical function as agreed with the FDA; the responder endpoints showed mixed results (for POWER1 and POWER2, p=0.036 and 0.113 at Day 84 for LBM, respectively; p=0.315 and 0.289 at Day 84 for SCP, respectively). Initial exploratory quantitative analysis demonstrated enobosarm had a consistent effect on LBM relative to placebo in both studies at all assessment times. Corresponding analyses for SCP were inconsistent. Across both trials, enobosarm was generally well tolerated. In POWER1, the four most common AEs were nausea, alopecia, anaemia and vomiting; in POWER2, they were anaemia, nausea, neutropenia and vomiting. In the safety analysis of survival, there was no evidence of a difference between patients treated with enobosarm and placebo in either trial [8].

Evidence based evaluations