ARTICLE | Clinical News

Anamorelin: Phase III data

October 13, 2014 7:00 AM UTC

The double-blind, international Phase III ROMANA 1 trial in 477 non-small cell lung cancer (NSCLC) patients with cachexia showed that once-daily 100 mg anamorelin met the co-primary endpoint of increasing median lean body mass from baseline to week 12 vs. placebo (increase of 1.1 kg vs. a reduction of 0.44 kg, p<0.0001). Anamorelin missed the co-primary endpoint of improving handgrip strength vs. placebo. Anamorelin met the secondary endpoints of improving body weight (2.2 vs. 0.14 kg, p<0.001) and FAACT anorexia-cachexia subdomain score (4.12 vs. 1.92 points, p=0.0004) vs. placebo. Anamorelin was generally well tolerated. Serious treatment-related adverse events reported were mainly related to hyperglycemia and diabetes. Helsinn also reported data from the identical Phase III ROMANA 2 trial. Patients in both trials have the option to continue treatment in the 12-week ROMANA 3 extension trial. Helsinn could not be reached for next steps. ...