publication date: Mar. 31, 2016


Two Phase III Anamorelin Trials Show Improved Lean Body Mass


Two phase III trials in non-small cell lung cancer patients with cachexia found that treatment with anamorelin significantly improved lean body mass and body weight compared to placebo, in addition to improving symptom burden, including appetite. No differences in handgrip strength were observed, one of the co-primary endpoints of the study.

Most participants in the trials were receiving chemotherapy. Improvements in patients’ weight and symptom burden were observed as early as three weeks and progressive, according to Helsinn, which sponsored the studies. The two studies, ROMANA 1 and ROMANA 2, were published in The Lancet Oncology.

The international, double-blind trials evaluated the efficacy and safety of anamorelin in patients with stage III/IV NSCLC and cachexia (greater than or equal to 5 percent weight loss within six months or BMI <20 kg/m[2]).

ROMANA 1 enrolled 484 patients and ROMANA 2 enrolled 495 patients. Patients were randomized 2:1 to 100 mg anamorelin or placebo, given daily orally for 12 weeks, and were permitted to receive chemotherapy while on study.

Efficacy was assessed through change from baseline in the co-primary endpoints, lean body mass (measured by dual-energy X-ray absorptiometry) and handgrip strength, and in the secondary endpoints, which included body weight, and the anorexia-cachexia symptoms and concerns.

Over 12 weeks, anamorelin significantly increased median lean body mass versus placebo in ROMANA 1 (0.99 vs -0.47 kg; p<0.001) and ROMANA 2 (0.65 vs … Continue reading CCL March – Two Phase III Anamorelin Trials Show Improved Lean Body Mass

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