Anamorelin, a once-daily ghrelin receptor agonist, significantly increased lean body mass compared to placebo in two phase III trials in non-small cell lung cancer patients with cachexia.
In both international, double-blind, 12-week studies, ROMANA 1 and ROMANA 2, anamorelin was shown to significantly increase lean body mass and was generally well tolerated; serious drug-related adverse events affected less than 3 percent of patients, mainly relating to hyperglycemia and diabetes.
Anamorelin consistently increased body weight (p<0.0001), and improved patient symptoms and concerns (p=0.0004 and p=0.0016) related to cancer anorexia-cachexia, as secondary endpoints in both studies. Changes in handgrip strength, the second primary endpoint investigated, were not significantly different from placebo in either study.
ROMANA 1 and ROMANA 2 evaluated patients with unresectable Stage III/IV NSCLC with an ECOG performance score of 0-2 and cachexia—greater than or equal to 5 percent weight loss within six months or a body mass index of less than 20 kg/m^2.
Patients were randomized 2:1 to 100 mg anamorelin or placebo, given daily for 12 weeks, and were permitted to receive chemotherapy while on study.
Co-primary endpoints were change from baseline over 12 weeks in lean body mass, measured by Dual-energy X-ray absorptiometry, and in handgrip strength. Secondary endpoints included change in body weight and in the anorexia-cachexia subdomain of the Functional Assessment of Anorexia/Cachexia Therapy questionnaire.
In ROMANA 1, the median change in LBM was 1.10 kg (95% CI 0.76; 1.42) for anamorelin compared with -0.44 kg (95% CI -0.88; 0.20) for placebo. In ROMANA 2, the median change in LBM was 0.75 kg (95% CI 0.51; 1.00) for anamorelin compared with -0.96 kg (95% CI -1.27; -0.46) for placebo.
Anamorelin is sponsored by The Helsinn Group.
