publication date: Oct. 30, 2014

Anamorelin Increases Body Mass in Two Global Phase III Trials


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, … Continue reading CCL Oct – Cachexia

To access this members-only content, please log in.
Institutional subscribers, please log in with your IP.
If you're not a subscriber why not join today?
To gain access to the members only content click here to subscribe.
You will be given immediate access to premium content on the site.
Click here to join.

Copyright (c) 2020 The Cancer Letter Inc.