Research & Education

Results From Phase III Trials of Anamorelin in Advanced Non-Small Cell Lung Cancer Patients with Cachexia: ROMANA 1 and 2

September 7, 2015

WCLC 2015

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Becky Bunn
IASLC Projects Specialist | 720-325-2946


Results From Phase III Trials of Anamorelin in Advanced Non-Small Cell Lung Cancer Patients with Cachexia: ROMANA 1 and 2

DENVER, Colo. — Two Phase III studies with anamorelin found that the medication effectively combats wasting and increases body weight and lean body mass in certain lung cancer patients.

Results from the ROMANA 1 and ROMANA 2 Phase III trial of anamorelin were presented today in Denver, Colo. at the 16th World Conference on Lung Cancer (WCLC) hosted by the International Association of the Study of Lung Cancer (IASLC).

Anamorelin is a novel, orally active, selective ghrelin receptor agonist. It mimics ghrelin, the “hunger hormone” that stimulates appetite, and also regulates rate of energy usage and pathways involved in body weight and body composition. Cachexia is a debilitating condition often observed in patients with cancer including advanced non-small cell lung cancer (NSCLC). A decrease in body weight, in particular loss of lean body mass (LBM), is a primary characteristic, and is associated with worsening functional status, quality of life, and survival. Despite the high prevalence and substantial clinical impact of cachexia in patients with advanced cancer, limited therapeutic options exist.

“Loss of body weight and muscle mass have consistently been shown to be predictors of poor outcomes and shortened survival. To date, we have lacked effective therapies,” said Amy Abernethy from Durham University, Durham, N.C. and lead researcher on the project. “Now we have two randomized controlled trials that consistently demonstrate the positive impact of anamorelin in improving lean body mass and anorexia symptoms for people with advanced NSCLC and cachexia.”

ROMANA 1 and 2 are two randomized, double-blind, Phase III trials evaluating the efficacy and safety of anamorelin in patients with advanced NSCLC and cachexia. Abernethy and colleagues found that over 12 weeks, anamorelin significantly increased median LBM versus placebo in ROMANA 1 and ROMANA 2. In both studies there was no difference in hand grip strength changes between treatment arms.

A significantly greater proportion of patients in the anamorelin arm versus the placebo arm maintained/gained LBM in both ROMANA 1 and ROMANA 2.

Additionally, survival improved for patients who maintained or gained LBM versus patients who lost LBM, regardless of treatment.

Anamorelin-treated patients also gained significantly more body weight and had significantly improved anorexia-cachexia symptoms compared with placebo-treated patients in both ROMANA 1 and 2 studies.


About the WCLC:

The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting more than 7,000 researchers, physicians and specialists from more than 100 countries. The conference goal is to increase awareness and collaboration so that the latest developments in lung cancer can be understood and implemented throughout the world. Falling under the theme of “Fighting Lung Cancer,” the conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For the first time, IASLC has invited survivors to attend the conference free of charge. For more information on the 2015 WCLC, visit:

About the IASLC:

The International Association for the Study of Lung Cancer (IASLC) is the only global organization specifically dedicated to the study of lung cancer. Founded in 1974, the association's membership includes nearly 4,000 lung cancer specialists in 80 countries. For more information, visit: