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WCLC: Results From ROMANA Trials of Anamorelin in Advanced NSCLC Patients With Cachexia

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Key Points

  • Over 12 weeks, anamorelin significantly increased median lean body mass vs placebo in ROMANA 1 and ROMANA 2.
  • In both studies, there was no difference in handgrip strength changes between treatment arms.
  • Survival improved for patients who maintained or gained lean body mass vs patients who lost lean body mass, regardless of treatment.

Two phase III studies of anamorelin found that the medication effectively combats wasting and increases body weight and lean body mass in certain patients with lung cancer. Results (Abstract ORAL29.01) from the ROMANA 1 and ROMANA 2 phase III trials of anamorelin were presented at the 16th World Conference on Lung Cancer (WCLC) hosted by the International Association of the Study of Lung Cancer (IASLC) in Denver, Colorado.

Anamorelin and Cachexia

Anamorelin is a novel, orally active, selective ghrelin receptor agonist. It mimics ghrelin, the “hunger hormone” that stimulates appetite, and also regulates the 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, 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 Pickar Abernethy, MD, Director of the Duke University Cancer Care Research Program and Professor of Medicine in the Division of Oncology at Duke University School of Medicine. “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 Results

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. Dr. Pickar Abernethy and colleagues found that over 12 weeks, anamorelin significantly increased median lean body mass vs placebo in ROMANA 1 and ROMANA 2. In both studies, there was no difference in handgrip strength changes between treatment arms.

A significantly greater proportion of patients in the anamorelin arm vs the placebo arm maintained/gained lean body mass in both ROMANA 1 and ROMANA 2.

Additionally, survival improved for patients who maintained or gained lean body mass vs patients who lost lean body mass, 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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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