These findings were presented at the 2014 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, September 26–30.
Cancer cachexia is a “wasting” condition in which the patient progressively loses significant amounts of bodyweight and muscle mass and suffers from weakness. Effective treatment for cachexia has been sorely needed, as it affects quality of life and can interfere with a patient’s treatment plan.
The drug anamorelin is designed to stimulate hunger by creating the same effects in the body as the so-called “hunger hormone” ghrelin, which helps regulate appetite. By simulating a ghrelin-like response in the body, anamorelin may increase appetite in patients and may also help the body build more lean body mass.
To test anamorelin as treatment for cancer cachexia, researchers conducted two international Phase III trials in patients with Stage III and IV non–small cell lung cancer (NSCLC). Combined, the studies included a total of 979 patients. These patients had been diagnosed with cachexia based on weight loss of 5% or greater within the previous six months or a below-normal body mass index. Participants were assigned to receive either 100 mg of anamorelin or a placebo; both were given orally on a daily basis for 12 weeks. All patients were allowed to receive chemotherapy during the study.
During the 12 weeks of treatment, patients had their lean body mass measured as well as strength (which was measured by handgrip strength). Researchers also measured patient body weight and monitored for side effects.
In one trial patients who received anamorelin gained significantly more lean body mass than those who received placebo: the anamorelin group gained a median of almost 2.5 pounds, while the placebo group lost a median of just under 1 pound. Results were similar in the other trial: patients on anamorelin gained a media of more than 1.5 pounds, while those on placebo gained a median of about 2 pounds. Patients on anamorelin in both studies also gained more overall body weight than those on placebo, with gains from just under 1 pound to almost 5 pounds. There were no significant changes in handgrip strength between treatment groups. In both studies combined, side effects included hyperglycemia (high blood sugar), nausea, and diabetes; severe side effects were rare.
With findings from two global studies showing that anamorelin can help patients with advanced NSCLC gain weight, the drug appears to be promising treatment for cancer cachexia. In addition, 12 weeks of treatment with anamorelin was well tolerated in both studies.
According to Associate Professor Florian Strasser from Cantonal Hospital St.Gallen, Switzerland, Chair of the ESMO Palliative Care Working Group, anamorelin is the first drug to effectively treat cancer cachexia in this level of study. He added that further study is aimed at confirming the effectiveness of anemorelin for treatment of cachexia. “This would be a novel finding: a drug stimulating appetite resulting in more muscle mass and increasing reserves,” Dr. Strasser said.
 Temel J, Fearon K, Yan Y, et al. 1483O_PR – Anamorelin for the Treatment of Cancer anorexia-Cachexia in NSCLC: Results from the Phase 3 Studies ROMANA 1 and 2. European Society for Medical Oncology (ESMO) Congress 2014: Abstract 1483O_PR. Presented September 27, 2014.
 ESMO 2014 Press Release: Anamorelin Shown to Improve Appetite and Body Mass in Patients with Cancer Anorexia-Cachexia [press release]. The European Society for Medical Oncology website. Available at: http://www.esmo.org/Conferences/ESMO-2014-Congress/Press-Media/Anamorelin-Shown-to-Improve-Appetite-and-Body-Mass-in-Patients-with-Cancer-Anorexia-Cachexia. Accessed October 4, 2014.
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