A new drug, anamorelin, improves appetite and body mass in patients with advanced lung cancer who are experiencing cancer anorexia and cachexia (CACS). This phase III data was presented at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.

“Anorexia and cachexia are among the most troubling and distressing symptoms of advanced cancer, for both patients and their families,” said the study’s principal investigator, Jennifer Temel, MD, from the Department of Medicine, Massachusetts General Hospital, Boston.

Symptoms of the wasting syndrome can include a loss of weight and muscles, together with fatigue, weakness, and loss of appetite. The condition is very common in patients with advanced lung cancer. Anamorelin aims to address the symptoms by mimicking the effects of ghrelin, also called the hunger hormone, which is secreted by the stomach.

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The large, randomized controlled ROMANA 1 and 2 trials are the first phase III studies examining the impact of anamorelin on anorexia-cachexia in patients with advanced lung cancer. In the ROMANA studies, patients with unresectable stage III or IV non-small cell lung cancer with cachexia were randomized to receive either 100 mg anamorelin or placebo, given orally each day for 12 weeks.

Among 484 participants in ROMANA 1, those taking anamorelin experienced a median increase in lean body mass of 1.10 kg in 12 weeks, compared to a loss of 0.44 kg for those taking placebo. Body weight increased in the anamorelin arm by an average of 2.2 kg, compared to 0.14 kg in the placebo arm of the study. Patient symptoms or concerns regarding anorexia-cachexia, including appetite, also significantly improved over 12 weeks in patients taking anamorelin. The most frequent drug-related adverse events included hyperglycemia and nausea.

In ROMANA 2, 495 participants with advanced non-small cell lung cancer experienced similar benefits. Body weight increased by 0.95 kg on average, compared to a loss of 0.57 kg for those receiving placebo, and patient symptoms/concerns regarding anorexia-cachexia significantly improved over 12 weeks.

Patients receiving anamorelin did not experience improvements in their muscle strength, as measured by hand grip strength, although Temel noted that particular test can be difficult to administer in this patient population.

“Having a safe and well tolerated drug in our armamentarium to improve the incredibly troubling symptoms of anorexia and cachexia will have a dramatic impact on both patients and their families,” summarized Temel.

Commenting on the results, Associate Professor Florian Strasser, MD, from Cantonal Hospital St.Gallen, Switzerland, Chair of the ESMO Palliative Care Working Group, said the results of the Romana trials are promising. “These studies are paving the way towards a multicomponent and most likely also a multimodal treatment for patients suffering from Cancer Anorexia-Cachexia Syndrome.”

“Do these trials already show a true clinical benefit, the clinical effectiveness, in a real world population? Probably not yet. The data are promising since the outcomes reported cover more than one relevant component of the CACS and are related to each other. Anamorelin responds to a yet unmet frequent clinical need having an impact on both the patient and the tumour control outcomes with minimal risk,” Strasser said.