Anamorelin Shows Increased Survival in Non-Small Cell Lung Cancer

Researchers discovered that the use of anamorelin among patients with advanced non—small cell lung cancer considerably helped more patients stabilize or gain lean body mass, a factor that consequently enables patients with cachexia to survive longer.

The study results of the ROMANA phase III study were presented at the International Association for the Study of Lung Cancer’s 16th World Conference on Lung Cancer (WCLC) in Denver.¹The data further supported previous findings that demonstrated a positive correlation between the cancer drug and increased lean body mass.

Previous presentations at the ESMO 2014 and ASCO 2015 meetings detailed the ROMANA I and ROMANA II study findings, demonstrating an increase in lean body mass during treatment with anamorelin. Serious drug-related adverse events (AEs) affected less than 3% of the patients involved in the studies.

The findings presented at WCLC further reinforce anamorelin’s positive connection to weight gain in patients with NSCLC. According to the presentation, a greater percentage of patients demonstrated a maintained or increased lean body mass compared with placebo in both studies. When both study results were explored together, overall survival (OS) significantly increased among patients who were able to stabilize or increase their lean body mass.

Researchers asserted that anamorelin’s affect on body weight allows patients who face both NSCLC and cachexia to survive longer. Patients battling cancer often experience symptoms of anorexia, which entails loss of appetite and inevitably decreased body mass. However, treatment options for cachexia and anorexia are very limited.

Greater body mass and especially lean body mass play a critical role in helping cancer patients achieve healthier levels during treatment stages. These findings regarding anamorelin use among patients with NSCLC showed that its treatment can produce a significant impact in patient palliative care.

Anamorelin is an investigational, orally active ghrelin receptor agonist that is targeted to treat symptoms of cachexia, anorexia, and unexpected weight loss in patients with NSCLC. Though the novel drug is not yet approved by any regulatory body, the drug is designed to stimulate multiple pathways to positively regulate body weight, lean body mass, appetite, and metabolism.

In doing so, maintained or increased body weight has the potential to increase a patient’s life expectancy considerably as demonstrated by the findings presented in September at the WCLC.

These latest findings originated from the ROMANA I and ROMANA II studies, which were two international, double-blind, phase III trials that each examined nearly 500 patients. Study participants either received the cancer drug or a placebo orally over a 12-week period, which was determined at a random 2:1 ratio by the study researchers. Patients were able to continue chemotherapy treatment during the trial.

According to the report, researchers were first able to measure co-primary endpoints over the 12-week trial period by change in lean body mass and handgrip strength from baseline. The secondary endpoints consisted of the change in body weight, anorexia symptoms, and 1-year OS of participants in both studies. Additionally, there were few drug-related adverse events, the only most common of which was hyperglycemia among patients.

Reference

Helsinn.com. Additional data for anamorelin in ROMANA 1 and ROMANA 2 studies | Helsinn Corporate. 2015. http://www.helsinn.com/news/additional-data-for-anamorelin-in-romana-1-and-romana-2-studies/. Accessed October 9, 2015.