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Anamorelin Shows Promise in Lung Cancer Patients With Cachexia

Ghrelin receptor agonist improves lean body mass in pivotal trial

Anamorelin (Helsinn Group), an investigational once-daily ghrelin receptor agonist for the treatment of cancer anorexia–cachexia syndrome (CACS), provided significant improvements in lean body mass (LBM) in a 12-week phase III study in patients with non–small-cell lung cancer (NSCLC).

In the pivotal ROMANA 1 trial, patients treated with anamorelin demonstrated an increase in body weight along with improvements in symptoms and concerns, such as appetite, early satiety, and fatigue.

The ROMANA 1 study was one of two international, double-blind, phase III trials that evaluated the efficacy and safety of anamorelin in patients with NSCLC. Subjects with unresectable stage III/IV NSCLC; an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2; and cachexia (i.e., weight loss of 5% or greater within 6 months or a body mass index [BMI] of less than 20 kg/m) were randomly assigned to receive anamorelin 100 mg or placebo once daily for 12 weeks. The patients were also allowed to receive chemotherapy during the course of the trial.

The study’s co-primary endpoints were the change from baseline over 12 weeks in LBM and in handgrip strength. Secondary endpoints included the change in body weight and quality-of-life outcomes, as assessed by the FAACT (Functional Assessment of Anorexia/Cachexia Therapy) and FACIT-F (Functional Assessment of Chronic Illness Therapy–Fatigue) questionnaires. Safety assessments included laboratory values and adverse events.

Anamorelin significantly increased LBM compared with placebo (median change from baseline: +1.10 kg vs. –0.44 kg, respectively; P < 0.0001). Body weight also increased with anamorelin compared with placebo (+2.20 vs. +0.14 kg, respectively; P < 0.0001).

Differences between treatment groups related to handgrip strength were not statistically significant.

Over the 12-week treatment period, FAACT scores were significantly higher in the anamorelin arm than in the placebo arm (change from baseline: +4.12 vs. +1.92, respectively; P = 0.0004).

For fatigue, FACIT-F scores deteriorated progressively in the placebo arm during the course of the study but remained stable in the anamorelin arm. The difference between treatment groups was significant at the end of the treatment period. Changes from baseline in FACIT-F scores at week 9 were +0.33 for anamorelin and –1.50 for placebo (P = 0.0331). At week 12, the respective scores were +0.48 and –2.10 (P = 0.0244).

The most common drug-related adverse events in the anamorelin group included hyperglycemia and nausea, which affected 5.3% and 3.8% of treated patients, respectively.

Anamorelin is an investigational selective ghrelin receptor agonist. Ghrelin is an endogenous peptide secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, lean body mass, appetite, and metabolism.

Source: PR Newswire; October 30, 2014.

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