Cancer anorexia-cachexia frequently occurs in NSCLC patients, may be accompanied by systemic inflammation, and results in reduced muscle/lean body mass (LBM) and decreased appetite. The randomized, phase 3, double-blind ROMANA 1 (NCT01387269; N = 484) and ROMANA 2 (NCT01387282; N = 495) trials in cachectic NSCLC patients demonstrated that the ghrelin receptor agonist anamorelin improved LBM, body weight, fat mass (FM), and symptom burden compared with placebo, and was well tolerated. This analysis compared the efficacy of anamorelin in patients with or without an APPR (C-reactive protein [CRP] >10 or ≤10 mg/L, respectively).
Patients with stage III/IV NSCLC and cachexia (≥5% weight loss during prior 6 months or body mass index
An APPR was observed at baseline in approximately 64% of patients enrolled, with similar proportions between the 2 arms and no clear difference in change from baseline in CRP over 12 weeks (anamorelin: 0.5 ± 44.4 mg/L; placebo: –6.8 ± 48.20 mg/L). In anamorelin- vs placebo-treated patients, consistent increases in LBM were seen both in patients with an APPR (1.55 kg [1.02–2.07]; p
Anamorelin does not influence APPR and leads to consistent improvements in LBM, FM and A/CS symptoms of patients regardless of APPR status.
Clinical trial identification
ROMANA 1: NCT01387269; ROMANA 2: NCT01387282
Legal entity responsible for the study
D. Currow: Advisory board (unpaid): Helsinn. Consultant, intellectual property: Mayne Pharma. Consultant: Specialist Therapeutics Australia Pty. Ltd. A. Abernethy: Stock ownership: Athena Health, Inc; Flatiron Health; Orange Leaf Associates. Advisory board: Bristol-Myers Squibb; Helsinn Therapeutics. Board of directors: Athena Health, Inc. Employee of Flatiron Health and leadership of Athena Health, Inc. J. Friend: Employee: Helsinn Therapeutics (US), Inc. Patents, royalties, other intellectual property: Helsinn Therapeutics (US), Inc. R. Giorgino: Employee: Helsinn. Patents, royalties, other intellectual property: Helsinn. K.C. Fearon: Advisory board: Helsinn. Corporate-sponsored research: grants received from Helsinn. Honorarium received from Helsinn. All other authors have declared no conflicts of interest.