Anamorelin (ONO-7643) in Japanese patients with non-small cell lung cancer and cachexia: results of a randomized phase 2 trial

Abstract

PurposeCancer cachexia is characterized by decreased body weight (mainly lean body mass [LBM]) and negatively impacts quality of life (QOL) and prognosis. Anamorelin (ONO-7643) is a novel selective ghrelin receptor agonist under development for treating cancer cachexia.MethodsIn this double-blind, exploratory phase 2 trial, we examined the efficacy and safety of anamorelin in Japanese patients (n = 181) with non-small cell lung cancer (NSCLC) and cancer cachexia (≥5 % weight loss within the previous 6 months). The participants were randomized into three groups and were administered 50 or 100 mg anamorelin, or placebo, orally every day for 12 weeks. The co-primary endpoints were the changes from baseline over 12 weeks in LBM and handgrip strength (HGS). Secondary endpoints included body weight, QOL, Karnofsky Performance Scale (KPS), and serum biomarkers.ResultsThe change in LBM over 12 weeks was 0.55 and 1.15 kg in the placebo and 100-mg anamorelin groups, respectively, but the efficacy of anamorelin in HGS was not detected. The changes in body weight were −0.93, 0.54, and 1.77 kg in the placebo, 50-mg anamorelin, and 100-mg anamorelin groups, respectively. Anamorelin (100 mg) significantly improved KPS and QOL-ACD compared with placebo. Administration of anamorelin for 12 weeks was well tolerated.ConclusionsThis phase 2 study showed that 100 mg anamorelin has promising results in improving lean body mass, performance status, and especially, QOL in patients with cancer cachexia.Electronic supplementary materialThe online version of this article (doi:10.1007/s00520-016-3144-z) contains supplementary material, which is available to authorized users.

Modified glasgow prognostic score in patients with small-cell lung cancer

“…The majority of patients with lung cancer are aged and have comorbid wasting diseases such as chronic obstructive pulmonary disease and chronic heart disease; therefore, they potentially have a high risk of developing cachexia. For patients with NSCLC, the clinical usefulness of anamorelin, an anti-cachexia drug in global phase III and domestic phase II studies in Japan have recently been reported (15,16). For patients with SCLC, early intervention such as prescription of anti-cachexia and nutritional support may improve prognosis.…”

“…The present study was approved by the institutional review committee of Mito Medical Center, University of Tsukuba (Mito, Japan) (no. [16][17][18][19][20] Serum albumin and CRP were those measured at the time of the diagnosis of SCLC. The mGPS was calculated according to the method by Forrest et al (9): Patients with a normal albumin level (3.5 g/dl) and CRP (1.0 mg/dl) were allocated a score of 0, those with both low albumin (<3.5 g/dl) and high CRP (>1.0 mg/dl) were scored 2.…”

Cancer cachexia: Are we ready to take a step forward?

“…These clinical outcomes were studied in a national prospective registry of patients with advanced non–small cell lung cancer (NSCLC) and cachexia in Japan . A loss of weight was associated with worsening quality of life and declines in performance status, biochemical parameters, and handgrip strength.…”

Capromorelin: a ghrelin receptor agonist and novel therapy for stimulation of appetite in dogs

“…Lean body mass and total body weight increased in the anamorelin groups compared to the placebo group (Takayama et al . ). Subsequently anamorelin (100 mg/day for 12 weeks) was tested in two randomized, double‐blind Phase III trials in lung cancer patients with cachexia; over 900 patients were enrolled.…”