Anamorelin
Two-phase III, double-blind trials (ROMANA 1, NCT01387269, n = 484;
ROMANA 2, NCT01387282, n = 495) evaluated the efficacy and safety of
anamorelin 100 mg in patients with incalculable stage III / IV lung
cancer and cachexia defined as ≥5% weight loss in the last 6 months or
a body mass index <20 kg / m2. In both studies, anamorelin
increased lean body mass compared to placebo (ROMANA 1: 1.10 kg for
anamorelin, -0.44 kg for placebo; ROMANA 2: 0.75 kg for anamorelin, 0.96
kg for placebo; P <0.0001 for both), but did not significantly
improve handgrip strength.56 Subsequently, an extension study, ROMANA3
(NCT01395914), involving 513 patients with ROMANA1 and ROMANA2 NSCLC,
assessed the efficacy and safety of anamorelin for another 12 weeks. As
in previous studies, anamorelin has been associated with a favorable
safety profile and increased body weight, but not muscle strength
[44]. Anamorelin showed similar results in a clinical trial that
included patients with NSCLC-induced cachexia in Japan [Clinical trial
record: JapicCTI-111415 (Japan Pharmaceutical Information Center
Clinical Trials Although several clinical studies have shown that
anamorelin increased muscle mass, but not muscle strength, anamorelin
did not receive approval in 2017, despite promising results in clinical
studies, because increasing muscle mass without a significant increase
in muscle strength was not considered acceptable.
Table 1. Current status of the main GHS found.