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.