Results of ROMANA phase III trials of ONO 7643 (anamorelin) in non-small cell lung cancer published in Lancet Oncology- Helsinn

Helsinn has announced that on February 19th, the journal The Lancet Oncology published the results from the pivotal ROMANA Phase III trials assessing efficacy and safety of the ghrelin receptor agonist ONO 7643 (anamorelin) in patients with Cancer Anorexia-Cachexia in non-small cell lung cancer (NSCLC). Over 12 weeks, anamorelin significantly increased median lean body mass versus placebo in ROMANA 1 (0.99 vs -0.47 kg; p<0.001) and ROMANA 2 (0.65 vs -0.98 kg; p<0.0001); in both studies changes in handgrip strength were not different between patients receiving anamorelin or placebo. Anamorelin-treated patients also significantly improved compared to placebo Cancer Anorexia-Cachexia symptoms and concerns (ROMANA 1: 4.12 vs 1.92; and ROMANA 2: 3.48 vs 1.34), and significantly gained body weight (ROMANA 1: 2.20 vs 0.14 kg; and ROMANA 2: 0.95 vs -0.57 kg). Finally, there were no differences in grade 3-4 drug-related adverse events between study arms. Hyperglycemia was the most common grade 3-4 drug-related adverse event occurring in less or equal to 1% of patients receiving anamorelin.

The ROMANA 1 and ROMANA 2 phase III studies clinically demonstrated that anamorelin significantly improved, in respect to placebo, lean body mass and body weight, in addition to symptom burden, including appetite, in NSCLC patients with Cancer Cachexia. No differences between patients treated with anamorelin or placebo were observed for handgrip strength, one of the co-primary endpoint of the study. Improvements in patients' weight and symptom burden were rapid (as early as three weeks) and progressive, which is important in a debilitated population. Most participants in the trials were receiving chemotherapy, indicating that Cancer Anorexia-Cachexia can occur also in patients undergoing active treatment.