ONO 7643 offers improvements in Phase III Cachexia trials - Helsinn

Helsinn has announced that ONO 7643 (anamorelin) significantly increased lean body mass (LBM) compared with placebo in two Phase III trials comprising the largest trial program of its kind to date in Non-Small Cell Lung Cancer (NSCLC) patients with Cachexia, an area of significant unmet medical need. In both pivotal 12-week studies, ROMANA 1 and ROMANA 2, anamorelin was shown to significantly increase lean body mass compared with placebo. In ROMANA 1, the median change in LBM was 1.10 kg for anamorelin compared with -0.44 kg for placebo. In ROMANA 2, the median change in LBM was 0.75 kg for anamorelin compared with -0.96 kg for placebo.

It was generally well tolerated; serious drug-related adverse events affected less than 3% of patients, mainly relating to hyperglycemia and diabetes. Compared with placebo, anamorelin consistently increased body weight, and improved patient symptoms and concerns related to Cancer Anorexia-Cachexia, as secondary endpoints in both studies. Changes in hand-grip strength, the second primary endpoint investigated, were not significantly different from placebo in either the ROMANA 1 or ROMANA 2 studies.