ROMANA 3 Adds Extended Use Anamorelin Evidence For NSCLC-Related Cachexia

Extended use of anamorelin continues weight gain and reduction of anorexia–cachexia symptoms in stage III/IV non-small-cell lung cancer patients

medwireNews: Findings from the ROMANA 3 trial suggest that anamorelin continues to be well tolerated and effective for non-small-cell lung cancer (NSCLC) patients with cachexia after more than 12 weeks of treatment.

The study is a safety extension of the previously reported phase III ROMANA 1 and ROMANA 2 trials which indicated that the ghrelin receptor agonist combated lean body mass loss and led to weight gain, compared with placebo, in patients with inoperable stage III or IV disease.

As reported in the Annals of Oncology, 513 participants from ROMANA 1 and ROMANA 2 were recruited to ROMANA 3, including 345 patients who had been assigned to receive anamorelin 100 mg/day for 12 weeks and 168 given placebo.

The patients, all of whom had a preserved ECOG performance status of 2 or lower, were enrolled to continue their treatment for a further 12 weeks, explain David Currow, from the University of Technology Sydney in New South Wales, Australia, and co-authors.

The anamorelin and control groups experienced similar low rates of hyperglycaemia and other treatment-emergent adverse events (52.2 vs 55.7%), grade 3 or worse events (22.4 vs 21.6%) and serious events (12.8 vs 12.6%).

“Thus, anamorelin appears suitable for longer-term cachexia interventions that might also include other modalities (eg, exercise or nutritional support)”, the researchers comment.

Moreover, the team reports that “[i]mprovements in body weight and anorexia–cachexia symptoms observed in the original trials were consistently maintained over 12-24 [weeks].”

Patients using anamorelin had a significantly greater increase in body weight from entry in their original study at all timepoints over the ROMANA 3 trial compared with placebo-treated controls, as well as significant improvements in anorexia–cachexia symptoms at weeks 3, 6, 9, 12 and 16.

As found in the ROMANA 1 and ROMANA 2 trials, however, neither treatment group achieved a significant improvement in their handgrip strength.

“These results are clinically relevant to patients with advanced-stage, metastatic disease, a population that undergoes significant cachexia-related weight loss”, David Currow et al observe.

“In addition to improving the negative symptoms of cancer cachexia, the positive effects on body weight may help ease the emergent psychosocial distress associated with substantial weight loss”, they hypothesize.


Currow D, Temel JS, Abernethy A, et al. ROMANA 3: A phase 3 safety extension study of anamorelin in advanced non-small cell lung cancer (NSCLC) patients with cachexia. Ann Oncol; Advance online publication 4 May 2017. doi:

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