Date: 2016-06-01
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Helsinn Group (Switzerland)
Product: anamorelin
Action
mechanism: peptide
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: Belarus, Belgium, Canada, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Russian Federation, Serbia, Slovenia, Spain, Ukraine, USA
Trial
details: ROMANA-1 (NCT01387269 ) ROMANA- 2 (NCT01387282 ) ROMANA-3 (NCT01395914) are evaluating anamorelin HCl in the treatment of non-small cell lung cancer (NSCLC)-cachexia (NSCLC-C).
Latest
news: * On June 1, 2016, Helsinn announced that it will present the results of a pooled efficacy analysis of the pivotal ROMANA Phase III trials in a poster presentation at the American Society of Clinical Oncology (ASCO) meeting on June 6th, in Chicago, U.S.A. The studies assessed the efficacy and safety of the ghrelin receptor agonist anamorelin in patients with Cancer Anorexia-Cachexia and non-small cell lung cancer (NSCLC). It was previously shown that in cachectic NSCLC patients, anamorelin significantly increased the lean and fat mass, and improved concerns related to anorexia-cachexia. The analysis showed in the ASCO paper, “Anamorelin in cachectic patients with non-small cell lung cancer (NSCLC) and low BMI (< 20 kg/m2), a pooled efficacy data analysis of two phase III studies”, assesses the response to anamorelin specifically in malnourished patients with a BMI below 20 kg/m2. This post-hoc pooled analysis of efficacy data from two trials was conducted in patients with BMI < 20 kg/m2 (N=182) and with BMI ? 20 kg/m2 (N=647). Endpoints included changes in lean body mass (LBM), fat mass (FM), HGS, and changes in self-reported anorexia/cachexia concerns and fatigue. Authors of the study were David Currow, Jennifer Temel, Amy Abernethy, Ruben Giorgino, John Friend and Ken Fearon. “This study suggests that malnourished patients with a low BMI respond well to anamorelin, in particular in terms of fatigue. * On February 23, 2016, Helsinn, the Swiss pharmaceutical Group focused on building quality cancer care, announced that on February 19th, The Lancet Oncology, published the results from the pivotal ROMANA Phase III trials assessing efficacy and safety of the ghrelin receptor agonist anamorelin in patients with Cancer Anorexia-Cachexia in non-small cell lung cancer (NSCLC). The lead author was Dr. Jennifer Temel, from the Massachusetts General Hospital in Boston (USA). The paper in The Lancet Oncology is titled “Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results fromtwo randomised, double-blind, phase 3 trials”.
This follow up data bolsters the previous strong data from the landmark Phase III ROMANA 1 and ROMANA 2 studies, showing that anamorelin increases lean body mass, fat and improves patient symptoms related to anorexia and cachexia.”
