This site is intended for health professionals only

Published on 29 September 2014

Share this story:
Twitter
LinkedIn

Pivotal Phase III Trial Data for Anamorelin in ROMANA 1 and 2 Studies

The Helsinn Group, a Company focused on building quality cancer care, announces that anamorelin, its novel, once-daily ghrelin receptor agonist 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.

The Helsinn Group, a Company focused on building quality cancer care, announces that anamorelin, its novel, once-daily ghrelin receptor agonist 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 (p<0.0001) compared with placebo, and 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 (p<0.0001), and improved patient symptoms and concerns (p=0.0004 and p=0.0016) 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.

Jennifer Temel, MD, Clinical Director of Thoracic Oncology at Massachusetts General Hospital Cancer Center and a Principal Investigator in the ROMANA 1 and ROMANA 2 trials, commented: “These data show that anamorelin represents a new option in the treatment of anorexia-cachexia syndrome in patients with advanced non-small cell lung cancer in which patients frequently experience poor QOL due to symptoms such as cachexia, loss of appetite and fatigue. The ROMANA data clearly demonstrates that anamorelin increased lean body mass and improved symptoms related to anorexia and cachexia.”

Riccardo Braglia, Helsinn Group CEO said: “Anamorelin may significantly alleviate some of the most significant symptoms of Cancer Anorexia-Cachexia for patients with non-small cell lung cancer, among the most important factors in preserving the best possible quality of life for patients with this disease.”
Anamorelin offers the potential for a new approach to treating the symptoms of this multifactorial clinical condition, which can be devastating for patients and caregivers, for whom getting the most out of every day is crucial.”

Methodology
ROMANA 1 and ROMANA 2 were two international, 12-week, double-blind, Phase III trials evaluating the efficacy and safety of anamorelin in patients with un-resectable Stage III/IV NSCLC with an ECOG performance score (measuring the performance and health of patients) of 0-2 and cachexia (≥5% weight loss within six months or BMI <20 kg/m2). Patients were randomised (2:1) to 100 mg anamorelin or placebo, given daily orally for 12 weeks and were permitted to receive chemotherapy while on study. Co-primary endpoints were change from baseline over 12 weeks in lean body mass (measured by Dual-energy X- ray absorptiometry) and in handgrip strength. Secondary endpoints included change in body weight and in the anorexia-cachexia subdomain of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire). Safety assessments included lab values and adverse events.

Results
Over 12 weeks, anamorelin significantly increased LBM compared with placebo (p<0.0001) in both studies. In ROMANA 1, the median change in LBM was 1.10 kg [95% CI 0.76; 1.42] for anamorelin compared with -0.44 kg [95% CI -0.88; 0.20] for placebo. In ROMANA 2, the median change in LBM was 0.75 kg (95% CI 0.51; 1.00) for anamorelin compared with -0.96 kg (95% CI -1.27; -0.46) for placebo. Change in hand-grip strength was not statistically different between study arms. Anamorelin (vs placebo) increased body weight (2.20±0.3 vs 0.14±0.4 kg; p<0.0001; and 0.95±0.4 vs -0.57±0.4 kg; p<0.0001) and improved Functional Assessment of Anorexia-Cachexia Treatment (FAACT) sub-domain scores (4.12±0.8 vs 1.92±0.8; p=0.0004; and 3.48±0.9 vs 1.34±1.0; p=0.0016).



Most read




Latest Issue

Be in the know
Subscribe to Hospital Pharmacy Europe newsletter and magazine
Share this story:
Twitter
LinkedIn