Lugano, Switzerland, 09 September, 2015: Helsinn, a Swiss Group focused on building quality cancer care, announced today that additional study results from the ROMANA Phase III program were presented at the International Association for the Study of Lung Cancer’s 16th World Conference on Lung Cancer (WCLC), taking place in Denver from 06 September to 09 September, 2015.
An oral presentation took place during the Palliative and Supportive Care Session on 08 September, 2015 entitled “Results from the ROMANA Phase III Studies of Anamorelin in Advanced Non-Small Cell Lung Cancer Patients with Cachexia” (Abstract 1359), focusing on lean body mass responder analyses.
Previous presentations at ESMO 2014 and ASCO 2015 annual meetings showed that anamorelin significantly increased lean body mass (p<0.0001) compared with placebo in both 12-week studies, and was generally well tolerated; serious drug-related adverse events affected less than 3% of patients, mainly relating to hyperglycemia and diabetes.
The additional data presented at this meeting showed that a significantly higher proportion of patients treated with anamorelin maintained or gained lean body mass in both studies compared to placebo (ROMANA 1: 58.1% vs 36.9%; p<0.001; ROMANA 2: 51.5% vs 26.5%; p<0.001). In an exploratory analysis of overall survival combining both studies, patients who were able to stabilize or increase lean body mass had a significant improvement in overall survival (p<0.001) versus patients who lost lean body mass, regardless of treatment, showing that maintaining or improving lean body mass enables advanced NSCLC patients with cachexia to survive longer.
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 advanced Stage III/IV NSCLC and cachexia (≥5% weight loss within six months or BMI <20 kg/m2). ROMANA 1 enrolled 484 patients and ROMANA 2 enrolled 495 patients. Patients were randomized (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 changed from baseline over 12 weeks in lean body mass (LBM) (measured by dual-energy X-ray absorptiometry) and in handgrip strength. Secondary endpoints included change in body weight and in the anorexia-symptoms and concerns, as well as 1-year overall survival for the two studies combined. A pre-specified exploratory endpoint summarized the incidence of patients who maintained/gained LBM from baseline during 12 weeks by treatment group. Post-hoc exploratory analysis compared overall survival data in patients who decreased LBM during 12 weeks versus those who maintained/gained LBM regardless of treatment arm. Safety assessments included lab values and adverse events.
Over 12 weeks, anamorelin significantly increased median LBM versus placebo in ROMANA 1 (1.10 vs -0.44 kg; p<0.001) and ROMANA 2 (0.75 vs -0.96 kg; p<0.001); in both studies there was no difference in HGS changes between treatment arms. A significantly greater proportion of patients in the anamorelin arm versus the placebo arm maintained/gained LBM in both ROMANA 1 (58.1% vs 36.9%; p<0.001) and ROMANA 2 (51.5% vs 26.5%; p<0.001). Post-hoc analysis showed that overall survival was improved for patients who maintained/gained LBM versus patients who lost LBM (HR, 0.53 [95% CI, 0.42, 0.68]; p<0.001). Anamorelin-treated patients also significantly gained body weight (2.20 vs 0.14 kg; p<0.001) and (0.95 vs ‑0.57 kg; p<0.001), and significantly improved anorexia-cachexia symptoms and concerns (4.12 vs 1.92; <0.001) and (3.48 vs 1.34; p=0.002), compared with placebo-treated patients, in ROMANA 1 and 2, respectively. The most frequent drug-related adverse event (AE) in the anamorelin arm in both ROMANA 1 and 2 was hyperglycemia (5.3% and 4.2%); there were few drug-related grade ≥3 AEs in the anamorelin arm versus the placebo arm (0.9% vs 1.2% and 2.7% vs 2.5%).
Notes for editors:
About cancer anorexia and cachexia
Cachexia is characterized by decreased body weight, mainly lean body mass (LBM), and is often accompanied by anorexia (loss of appetite). Loss of body weight/LBM and appetite commonly occurs in advanced cancer patients, although the pathophysiology is poorly understood. Despite high prevalence and debilitating effects on cancer patients, existing treatment approaches for cachexia and anorexia in cancer patients are limited.
Non-small cell lung cancer accounts for roughly 85% of all lung cancer cases. Lung cancer has some of the poorest survival rates comparing to other types of cancer, based on epidemiological data, and is the most common form of cancer globally.
About anamorelin and ghrelin
Anamorelin is an investigational agent that has not yet been approved by any regulatory authority.
Anamorelin HCl is an investigational selective, novel, orally active ghrelin receptor agonist that is under development for the treatment of Anorexia, Cachexia, and Unintended Weight Loss in NSCLC patients. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, lean body mass, appetite and metabolism.
The information discussed in this release is not intended to convey conclusions about its efficacy and safety.
About the Helsinn Group
Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.
Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of productand scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn’s products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com.
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