Date: 2014-10-30
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology
Company: Helsinn (Switzerland)
Product: anamorelin
Action
mechanism: Anamorelin HCl is an orally administered ghrelin receptor agonist and has been previously studied in approximately 500 subjects, including four completed Phase II trials involving 361 patients with cancer.
Disease: anorexia/cachexia in patients with advanced non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: North America, Europe, Russia, Australia and the Middle East
Trial
details: The anamorelin clinical program includes two pivotal Phase III studies to be run in parallel, named ROMANA-1 and ROMANA-2. Each is a randomized, double-blind, placebo controlled, multicenter global trial that is expected to enroll up to 477 patients each in 15 countries, with sites in North America, Europe, Russia, Australia and the Middle East. The primary efficacy endpoints of ROMANA-1 and 2 include a measure of difference in the change in lean body mass and muscle strength in patients with advanced NSCLC-associated weight loss. Pharmacokinetic and additional safety measures will also be evaluated. The Company expects to complete enrollment in ROMANA-1 and ROMANA-2 in the second half of 2013, with results being reported in early 2015.
In addition, patients will have the option of continuing treatment in a 12-week safety extension study called ROMANA-3. The ROMANA-3 safety extension study is recruiting patients who have successfully completed ROMANA 1 or ROMANA 2,
The ROMANA clinical studies are intended to measure the change in lean body mass and muscle strength in patients with advanced NSCLC-associated weight loss.
Latest
news: * On October 30, 2014, Helsinn Group announced that anamorelin, its investigational novel once-daily ghrelin receptor agonist for the treatment of cancer anorexia-cachexia syndrome (CACS), delivered significant improvements in lean body mass [LBM; one of two primary endpoints] in ROMANA 1, a pivotal 12-week Phase III study in non-small cell lung cancer (NSCLC) patients. The results underscore the potential for treatment with anamorelin to support the care of patients with CACS, a poorly-understood and debilitating condition that affects a majority of advanced cancer patients but for which existing treatment approaches are limited. In the ROMANA 1 trial, over the course of the study, patients treated with anamorelin demonstrated an increase in body weight along with improvements in patient symptoms and concerns, such as appetite, early satiety and fatigue. In ROMANA 1 patients with unresectable Stage III/IV NSCLC, ECOG score of 0-2 and cachexia (≥5% weight loss within six months or BMI <20 kg/m), were randomized (2:1) to 100 mg anamorelin or placebo, given daily orally for 12 weeks. Patients were permitted to receive chemotherapy while on study. Co-primary endpoints were change from baseline over 12 weeks in LBM (measured by DXA) and in handgrip strength. Secondary endpoints included change in body weight and quality of life outcomes assessed by the FAACT (Functional Assessment of Anorexia/Cachexia Therapy) and FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaires. Safety assessments included lab values and adverse events. Anamorelin significantly increased LBM compared with placebo (median change from baseline of 1.10 kg [95% CI 0.76; 1.42] vs -0.44 kg [95% CI -0.88; 0.20]; p<0.0001). Body weight also increased with anamorelin vs placebo (2.20±0.3 vs 0.14±0.4 kg; p<0.0001). Differences between treatment groups relating to handgrip strength were not statistically significant. Over the 12-week treatment period, FAACT scores were significantly higher in the anamorelin arm than in the placebo arm (change from baseline of 4.12±0.8 vs 1.92±0.8; p=0.0004); scores were also higher at all time points after treatment was started. For fatigue, FACIT-F scores deteriorated progressively in the placebo arm during the course of the study but remained stable in the anamorelin arm. The difference between treatment groups was significant at the end of the treatment period. Changes from baseline in FACIT-F scores at week 9 were 0.33±0.9 vs -1.50±1.0 (p=0.0331) for anamorelin vs placebo, respectively and at week 12 were 0.48±1.0 vs -2.10±1.0 (p=0.0244). The most frequent drug-related adverse events included hyperglycemia and nausea, affecting 5.3% and 3.8% of anamorelin treated patients, respectively. Drug-related serious adverse events affected less than 1% of patients. * On December 7, 2011, Helsinn has announced that its US subsidiary, Helsinn Therapeutics Inc., has enrolled the first patient in ROMANA-3, the Company’s 12-week safety extension study. * On August 23, 2011, Helsinn has announced that its US subsidiary, Helsinn Therapeutics, has enrolled the first patient in the company’s pivotal Phase III clinical program of anamorelin HCl for the treatment of anorexia/cachexia in patients with advanced non small cell lung cancer (NSCLC).
