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    ORAL 29 - MASCC-IASLC Joint Session: Palliative and Supportive Care (ID 136)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Palliative and Supportive Care
    • Presentations: 1
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      ORAL29.01 - Results From Phase III Trials of Anamorelin in Advanced Non-Small Cell Lung Cancer Patients with Cachexia: ROMANA 1 and 2 (ID 1359)

      16:45 - 16:56  |  Author(s): J. Friend

      • Abstract
      • Presentation
      • Slides

      Background:
      Cachexia is a debilitating condition often observed in patients with advanced non-small cell lung cancer (NSCLC). A decrease in body weight (BW), in particular loss of lean body mass (LBM), is a primary characteristic, and is associated with worsening functional status, quality of life, and survival. Despite the high prevalence and substantial clinical impact of cachexia in patients with advanced cancer, limited therapeutic options exist. Anamorelin is a novel, orally active, selective ghrelin receptor agonist that mimics the appetite-enhancing and anabolic effects of ghrelin. ROMANA 1 and 2 are two randomized, double-blind, Phase III trials evaluating the efficacy and safety of anamorelin in patients with advanced NSCLC and cachexia.

      Methods:
      In ROMANA 1 (NCT01387269; N=484) and ROMANA 2 (NCT01387282; N=495), patients with unresectable stage III/IV NSCLC and cachexia (≥5% weight loss during prior 6 months or body mass index <20kg/m[2]) were randomized (2:1) to anamorelin 100 mg daily or placebo, for 12 weeks. Co-primary endpoints were change in LBM and handgrip strength (HGS) over 12 weeks. Secondary endpoints included change in BW and in the anorexia/cachexia domain of the Functional Assessment of Anorexia/Cachexia Therapy questionnaire over 12 weeks, and pooled 1-year overall survival (OS) from both studies. Exploratory endpoints included summarizing the incidence of patients who maintained/gained LBM from baseline during 12 weeks by treatment group. Post-hoc analysis compared OS data in patients who had decrease in LBM during 12 weeks versus those who maintained/gained LBM. Safety and tolerability of anamorelin were also evaluated.

      Results:
      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 OS 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 BW (2.20 vs 0.14 kg; p<0.001, and 0.95 vs –0.57 kg; p<0.001), and had 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%).

      Conclusion:
      Anamorelin significantly increased LBM and BW, and improved anorexia-cachexia symptoms and concerns, compared with placebo, in patients with advanced NSCLC and cachexia. Change from baseline in HGS was similar in both treatment arms. A significantly greater proportion of patients maintained/gained LBM in the anamorelin arm versus the placebo arm. When LBM was stable or increased, OS was significantly improved. Anamorelin treatment over 12 weeks was also well tolerated.

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