ONO-7643/anamorelin associated with significant improvements in cachexia symptoms in Japanese patients with advanced NSCLC

Most (~70%) patients with advanced cancer suffer from the distressing symptoms of cancer cachexia.

  • Date: 08 Oct 2016

Characterised by weight loss—primarily lean body mass (LBM)—and anorexia, cancer cachexia is associated with a poor prognosis and poor quality of life (QoL).

Today, Dr Junji Uchino from Fukuoka University School of Medicine, Japan, will report the findings of a phase II double-blind study of the first-in-class selective ghrelin receptor agonist, ONO-7643/anamorelin, for the treatment of cachexia in Japanese patients with non-small-cell lung cancer (NSCLC; Abstract 1434O). Anamorelin is a mimetic of ghrelin; the so-called ‘hunger hormone’ secreted by the stomach. The binding of anamorelin to ghrelin receptors stimulates the release of the growth hormone, resulting in enhanced appetite, increased food intake and anabolic effects.

In this confirmatory study of 173 patients with advanced NSCLC (63% stage IV) randomised to 100 mg anamorelin or placebo orally once daily for 12 weeks, anamorelin significantly increased LBM versus placebo (p<0.0001). Significant improvements in body weight (p<0.0001) and anorexia symptoms (p<0.05) were also noted with anamorelin versus placebo, and the treatment was well tolerated over the 12-week study period.

Importantly, these data reflect those from anexploratory phase II Japanese study of NSCLC patients that also reported improvements in QoL with anamorelin versus placebo, and two multinational phase III trials (ROMANA 1 and 2) conducted in the USA, Europe and Australia.

Cachexia may affect the majority of patients with advanced cancer. It is a multifactoria syndrome that impacts many organs and is often irreversible. While nutritional counselling and physical training may delay or prevent cachexia from developing, these interventions have limited effect. Notably, there are no definitive pharmacological treatments to target the relevant elements of cachexia. Anamorelin represents a new drug class and the first effective agent in this patient group, whose therapeutic options are currently limited. Anamorelin is presently under review for potential marketing authorisation in Europe.

Dr Uchino will give a full presentation of these data this evening during the Proffered Papers Session ‘Supportive and palliative care’ (16.30 – 18.00, Oslo).

  1. von Haehling S, Anker SD. J CachexSarcopenia Muscle 2010;1:1–5
  2. Takayama K, et al. Support Care Cancer 2016;24:3495–505
  3. Temel SA, et al. J Clin Oncol 2015;33 (Suppl 15):9500

This article appeared in the Saturday edition of the Daily Reporter