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What is next after anamorelin?
1aGeriatric Research, Education and Clinical Center (GRECC), VA Puget Sound Healthcare System bDepartment of Medicine, Division of Gerontology & Geriatric Medicine, University of Washington School of Medicine, Seattle, Washington, USA.
Purpose Of Review:
In spite of its relevance, treatments for the cancer anorexia and cachexia syndrome (CACS) are not available. One of the agents that recently reached phase III clinical trials is anamorelin. Its development, along with that of other agents for this indication, will be reviewed here, with a focus on the gaps in the current knowledge and future directions.
Recent Findings:
In spite of several targets showing promising results in early development, their difficulties obtaining regulatory approval underscore the need to reconsider the current strategies in drug development and the challenges in the field of CACS.
Summary:
Further research is needed in order to meet the challenges of developing treatments for CACS. Preclinical studies should expand our understanding about key regulators of appetite, muscle, and energy metabolism in this setting using models that can be translated reliably to humans. Clinical research efforts should focus on validating the entry criteria, endpoints, outcomes, and the potential synergistic effects and interaction between different targets, nutrition, and exercise interventions. Clinical meaningfulness and significance should be taken into account in the design of clinical trials. It is essential that all key stakeholders are included in the design of future strategies.
Insights
Effective treatments for cancer anorexia and cachexia syndrome (CACS) are lacking. Further research into preclinical models and clinical trial design is crucial for developing new therapies for CACS.
Area of Science:
- Oncology
- Pharmacology
- Metabolism
Background:
- Cancer anorexia and cachexia syndrome (CACS) significantly impacts patient quality of life.
- Current treatments for CACS are limited, highlighting an unmet medical need.
Purpose of the Study:
- To review the development of anamorelin and other agents for CACS.
- To identify knowledge gaps and future research directions in CACS treatment.
Main Methods:
- Review of anamorelin's phase III clinical trial development.
- Analysis of current drug development strategies for CACS.
Main Results:
- Despite promising preclinical results, several CACS drug candidates face regulatory approval challenges.
- Revisiting drug development strategies and addressing field challenges are necessary.
Conclusions:
- Further preclinical research is needed to understand appetite, muscle, and energy metabolism regulators in CACS.
- Clinical research should focus on validating trial criteria, endpoints, and interventions like nutrition and exercise.
- Future strategies must incorporate clinical meaningfulness and stakeholder input.
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