1588P - Anamorelin4s effects on appendicular lean body mass in cancer patients with cachexia; results from a phase II randomized, double blind, multicenter...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Supportive measures
Presenter Josè M. Garcia
Authors J.M. Garcia1, Y. Yan2, E. Duus2, J. Friend2
  • 1Medicine, Baylor College of Medicine/MEDVAMC, Houston/US
  • 2R&d, Helsinn Therapeutics, Inc., Bridgewater/US

Abstract

Background

Cancer cachexia is associated with increased morbidity and poor survival, and is characterized by decreased muscle strength and overall lean body mass including in the extremities (appendicular LBM or aLBM). As most lean tissue in the extremities is striated muscle, aLBM is a good surrogate for muscle mass. Anamorelin is an investigational orally active ghrelin receptor agonist with orexigenic and anabolic activity. We present here a Phase II study post-hoc analysis on a subset of patients who were assessed for aLBM.

Methods

A Phase II trial enrolled patients with advanced cancer, performance score ≤ 2 and weight loss ≥5% within 6 months from enrollment. Patients were randomized to treatment with placebo (PL) or 50mg anamorelin (ANA) once daily for 12 weeks. Eighty-two patients were assessed for total LBM by DXA, handgrip strength (HGS) and Quality of Life (QoL; ASAS scale) at baseline, 4, 8 and 12 weeks. For 72 subjects (N = 38, ANA; N = 34, PL), data was also available for aLBM. Solid tumors represented prevalent malignancy (>93%) with no difference in cancer types between treatment groups

Results

Analysis of aLBM indicated that PL-treated patients lost aLBM in the arms during the whole 12 weeks, while aLBM in the legs was more stable. In ANA-treated patients, aLBM increased significantly in the arms and in the legs. At week 12, the percentage change from baseline of aLBM in arms + legs showed a statistically significant increase in ANA vs PL groups (5.8% and 1.5%, respectively; p < 0.05). HGS change from baseline also improved in ANA-treated patients vs PL although this difference was only significant at 8 weeks. No significant difference in QoL (ASAS score) was observed, but numerically ANA-treated patients were better than PL. ANA was well tolerated, and types and prevalence of AEs were similar between treatment arms.

Conclusion

Decreased LBM and HGS are poor prognostic factors in cancer cachexia patients. This study demonstrates that 50mg ANA treatment for 12 weeks significantly increased aLBM and HGS. Together with the orexigenic activity of ANA, these results support the use of ANA in treating cancer cachexia/anorexia and the evaluation of higher ANA doses.

Disclosure

J.M. Garcia: I receive research support from Helsinn,

Y. Yan: I am an Helsinn employee

E. Duus: I am an Helsinn employee,

J. Friend: I am an Helsinn employee.