Abstract 1401
Background
Cancer cachexia occurs in approximately 70% of advanced cancer patients and is characterized by loss of weight, mainly lean body mass (LBM) and anorexia. Furthermore, cancer cachexia may also be accompanied by poor prognosis and poor quality of life (QOL). ONO-7643/anamorelin (ANAM) is a novel selective ghrelin receptor agonist with appetite-enhancing and anabolic activity, leading to increase of LBM (body weight).
Methods
ONO-7643-04 was a double-blind, phase 2 trial to confirm ANAM efficacy and safety in Japanese patients with unresectable stage III/IV non-small cell lung cancer (NSCLC), ECOG performance status 0-2 and cachexia (main criteria: ≥5% weight loss within prior 6 months). The influence of ANAM on motor function was also investigated in an exploratory manner. Patients were randomized to 100 mg ANAM or placebo, given daily orally for 12 weeks. Primary endpoint was change in LBM (measured by DXA) over 12 weeks from baseline. Secondary endpoints included change in appetite, body weight, QOL assessment (QOL-ACD), hand grip strength (HGS) and 6-minute walk test (6MWT).
Results
Demographics were balanced (N = 173); median age = 67 yr, male (66.5%), ECOG PS = 2 (12.7%) and stage IV (63.0%). Treatment effects: ANAM significantly increased LBM vs placebo (p
Conclusions
ANAM significantly increased LBM (body weight), and improved anorexia symptoms and nutritional state. Subset analysis between responders and non-responders provided further evidence of the clinical benefit associated with maintaining/increasing LBM.
Clinical trial identification
JapicCTI-142451
Legal entity responsible for the study
Ono Pharmaceutical Co., Ltd.
Funding
Ono Pharmaceutical Co., Ltd.
Disclosure
J. Uchino, T. Yokoyama, T. Naito, M. Kondo: Corporate-Sponsored Research: Ono Pharmaceutical Co., Ltd. Honoraria or Consultation Fees: Ono Pharmaceutical Co., Ltd. N. Katakami: Corporate-Sponsored Research:Ono, AstraZeneca, Eisai, Kyowa Hakko Kirin, Shionogi, Daiichi Sankyo, Taiho, Chugai, Eli Lilly, Boehringer Ingelheim, Merck Serono. Honoraria or Consultation Fees: Ono, Chugai, Boehringer Ingelheim, AstraZeneca, Eli Lilly, Taiho. K. Yamada: Corporate-Sponsored Research: Ono Pharmaceutical Co., Ltd. Receipt of Grants/Research Supports: Ono Pharmaceutical Co., Ltd. Honoraria or Consultation Fees: Ono Pharmaceutical Co., Ltd. H. Kitajima, K. Yoshimori, K. Sato: Corporate-Sponsored Research: Ono Pharmaceutical Co., Ltd. Receipt of Grants/Research Supports: Ono Pharmaceutical Co., Ltd. Y. Takiguchi: Membership on Advisory Board: Ono Pharmaceutical Co., Ltd. Receipt of Grants/Research Supports: Ono Pharmaceutical Co., Ltd. Honoraria or Consultation Fees: Ono Pharmaceutical Co., Ltd. K. Takayama: Membership on Advisory Board: Ono Pharmaceutical Co., Ltd. Corporate-Sponsored Research: Ono Pharmaceutical Co., Ltd. Honoraria or Consultation Fees: Ono Pharmaceutical Co., Ltd. K. Eguchi: Corporate-Sponsored Research: Ono Pharmaceutical Co., Ltd.
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