1434O - ONO-7643/anamorelin for the treatment of patients with non-small cell lung cancer and cachexia: results from phase 2 study with Japanese patients

Date 08 October 2016
Event ESMO 2016 Congress
Session Supportive and palliative care
Topics Supportive Measures
Presenter Junji Uchino
Citation Annals of Oncology (2016) 27 (6): 497-521. 10.1093/annonc/mdw390
Authors J. Uchino1, N. Katakami2, T. Yokoyama3, T. Naito4, M. Kondo5, K. Yamada6, H. Kitajima7, K. Yoshimori8, K. Sato9, Y. Takiguchi10, K. Takayama11, K. Eguchi12
  • 1Department Of Respiratory Medicine, Fukuoka University School of Medicine, 814-0180 - Fukuoka/JP
  • 2Division Of Integrated Oncology, Institute of Biomedical Research and Innovation, 650-0047 - Kobe/JP
  • 3Department Of Respiratory Medicine, Kyorin university Hospital, Mitaka/JP
  • 4Division Of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka/JP
  • 5Respiratory Medicine, Nagoya University, Graduate School of Medicine, 466-8550 - Nagoya/JP
  • 6Department Of Thoracic Oncology, Kanagawa Cancer Center, Yokohama/JP
  • 7Department Of Respiratory Medicine, Shikoku Cancer Center, Matsuyama/JP
  • 8Department Of Clinical Oncology, Japan Anti-Tuberculosis Association, Fukujuji Hospital, kiyose/JP
  • 9Respiratory Medicine, Nagaoka Red Cross Hospital, 940-2085 - Nagaoka/JP
  • 10Dept. Of Medical Oncology, Chiba University, School of Medicine, 260-8677 - Chiba/JP
  • 11Department Of Respiratory Medicine, Kyoto Prefectural University of Medicine, Kyoto/JP
  • 12Health Science On Supportive Medicine For Intractable Diseases, Teikyo University, Tokyo/JP

Abstract

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.