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 Oct 2016

Session

Supportive and palliative care

Presenters

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

Author affiliations

  • 1 Department Of Respiratory Medicine, Fukuoka University School of Medicine, 814-0180 - Fukuoka/JP
  • 2 Division Of Integrated Oncology, Institute of Biomedical Research and Innovation, 650-0047 - Kobe/JP
  • 3 Department Of Respiratory Medicine, Kyorin university Hospital, Mitaka/JP
  • 4 Division Of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka/JP
  • 5 Respiratory Medicine, Nagoya University, Graduate School of Medicine, 466-8550 - Nagoya/JP
  • 6 Department Of Thoracic Oncology, Kanagawa Cancer Center, Yokohama/JP
  • 7 Department Of Respiratory Medicine, Shikoku Cancer Center, Matsuyama/JP
  • 8 Department Of Clinical Oncology, Japan Anti-Tuberculosis Association, Fukujuji Hospital, kiyose/JP
  • 9 Respiratory Medicine, Nagaoka Red Cross Hospital, 940-2085 - Nagaoka/JP
  • 10 Dept. Of Medical Oncology, Chiba University, School of Medicine, 260-8677 - Chiba/JP
  • 11 Department Of Respiratory Medicine, Kyoto Prefectural University of Medicine, Kyoto/JP
  • 12 Health Science On Supportive Medicine For Intractable Diseases, Teikyo University, Tokyo/JP
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Resources

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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