LY2495655, an antimyostatin antibody in pancreatic cancer: a randomized phase 2 trial

Golan, Talia; Geva, Ravit; Richards, Donald; Madhusudan, Srinivasan; Lin, Boris Kin; Wang, Haofei Tiffany; Walgren, Richard A.; Stemmer, Salomon M.

Abstract

Background: Cachexia is a formidable clinical challenge in pancreatic cancer. We assessed LY2495655 (antimyostatin antibody) plus standard-of-care chemotherapy in pancreatic cancer using cachexia status as a stratifier.

Methods: In this randomized, phase 2 trial, patients with stage II-IV pancreatic cancer were randomized to 300-mg LY2495655, 100-mg LY2495655, or placebo, plus physician-choice chemotherapy from a prespecified list of standard-of-care regimens for first and later lines of care. Investigational treatment was continued during second-line treatment. The primary endpoint was overall survival (OS).

Results: Overall, 125 patients were randomized. In August 2014, 300-mg LY2495655 was terminated due to imbalance in death rates between the treatment arms; in January 2015, 100-mg LY2495655 treatment was terminated due to futility. LY2495655 did not improve OS: the hazard ratio (HR) was 1.70 (90% confidence interval, 1.1–2.7) for 300 mg versus placebo and 1.3 (0.82–2.1) for 100 mg versus placebo (recommended doses). Progression-free survival results were consistent with the OS results. A numerically higher HR was observed in patients with weight loss (WL) of ≥5% (cachexia) than with

Citation

Golan, T., Geva, R., Richards, D., Madhusudan, S., Lin, B. K., Wang, H. T., …Stemmer, S. M. (2018). LY2495655, an antimyostatin antibody in pancreatic cancer: a randomized phase 2 trial. Journal of Cachexia, Sarcopenia and Muscle, 9(5), 871-879. https://doi.org/10.1002/jcsm.12331

• Journal Article Type: Article
• Acceptance Date: Jun 11, 2018
• Online Publication Date: Jul 27, 2018
• Publication Date: Oct 31, 2018
• Deposit Date: Jun 14, 2018
• Publicly Available Date: Jul 27, 2018
• Journal: Journal of Cachexia, Sarcopenia and Muscle
• Print ISSN: 2190-5991
• Electronic ISSN: 2190-6009
• Publisher: Wiley Open Access
• Peer Reviewed: Peer Reviewed
• Volume: 9
• Issue: 5
• Pages: 871-879
• DOI: https://doi.org/10.1002/jcsm.12331
• Keywords: Myostatin; Cachexia; Pancreatic cancer; Muscle mass
• Public URL: https://nottingham-repository.worktribe.com/output/947965
• Publisher URL: https://onlinelibrary.wiley.com/doi/abs/10.1002/jcsm.12331