LY2495655, an antimyostatin antibody, in pancreatic cancer: a randomized, phase 2 trial
Open accessAbstract
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. 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 overall survival: the hazard ratio was 1.70 (90% confidence interval, 1.1–2.7) for 300 mg vs. placebo and 1.3 (0.82–2.1) for 100 mg vs. placebo (recommended doses). Progression‐free survival results were consistent with the overall survival results. A numerically higher hazard ratio was observed in patients with weight loss (WL) of ≥5% (cachexia) than with <5% WL within 6 months before randomization. Subgroup analyses for patients stratified by WL in the 6 months preceding enrollment suggested that functional responses to LY2495655 (either dose) may have been superior in patients with <5% WL vs. patients with ≥5% WL. Among possibly drug‐related adverse events, fatigue, diarrhoea, and anorexia were more common in LY2495655‐treated than in placebo‐treated patients. Conclusions: In the intention‐to‐treat analysis, LY2495655 did not confer clinical benefit in pancreatic cancer. Our data highlight the importance of assessing survival when investigating therapeutic management of cachexia and support the use of WL as a stratifier (independent of performance status).
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Myostatin inhibitors display no significant improvement of survival in cancer patients.
“However, myostatin inhibitors display important side effects when tested in humans93 or display no significant improvement of survival in cancer patients94.”
From Mechanisms of muscle atrophy and hypertrophy: implications in health and disease (2021) · cites this paper as [94]
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- Authors
- Golan, T., Geva, R., Richards, D., Madhusudan, S., Lin, B. K., Wang, H. T., Walgren, R. A., & Stemmer, S. M.
- Affiliations
- Sheba Medical Center (IL)
- Tel Aviv University (IL)
- US Oncology Research Tyler TX USA
- University of Nottingham (GB)
- Eli Lilly (United States) (US)
- Corresponding author
- Walgren, Richard A.
- Venue
- Journal of Cachexia, Sarcopenia and Muscle
- Publisher
- Wiley
- Published
- 2018-07-27
- Volume
- 9
- Issue
- 5
- Pages
- 871-879
- ISSN
- 2190-5991 (ISSN-L)
- 2190-6009
- PMC
- PMC6204586
- OpenAlex
- W2883614888
- Cited by
- 109
- References
- 38
- Citations by year
- 2026: 6 · 2025: 13 · 2024: 11 · 2023: 19 · 2022: 19 · 2021: 16 · 2020: 12 · 2019: 11 · 2018: 2
- FWCI
- 4.04
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal of Cachexia Sarcopenia and Muscle (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Nottingham ePrints (University of Nottingham) (submittedVersion, cc-by-nc)
- Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by-nc)
- Funders
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Health Sciences › Medicine › Physiology › Nutrition and Health in Aging
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Muscle Physiology and Disorders
- Keywords
- myostatin, pancreatic cancer, cachexia, weight loss, chemotherapy, overall survival, progression-free survival, fatigue, anorexia, diarrhea
- MeSH terms
- Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Male, Middle Aged, Neoplasm Staging, Pancreatic Neoplasms, Prognosis, Survival Analysis, Treatment Outcome, Retreatment, Antibodies, Monoclonal, Humanized
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