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Ponsegromab for the Treatment of Cancer Cachexia.

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  • 1From the Internal Medicine Research Unit (J.D.G., I.K., M.A.H., A.R.S.) and Clinical Pharmacology (R.Q.), Pfizer, Cambridge, MA; Duke Cancer Institute, Duke University Medical Center, Durham, NC (J.C.); Global Biometrics and Data Management, Pfizer R&D UK, Sandwich (S.M.C.), and Edinburgh Cancer Research Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh (M.F.) - both in the United Kingdom; Translational Clinical Sciences, Pfizer, Collegeville, PA (S.L.); Knight Cancer Institute, Oregon Health and Science University, Portland (E.J.R.); the Cancer Supportive Care Center, Shizuoka Cancer Center, Shizuoka (T.N.), and the Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto (K.T.) - both in Japan; Cedars-Sinai Medical Center, Los Angeles (A.E.H.); the Ottawa Hospital Cancer Centre, Ottawa (T.A.); Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY (R.F.D.); Translational Clinical Sciences, Pfizer, Groton, CT (C.A.N.); and the Internal Medicine Research Unit, Pfizer, Tampa, FL (M.R.).

The New England Journal of Medicine
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Ponsegromab, an antibody targeting growth differentiation factor 15 (GDF-15), effectively increased weight and improved activity in cancer cachexia patients. This study confirms GDF-15 drives cancer cachexia, offering a new therapeutic target.

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Area of Science:

  • Oncology
  • Immunology
  • Metabolic Disorders

Background:

  • Cancer cachexia is a debilitating condition linked to increased mortality.
  • Elevated levels of the cytokine growth differentiation factor 15 (GDF-15) are characteristic of cancer cachexia.
  • Preliminary studies suggested ponsegromab, a GDF-15 inhibitor, may improve cachexia symptoms.

Purpose of the Study:

  • To evaluate the efficacy and safety of ponsegromab in treating cancer cachexia.
  • To assess the impact of ponsegromab on body weight, appetite, and physical activity in patients with cancer cachexia.

Main Methods:

  • A 12-week, randomized, double-blind, placebo-controlled phase 2 trial.
  • 187 patients with cancer cachexia and elevated serum GDF-15 levels were randomized to receive ponsegromab (100 mg, 200 mg, or 400 mg) or placebo subcutaneously every 4 weeks.
  • Primary endpoint: change in body weight at 12 weeks; secondary endpoints: appetite, cachexia symptoms, physical activity, and safety.

Main Results:

  • Ponsegromab treatment led to significant weight gain compared to placebo across all tested doses.
  • The 400 mg dose showed notable improvements in appetite, cachexia symptoms, and physical activity.
  • Adverse events were comparable between the ponsegromab and placebo groups, with 70% and 80% reporting events, respectively.

Conclusions:

  • Inhibition of GDF-15 with ponsegromab is an effective strategy for increasing weight gain and improving activity levels in cancer cachexia patients.
  • The findings validate GDF-15's role as a key driver of cancer cachexia.
  • Ponsegromab demonstrates a favorable safety profile, supporting its potential as a therapeutic agent.