Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

Summary

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

Timeline

Start

2022-11-21

Primary completion

2024-03-13

Completion

2025-04-23

Outcome

Met primary endpoint

paper At 12 weeks, patients in the ponsegromab groups had significantly greater weight gain than those in the placebo group PMID 39282907 ↗

release “met its primary endpoint of change from baseline in body weight compared to placebo in people with cancer cachexia and elevated levels of GDF-15” pfizer.com ↗

Publications

• Groarke JD, Crawford J, Collins SM, Lubaczewski S, Roeland EJ, Naito T, Hendifar AE, Fallon M, Takayama K, Asmis T, Dunne RF, Karahanoglu I, Northcott CA, Harrington MA, Rossulek M, Qiu R, Saxena AR. Ponsegromab for the Treatment of Cancer Cachexia. N Engl J Med. 2024 Dec 19;391(24):2291-2303. doi: 10.1056/NEJMoa2409515. Epub 2024 Sep 14.
• Groarke JD, Crawford J, Collins SM, Lubaczewski SL, Breen DM, Harrington MA, Jacobs I, Qiu R, Revkin J, Rossulek MI, Saxena AR. Phase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC-1 study design. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1054-1061. doi: 10.1002/jcsm.13435. Epub 2024 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ponsegromab	Monoclonal antibody	100 mg	Subcutaneous
Subject	ponsegromab	Monoclonal antibody	200 mg	Subcutaneous
Subject	ponsegromab	Monoclonal antibody	400 mg	Subcutaneous

Indications