Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ponsegromab · 3 trials · 8 indications
Scale consists of five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher scores are associated with a better outcome.
Body weight was measured in kilograms using a calibrated weighing scale. Baseline was defined as the last average of the duplicate measurements prior to, or on Day 1. The average of the duplicate body weights collected at assessment time was considered. The posterior medians and 90 percent (%) credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for each randomized dose (including placebo). 4-Parameter maximal effect (E max) model: change from baseline = E 0 + (E max \* dose\^Hill) / (ED 50\^Hill + dose\^Hill), where E0 is the placebo effect, E max is the maximum effect, ED 50 is the dose producing 50% of the maximum effect, and Hill is the slope parameter. Model utilized a Bayesian methodology with a robustified, informative meta-analytic predictive prior for the placebo change from baseline at week 12.
Assessed by computer tomography (CT) (or MRI \[magnetic resonance imaging\])
| Arm | Type | Description |
|---|---|---|
| Double-Blind ponsegromab Treatment lower dose | EXPERIMENTAL | ponsegromab 200 mg subcutaneous injection every 4 weeks |
| Double-Blind ponsegromab Treatment higher dose | EXPERIMENTAL | ponsegromab 400 mg subcutaneous injection every 4 weeks |
| Double-Blind Placebo Treatment | PLACEBO_COMPARATOR | Match placebo subcutaneous injection every 4 weeks |
| Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment | EXPERIMENTAL | ponsegromab low dose subcutaneous injection every 4 weeks |
| Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment | PLACEBO_COMPARATOR | Match placebo subcutaneous injection every 4 weeks |
| Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment | EXPERIMENTAL | ponsegromab medium dose subcutaneous injection every 4 weeks |
| Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment | EXPERIMENTAL | ponsegromab high dose subcutaneous injection every 4 weeks |
| Double-Blind ponsegromab Treatment dose | EXPERIMENTAL | Ponsegromab 400 mg subcutaneous injection every 4 weeks |
| Name | Type | Description |
|---|---|---|
| ponsegromab | DRUG | Double-Blind ponsegromab Treatment |
| placebo | DRUG | Double-Blind placebo Treatment |
| Placebo for ponsegromab | DRUG | Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment |
Key inclusion Criteria: * Signed Informed Consent Document * Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma * Cachexia defined by Fearon criteria of weight loss * Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day ...
Ponsegromab is an investigational medicine being studied for cachexia, a condition of significant body weight loss, in people with cancer. Clinical trials have enrolled adults with non-small cell lung cancer, metastatic pancreatic ductal adenocarcinoma, and other advanced cancers who have cachexia, loss of appetite, and fatigue.
Ponsegromab is a monoclonal antibody designed to target GDF-15, a protein also known as growth differentiation factor 15. By binding GDF-15, the antibody is intended to block its activity. Elevated GDF-15 levels have been observed in patients with cancer and cachexia, and the completed Phase 2 trial enrolled patients with elevated GDF-15.
Ponsegromab is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating the antibody in cancer-associated cachexia.
Ponsegromab is in Phase 2 clinical development. One Phase 2 trial has been completed, and a second Phase 2 trial is currently recruiting. A Phase 1 trial in adults with lung cancer-associated significant body weight loss is not yet recruiting. The drug is investigational and has not been approved by the FDA.
Ponsegromab has been studied in three registered trials. NCT05546476 was a completed Phase 2 trial in patients with cancer, cachexia, and elevated GDF-15. NCT06989437 is a recruiting Phase 2 trial in metastatic pancreatic ductal adenocarcinoma with cachexia and fatigue. NCT07663630 is a Phase 1 trial in non-small cell lung cancer with cachexia that is not yet recruiting.
Across the three registered trials, total planned and actual enrollment is 1,249 participants. The completed Phase 2 trial NCT05546476 enrolled 187 patients, the recruiting Phase 2 trial NCT06989437 plans to enroll 982, and the Phase 1 trial NCT07663630 plans to enroll 80. All trials are randomized, double-blind, and placebo-controlled.