Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ponsegromab · 4 trials · 9 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 \[magnetic resonance imaging\])
AUCinf was defined as area under the serum concentration-time profile from time 0 extrapolated to infinite time.
AUClast was defined as area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.
Cmax was defined as maximum observed concentration. Cmax was observed directly from data.
Tmax was defined as time for Cmax. Tmax was observed directly from data as time of first occurrence.
t1/2 was defined as terminal half life. t1/2 was calculated as Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.
| 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 |
| Ponsegromab low dose | EXPERIMENTAL | - |
| Ponsegromab high dose | EXPERIMENTAL | - |
| 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 antibody being studied for cachexia, a condition of severe weight loss and muscle wasting, in patients with cancer. It is also being evaluated in non-small cell lung cancer (NSCLC) and metastatic pancreatic ductal adenocarcinoma, where it targets cancer-related weight loss and fatigue.
Ponsegromab is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in cancer patients with cachexia.
Ponsegromab is in clinical development, with trials listed as Phase 1 and Phase 2. It is an investigational drug and has not been approved by regulatory authorities. Studies are ongoing or completed to assess its effects in healthy volunteers and in patients with cancer-related cachexia.
Ponsegromab has been studied in several clinical trials. NCT05546476 evaluated its efficacy and safety in cancer patients with cachexia and elevated GDF-15. NCT05685264 examined how the drug is processed in healthy Chinese adults. NCT06989437 is recruiting patients with metastatic pancreatic cancer and weight loss, and NCT07663630 is planned for lung cancer-associated weight loss.
Ponsegromab is an antibody that targets GDF-15, a protein associated with cachexia. Clinical trials have specifically enrolled patients with elevated GDF-15 levels, indicating that the drug's mechanism is linked to this biomarker. However, it is not described as being the same as any other named therapy.
Ponsegromab trials have enrolled a total of 982 participants across studies. One trial, NCT05546476, is completed with 187 patients. NCT05685264 is also completed with 18 healthy volunteers. NCT06989437 is currently recruiting, and NCT07663630 is not yet recruiting, with planned enrollment of 80 patients.