This international, multicenter, randomized, double-blind Phase 2b/3 study evaluates the efficacy, safety, and tolerability of ponsegromab plus first-line systemic chemotherapy versus placebo plus first-line systemic chemotherapy in adults with cachexia and metastatic pancreatic ductal adenocarcinoma (mPDAC). The co-primary endpoints are percent change from baseline in body weight and change from baseline in the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) 5-item Anorexia Symptom Scale score at Week 12. Eligible participants must have documented mPDAC, cachexia defined according to Fearon criteria, ECOG performance status =1, and completion of one cycle of nab-paclitaxel/gemcitabine or two cycles of FOLFIRINOX before randomization. Participants are randomized 1:1:1 to one of two ponsegromab dose levels or placebo in combination with ongoing first-line chemotherapy. Key secondary endpoints include overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), body composition parameters, patient-reported outcomes, and safety assessments.
This study is evaluating the medicine ponsegromab in people with pancreatic cancer that has spread to other parts of the body and has caused significant weight loss and fatigue. All participants receive standard chemotherapy and are randomly assigned to receive either ponsegromab or a placebo in addition to that treatment. The goal is to find out whether ponsegromab can help improve body weight and symptoms related to loss of appetite. Adults with metastatic pancreatic cancer and cancer-related weight loss who have already completed an initial cycle of standard chemotherapy may be eligible. Neither participants nor their doctors know which additional treatment is being given during the blinded part of the study. Researchers are also assessing safety, tolerability, physical activity, and how the cancer responds to treatment.
