HUTCHMED (00013) has initiated the Phase III stage study of the combination of surufatinib and camrelizumab for the treatment of newly diagnosed pancreatic ductal adenocarcinoma.

HUTCHMED (00013) announced that the company has initiated the Phase III portion of a Phase II/III study in China for the first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDAC) using surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine. The first patient received their first dose of treatment on December 30, 2025. This study is a multicenter, randomized, open-label, positive-controlled Phase II/III clinical trial designed to evaluate the efficacy and safety of the S+C+AG regimen compared to AG regimen in adult patients with metastatic PDAC who have not received systemic anti-tumor therapy. The study enrolled 62 patients in the Phase II portion and plans to enroll approximately 400 patients in the Phase III portion. The primary endpoint of the Phase III portion is overall survival (OS). Secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety. The principal investigators of this clinical trial are Professor Qin Shukui from Nanjing Tianyinshan Hospital of China Pharmaceutical University and Professor Hao Jihui from Tianjin Medical University Cancer Institute and Hospital. For further details of this study, please visit clinicaltrials.gov and search for registration number NCT06361888. The results of the Phase II portion of the study were recently presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress. As of the data cut-off date of July 24, 2025, the median PFS follow-up time was 8.15 months. The median PFS in the S+C+AG group was 7.20 months, compared to 5.52 months in the AG group (stratified hazard ratio [HR] 0.499, log-rank test p=0.0407), indicating a 50.1% reduction in the risk of disease progression or death. Similar benefits were observed in other key efficacy endpoints, including ORR (67.7% vs. 41.9%, p=0.0430) and DCR (93.5% vs. 71.0%, p=0.0149). Although overall survival data were not yet mature at the time of analysis, a positive trend was observed (not reaching median of 8.48 months, unstratified HR 0.555), with 9 events in the S+C+AG group (N=31) compared to 15 events in the AG group (N=31). Treatment showed manageable safety features, with 80.6% of patients in the S+C+AG group experiencing Grade 3 or higher treatment-emergent adverse events (TEAE), compared to 61.3% in the AG group.