HUTCHMED (00013) announced today the initiation of the Phase III portion of its China-based Phase II/III study evaluating surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The first patient received their initial dose on December 30, 2025.

This study is a multicenter, randomized, open-label, active-controlled Phase II/III clinical trial designed to assess the efficacy and safety of the surufatinib plus camrelizumab, nab-paclitaxel, and gemcitabine regimen (S+C+AG) compared to the nab-paclitaxel and gemcitabine regimen (AG) in adult patients with metastatic pancreatic cancer who have not previously received systemic anti-tumor therapy. The Phase II segment enrolled a total of 62 patients, with plans to enroll approximately 400 additional patients in the Phase III portion.

The primary endpoint for the Phase III segment 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 for this clinical trial are Professor Qin Shuukui from Nanjing Tianyinshan Hospital, China Pharmaceutical University, and Professor Hao Jihui from Tianjin Medical University Cancer Institute and Hospital.

Further details of the study can be found by searching for the registration number NCT06361888 on clinicaltrials.gov. Results from 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 cutoff date of July 24, 2025, the median PFS follow-up time was 8.15 months. The median PFS was 7.20 months in the S+C+AG group, 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 for 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 mature at the time of analysis, a positive trend was observed (not reached vs. 8.48 months, unstratified HR 0.555), with 9 events occurring in the S+C+AG group (N=31) and 15 events in the AG group (N=31). The treatment demonstrated a manageable safety profile, with grade 3 or higher treatment-emergent adverse events (TEAEs) occurring in 80.6% of patients in the S+C+AG group, compared to 61.3% in the AG group.