HUTCHMED has commenced the Phase III stage of its ongoing Phase II/III clinical trial assessing the combination of surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC), an aggressive form of cancer, in China.
The focus of this trial is the safety and efficacy of the surufatinib and camrelizumab regimen in this patient group. The first patient received a dose on 30 December 2025.
The randomised, active-controlled, multi-centre, open-label Phase II/III trial compares surufatinib plus camrelizumab, nab-paclitaxel, and gemcitabine (S+C+AG) to nab-paclitaxel and gemcitabine (AG) in adults with previously untreated metastatic pancreatic cancer.
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The Phase II portion enrolled 62 patients, with Phase III aiming to enrol nearly 400 additional patients. The primary endpoint for the Phase III segment is overall survival, with secondary endpoints including objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), duration of response, safety, and quality of life.
China Pharmaceutical University Nanjing Tianyinshan Hospital professor Shukui Qin is leading the study, alongside Tianjin Medical University Cancer Institute and Hospital professor Jihui Hao.
Findings from Phase II were shared at the 2025 European Society for Medical Oncology Asia Congress. By 24 July 2025, the median duration of PFS follow-up reached 8.15 months.
Patients receiving S+C+AG achieved a median PFS of 7.20 months, whereas the AG group had 5.52 months, representing a 50.1% reduction in progression or death risk.
In August 2025, HUTCHMED completed subject enrolment in the randomised Phase III SANOVO trial in China, which evaluated the combination of Orpathys (savolitinib) and Tagrisso (osimertinib) as a first-line treatment for specific non-small cell lung cancer (NSCLC) patients.
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