HUTCHMED has advanced its ongoing study of surufatinib and camrelizumab for treatment‑naïve metastatic pancreatic ductal adenocarcinoma, initiating the phase 3 stage of its phase 2/3 trial in China. The company confirmed that the first patient received a dose on 30 December 2025.
Pancreatic ductal adenocarcinoma is the most common and aggressive form of pancreatic cancer, accounting for more than 90% of cases. Globally, around 511,000 people were diagnosed with pancreatic cancer in 2022 and approximately 467,000 died from the disease. Survival remains poor, with fewer than 10% of patients living five years after diagnosis.
In China, 119,000 cases and 106,000 deaths were recorded in 2022. Standard treatments such as chemotherapy, surgery and radiotherapy have delivered limited improvements, and fewer than one in five patients with metastatic disease survive beyond a year.
The multicentre, randomised, open‑label trial is comparing a four‑drug combination of surufatinib, camrelizumab, nab‑paclitaxel and gemcitabine with the established regimen of nab‑paclitaxel plus gemcitabine. Sixty‑two patients were enrolled in the phase 2 portion, and the phase 3 stage aims to recruit around 400 more.
Overall survival is the primary endpoint, with secondary measures including progression‑free survival, objective response rate, duration of response, disease control rate, quality of life and safety. The study is led by Professor Shukui Qin of China Pharmaceutical University Nanjing Tianyinshan Hospital and Professor Jihui Hao of Tianjin Medical University Cancer Institute and Hospital.
Data from the phase 2 stage, presented at the 2025 ESMO Asia Congress, showed a median progression‑free survival of 7.20 months for the combination therapy compared with 5.52 months for the control arm, representing a 50.1% reduction in the risk of progression or death. Improvements were also seen in objective response rate and disease control rate.
Overall survival data were immature but indicated a favourable trend. The safety profile was manageable, with higher rates of grade 3 or above adverse events in the combination arm but no unexpected findings.
