HUTCHMED Starts Phase III Trial In China Testing Four-Drug Combo For Metastatic Pancreatic Cancer After First Patient Dosed On Dec 30, 2025

HUTCHMED (China) Limited has begun the Phase III stage of its Phase II/III clinical trial in China. This study is designed to assess whether a treatment that combines surufatinib, camrelizumab, nab-paclitaxel and gemcitabine can serve as an effective first-line therapy for patients diagnosed with metastatic pancreatic ductal adenocarcinoma (PDAC). The first patient in this new phase received treatment on December 30, 2025.

PDAC is the most common and aggressive form of pancreatic cancer, accounting for more than 90 percent of all cases. It remains one of the deadliest cancers worldwide. In 2022, approximately 511,000 people were diagnosed with pancreatic cancer globally, and around 467,000 died from the disease. Survival rates remain low, with fewer than 10 percent of patients living beyond five years. In China, pancreatic cancer led to an estimated 119,000 new cases and roughly 106,000 deaths in 2022. Standard approaches such as chemotherapy, radiation and surgery have not been able to significantly improve outcomes, and less than one-fifth of patients with metastatic disease survive for more than a year.

The ongoing trial is a multicenter, randomized, open-label and active-controlled study. It is comparing the four-drug combination, referred to as S+C+AG, with the current standard regimen of nab-paclitaxel and gemcitabine (AG). The study includes adults with metastatic pancreatic cancer who have not received any prior systemic treatment for their condition. In the Phase II portion, 62 patients were enrolled. The Phase III part plans to include approximately 400 additional patients. 

The main objective of this stage is to evaluate overall survival. Other key measures include progression-free survival, objective response rate, duration of response, disease control rate, safety and quality of life. The study is being led by Professor Shukui Qin from China Pharmaceutical University Nanjing Tianyinshan Hospital and Professor Jihui Hao from Tianjin Medical University Cancer Institute and Hospital. Further information is available on clinicaltrials.gov under the identifier NCT06361888.

Findings from the Phase II portion were recently presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress. As of the data cut-off on July 24, 2025, the median follow-up for progression-free survival was 8.15 months. The S+C+AG combination showed a median progression-free survival of 7.20 months, compared with 5.52 months in the AG group. This represented a 50.1 percent reduction in the risk of disease progression or death, based on a stratified hazard ratio of 0.499. 

The combination also performed better in other important measures, including objective response rate (67.7 percent versus 41.9 percent) and disease control rate (93.5 percent versus 71.0 percent). Although overall survival data were still early at the time of analysis, results showed a positive trend, with the survival curve not yet reached for the S+C+AG group compared with 8.48 months for the AG group. Safety results showed that treatment-emergent adverse events of grade 3 or above occurred in 80.6 percent of patients in the S+C+AG group, compared with 61.3 percent in the AG group.