HUTCHMED Launches Phase III Clinical Trial for Advancing Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
January 05, 2026 - HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13) has officially launched the Phase III segment of its clinical trial evaluating a novel combination therapy for treatment-naïve patients suffering from metastatic pancreatic ductal adenocarcinoma (PDAC) in China.
Background on Pancreatic Ductal Adenocarcinoma
PDAC is recognized as one of the most aggressive cancers, comprising over 90% of all pancreatic cancer cases globally. In 2022, approximately 511,000 individuals were diagnosed with pancreatic cancer worldwide, leading to around 467,000 deaths that year. The five-year survival rate for PDAC is alarmingly low, at less than 10%.
Specifically, in China, an estimated 119,000 new cases were reported in 2022, resulting in around 106,000 fatalities. Despite existing treatment options such as chemotherapy and surgery, less than 20% of patients with metastatic PDAC survive beyond one year.
Phase III Trial Details
The newly initiated Phase III trial is a multicenter, randomized, open-label, active-controlled study aimed at assessing the efficacy and safety of a combination regimen consisting of surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine, referred to as "S+C+AG". This will be compared to the standard treatment of nab-paclitaxel plus gemcitabine ("AG") for adults who have not previously received systemic anti-tumor therapy.
- Total Phase II Participants: 62
- Projected Phase III Enrollments: Approximately 400 additional patients
- Primary Endpoint: Overall survival (OS)
- Secondary Endpoints: Progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life, and safety.
The first patient was dosed on December 30, 2025. Prominent investigators, Professor Shukui Qin and Professor Jihui Hao, are leading the study. More information about the trial can be found on clinicaltrials.gov under identifier NCT06361888.
Initial Findings from Phase II Trial
Recent results from the Phase II portion of the trial, presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress, showed promising outcomes. The median progression-free survival (PFS) for the S+C+AG regimen was 7.20 months, which is an improvement over the 5.52 months of PFS observed in the AG arm, indicating a 50.1% reduction in the risk of progression or death.
Other efficacy markers displayed consistent benefits, with an objective response rate of 67.7% for the treatment group compared to 41.9% for AG (p=0.0430) and a disease control rate of 93.5% against 71.0% (p=0.0149). However, safety monitoring revealed that treatment-emergent adverse events of grade 3 or greater occurred in 80.6% of patients in the S+C+AG arm versus 61.3% in the AG arm.
About HUTCHMED and Its Innovations
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is a leading biopharmaceutical firm dedicated to the research and commercialization of targeted therapies and immunotherapies for cancer and immunological conditions. The company's portfolio includes proprietary drugs developed through its extensive research initiatives, with surufatinib marketed in China as SULANDA®.
For additional information about HUTCHMED and its ongoing clinical studies, visit www.hutch-med.com and follow the company on LinkedIn.
Forward-Looking Statements
This release contains forward-looking statements concerning HUTCHMED's expectations regarding surufatinib’s therapeutic potential and further clinical developments. Such statements carry inherent risks and uncertainties that could lead to actual results differing materially.