Highlights

  • HUTCHMED starts Phase III study of surufatinib and camrelizumab combination in PDAC.
  • Phase II results show 50% lower risk of progression compared to standard therapy.
  • Trial targets ~400 patients to assess survival, response, and safety outcomes.

HUTCHMED Limited (Nasdaq:HCM) has initiated the Phase III segment of its ongoing Phase II/III trial evaluating the combination of surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine (S+C+AG) as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in China. The first patient in this phase received the initial dose on December 30, 2025.

Disease Overview
PDAC accounts for over 90% of pancreatic cancer cases and is associated with poor prognosis. Globally, an estimated 511,000 people were diagnosed with pancreatic cancer in 2022, resulting in approximately 467,000 deaths. The five-year survival rate remains below 10%. In China, roughly 119,000 diagnoses and 106,000 deaths were reported in 2022. Conventional therapies such as chemotherapy, surgery, and radiation have shown limited improvement in patient outcomes. Fewer than 20% of patients with metastatic pancreatic cancer survive beyond one year.

Study Design
The Phase II/III study is multicenter, randomized, open-label, and active-controlled. It compares the S+C+AG combination against nab-paclitaxel plus gemcitabine (AG) in adults with metastatic pancreatic cancer who have not received prior systemic anti-tumor therapy. The Phase II part enrolled 62 patients, while the Phase III portion plans to recruit approximately 400 additional participants.

The primary endpoint of Phase III is overall survival (OS). Secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), safety, and quality of life. Leading principal investigators include Professor Shukui Qin of China Pharmaceutical University Nanjing Tianyinshan Hospital and Professor Jihui Hao of Tianjin Medical University Cancer Institute and Hospital.

Phase II Results
Results from the Phase II part, presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress, showed a median PFS of 7.20 months for the S+C+AG arm versus 5.52 months for the AG arm, reflecting a 50.1% reduction in the risk of progression or death (stratified HR 0.499, p=0.0407). The ORR was 67.7% compared with 41.9% for AG (p=0.0430), and the DCR was 93.5% versus 71.0% (p=0.0149). Overall survival data were immature, though a favorable trend was noted. Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 80.6% of S+C+AG patients versus 61.3% in the AG group.

Share Price Snapshot
HCM was trading at USD13.65 per share as of 04 January 2026