HUTCHMED (NASDAQ:HCM) announced today that it has initiated the Phase III stage 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 their initial dose on December 30, 2025.
The multicenter, randomized, open-label, active-controlled trial compares the four-drug regimen against nab-paclitaxel plus gemcitabine alone in adults with metastatic pancreatic cancer who have not previously received systemic anti-tumor therapy.
The Phase III portion plans to enroll approximately 400 additional patients, following the completion of the Phase II stage which included 62 patients.
The primary endpoint is overall survival (OS).
Encouraging results from the Phase II part showed notable improvements in key efficacy measures for the combination arm.
Median progression-free survival (PFS) reached 7.20 months compared to 5.52 months in the control arm, with a hazard ratio (HR) of 0.499 and a p-value of 0.0407.
The objective response rate (ORR) was 67.7% versus 41.9% (p=0.0430), and the disease control rate (DCR) stood at 93.5% versus 71% (p=0.0149).
Overall survival data remained immature at the time, with median OS not reached in the combination arm versus 8.48 months in the control (unstratified HR 0.555).
On the safety front, grade 3 or higher treatment-emergent adverse events occurred in 80.6% of patients in the combination arm compared to 61.3% in the control arm, reflecting the intensified regimen.
Surufatinib, marketed in China as SULANDA®, is an oral angio-immuno kinase inhibitor targeting VEGFR, FGFR, and CSF-1R to inhibit angiogenesis and modulate the immune response against tumors.
Camrelizumab is a PD-1 inhibitor developed by Jiangsu Hengrui Pharmaceuticals.
Metastatic PDAC remains a challenging disease with poor prognosis, where fewer than 20% of patients survive beyond one year.
This advancement represents a potential step forward in addressing an area of high unmet need.