HUTCHMED Initiates Phase III for Treatment-Naïve Pancreatic Ductal Adenocarcinoma

HUTCHMED (Nasdaq/AIM: HCM) has initiated the Phase III portion of its Phase II/III trial evaluating surufatinib + camrelizumab + nab-paclitaxel + gemcitabine (S+C+AG) as first-line treatment for metastatic pancreatic ductal adenocarcinoma in China, with the first patient dosed on Dec 30, 2025.

The Phase III plans ~400 additional patients (62 in Phase II). Primary endpoint is overall survival (OS). Phase II results showed median PFS 7.20 vs 5.52 months (HR 0.499, p=0.0407), ORR 67.7% vs 41.9% (p=0.0430) and DCR 93.5% vs 71.0% (p=0.0149). OS was immature (not reached vs 8.48 months, unstratified HR 0.555). Safety: grade ≥TEAEs 80.6% vs 61.3%.

https://www.stocktitan.net/news/HCM/hutchmed-initiates-phase-iii-stage-of-the-ongoing-trial-of-the-j9i62wdjhvlp.html