Abstract 65P
Background
Pancreatic cancer (PaC) is a highly lethal malignant tumor. There are limited treatment options for metastatic pancreatic cancer (mPaC) patients, especially for third-line treatment. So, there is still an urgent need to improve the survival of the late-line treatment of mPaC. Fruquintinib (a highly selective vascular endothelial growth factor receptor [VEGFR] inhibitor) showed promising antitumor activity in both preclinical and clinical studies. Fruquintinib promotes tumor vascular normalization and improves tumor immunosuppressive microenvironment, potentially improving mPaC survival.
Methods
This is a phase II multicenter, open-label clinical study. Advanced/metastatic pancreatic adenocarcinoma patients who experienced ≥2 lines of standard chemotherapy received fruquinitinib 5 mg orally once daily. The primary endpoint is progress-free survival, secondary endpoint are overall survival (OS), objective response rate (ORR) per RECIST v1.1, disease control rate (DCR), and safety (NCT05257122).
Results
From February 2022 to October 31st, 2023, 10 eligible pts (8 males) with a median age of 65 (range 48-76) were enrolled; 70% of the enrolled pts were in 3-line treatment. The ORR was 30%, with 3 confirmed partial response (PR), and media progress-free survival (mPFS) was 89.0 days (95% CI 21.8-156.2). The most common treatment-emergent adverse events (TEAEs) were proteinuria (12%) and hypertension (12%). The Grade 3 TEAEs occurred in 3 pts. Of the 10 pts, 3 pts with PR experienced prolonged PFS (ranging from 324 days -NR), all with primary lesion resection before enrollment; 2 of the 3 pts discontinued the treatment due to COVID-19 infection.
Conclusions
Fruquintinib monotherapy as third-line therapy for advanced pancreatic cancers showed potential benefits and manageable safety, especially for patients with primary site resection.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Hutchmed.
Disclosure
W. Guo: Financial Interests, Personal, Research Grant: Hutchmed Inc. All other authors have declared no conflicts of interest.