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pegilodecakin + FOLFOX is an experimental combination therapy investigated for metastatic pancreatic ductal adenocarcinoma (PDAC), especially as second-line treatment for patients progressing after gemcitabine-based therapy. Pegilodecakin (AM0010) is a pegylated recombinant human interleukin-10 (IL-10) designed to stimulate anti-tumor immunity, specifically enhancing CD8+ T cell survival, proliferation, and cytotoxic activity. FOLFOX is a chemotherapy regimen that combines folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin, exerting cytotoxic effects via DNA synthesis inhibition and DNA cross-linking. The combination was designed to synergize chemotherapy-induced immunogenic cell death with IL-10-mediated immune activation; however, large phase 3 clinical trials did not demonstrate an improvement in overall survival or progression-free survival compared to FOLFOX alone, although immunomodulatory effects (e.g., increases in IFN-γ, IL-18, granzyme B, and reduction of TGF-β) were observed. Toxicities were manageable, though anemia and thrombocytopenia were more frequent with the combination[2][4][1][3][5].
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