Real-world outcomes of serplulimab-based therapy in unresectable locally advanced or metastatic pancreatic cancer

Immunotherapy benefits many solid tumors, yet efficacy in pancreatic cancer (PC) remains limited given its immunologically cold phenotype. We evaluated the real-world effectiveness, safety, and treatment patterns of serplulimab-based regimens in unresectable locally advanced or metastatic PC. This two-center observational study retrospectively included adults with pathologically confirmed advanced PC who received serplulimab-based therapy as first- or later-line treatment. Short-term efficacy was assessed per RECIST v1.1, safety per CTCAE v5.0, and long-term benefit by overall survival (OS). Among the 42 included patients, 24 received first-line (1 L) therapy and 18 received second-line or later (≥ 2 L) therapy. At a median follow-up of 17.7 months, the objective response rate (ORR) in the 1 L group was 25.0% (95% CI: 9.8–46.7%) and the disease control rate (DCR) was 83.3% (95% CI: 62.6–95.3%); in the ≥2 L group, the ORR was 22.2% (95% CI: 6.4–47.6%) and the DCR was 83.3% (95% CI: 58.6–96.4%). Median progression‑free survival was 6.2 months (95% CI: 4.4–9.3) in the 1 L group and 5.7 months (95% CI: 3.2–NR) in the ≥2 L group. Median OS was 10.3 months (95% CI: 8.0–12.9) in the 1 L group and 9.1 months (95% CI: 5.4–NR) in the ≥2 L group. Adverse events (AEs) occurred in 78.6%, predominantly hematologic; grade 3 or higher immune-related AEs occurred in 4.8%. Serplulimab-based combinations showed preliminary antitumor activity with a manageable safety profile in advanced PC across both first-line and later-line settings. These real-world data generate hypotheses for larger, biomarker-integrated prospective studies to optimize combinations and improve the durability of benefit.