IL-1 receptor accessory protein (IL1RAP)-targeting antibody nadunolimab, in combination with gemcitabine and nab-paclitaxel (GN), demonstrates promising treatment efficacy and manageable safety in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), according to data published in Clinical Cancer Research.
The study evaluated patients with locally advanced, metastatic PDAC that was previously untreated. Every two weeks, participants were administered nadunolimab (1.0-7.5 mg/kg) with a standard dose of GN. In addition, the study explored clinical response, serum and tumor biomarkers, and any associated correlations.
Researchers reviewed safety as the primary objective, with secondary objectives of progression-free survival (PFS), anti-tumor response, and overall survival (OS).
The study enrolled 76 patients aged 43 to 89 years. The median age was 63 years, 42% were female, 97% presented with metastatic PDAC, and 9% underwent adjuvant chemotherapy.
Of the adverse events that occurred during the study, only one patient experienced grade 3 peripheral neuropathy or above. 29% of patients experienced an infusion-related reaction (Grade 3, 3%), and neutropenia was the most frequent adverse event greater than or above grade 3, which typically occurred during the first treatment cycle.
The median iPFS (iRECIST) was 7.2 months (95% CI, 5.2-8.5) and the median OS was 13.2 months (95% CI, 10.6-15.5), with a one-year survival rate of 58%. By reducing the dose in serum IL-8 on treatment, prolonged OS was achieved.
Across the different dose groups, the researchers observed no marked dose-dependent differences in either safety or efficacy. The study also revealed that “treatment efficacy was higher in patients with high versus low tumor baseline IL1RAP expression (OS 14.2 vs 10.6 months, P=.026).”
The researchers concluded that better outcomes among study participants correlated with “higher tumor baseline IL1RAP expression,” and that nadunolimab, when combined with GN, can achieve “promising efficacy and manageable safety in locally advanced/metastatic PDAC.”
Source: Clinical Cancer Research
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