ArticleESMO gastrointestinal oncology2026
NALIRIFOX in Japanese treatment-naïve patients with metastatic pancreatic adenocarcinoma: results from an open-label, phase II study.
Article in ESMO gastrointestinal oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Liposomal irinotecan in combination with oxaliplatin, 5-fluorouracil, and leucovorin (NALIRIFOX) improved survival outcomes of patients with treatment-naïve metastatic pancreatic adenocarcinoma (mPAC) compared with nab-paclitaxel + gemcitabine in the phase III NAPOLI-3 trial. However, no Japanese centre participated in NAPOLI-3. Therefore, this study aims to demonstrate the applicability of the efficacy and safety results of NALIRIFOX observed in the NAPOLI-3 trial to a Japanese population. Materials and methods: In this ongoing, phase II study, patients with treatment-naïve mPAC received NALIRIFOX across 15 Japanese centres. Eligible patients had ≥1 measurable metastatic lesion, an Eastern Cooperative Oncology Group performance status of 0-1, and an initial mPAC diagnosis ≤6 weeks before screening. The primary endpoint was objective response (OR) per independent central review (ICR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and quality of life (QoL). Results: Forty-one Japanese patients received NALIRIFOX, and the median follow-up duration was 12.8 months. Seventeen (41.5%) patients had an OR and the DCR was 61.0% per ICR. Median OS was 9.9 months [95% confidence interval (CI) 7.4-12.9]; 6-month OS rate was 73.2%. Median PFS per ICR was 4.4 months (95% CI 2.3-7.2). Treatment-emergent adverse events (TEAEs) occurred in 97.6% of patients and the most frequent serious TEAEs were decreased appetite (22.0%) and decreased neutrophil count (17.1%). QoL global health status was maintained throughout the study. Conclusion: The efficacy and safety of NALIRIFOX for first-line treatment of mPAC in this Japanese population is consistent with results of NAPOLI-3.
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