NALIRIFOX in Japanese treatment-naïve patients with metastatic pancreatic adenocarcinoma: results from an open-label, phase II study

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.