The phase 3 NAPOLI-3 trial showed that liposomal irinotecan plus 5-fluorouracil/leucovorin and oxaliplatin (NALIRIFOX) outperformed nab-paclitaxel plus gemcitabine in patients with untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).
The phase 3 NAPOLI-3 trial compared nab-paclitaxel plus gemcitabine with NALIRIFOX for the first-line treatment of 770 patients with mPDAC.1 Eligible patients were randomized 1:1 to evaluate the primary endpoint of overall survival (OS). Prof. Zev Wainberg (UCLA) presented the late-breaking results at ASCO-GI 2023.
After a median follow-up of 16.1 months, the OS was significantly improved in the NALIRIFOX arm compared with the control arm (median OS, 11.1 months vs 9.2). Similarly, progression-free survival (PFS) was improved in patients receiving NALIRIFOX compared with those receiving nab-paclitaxel plus gemcitabine (median PFS, 7.4 months vs 5.6).
Prof. Wainberg mentioned that NALIRIFOX had a manageable safety profile, consistent with the toxicity profiles of the individual treatment components. Comparable rates of grade 3 or higher adverse events (AEs) were reported for the two study groups (87.0% and 86.0%). However, grade 3 or 4 hematologic AEs were more common among patients receiving nab-paclitaxel plus gemcitabine, whereas those who were exposed to NALIRIFOX showed higher rates of grade 3 or 4 diarrhea (20.3% vs 4.5%), nausea (11.9% vs 2.6%), and vomiting (7.0% vs 2.1%).
Prof. Wainberg concluded that these results support the administration of NALIRIFOX as first-line therapy for patients with mPDAC.
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