Source: Ipsen Pharma
The FDA has accepted a supplemental new drug application (sNDA) for the combination of liposomal irinotecan, 5-fluorouracil, leucovorin, and oxaliplatin (NALIRIFOX) as a first-line treatment option for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). This decision follows the promising results from the Phase III NAPOLI 3 trial (NCT04083235), which demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) compared to the standard treatment of nab-paclitaxel plus gemcitabine.
The NAPOLI 3 trial included previously untreated patients with confirmed metastatic PDAC. Patients receiving NALIRIFOX showed a median OS of 11.1 months, while those on nab-paclitaxel and gemcitabine had a median OS of 9.2 months. The median PFS was 7.4 months for NALIRIFOX-treated patients compared to 5.6 months for the other group. These findings support the efficacy of NALIRIFOX as a first-line therapy for metastatic PDAC.
The FDA has set a Prescription Drug User Fee Act action date of February 13, 2024, based on the data presented. This indicates that a decision regarding the approval of NALIRIFOX for this indication will be made by that date.
The NAPOLI 3 trial was an open-label, multicenter Phase III study that enrolled patients with recently diagnosed metastatic PDAC. Patients were assigned randomly to receive either NALIRIFOX or nab-paclitaxel plus gemcitabine. The primary endpoint was OS, while secondary endpoints included PFS, overall response rate, and safety. The study also evaluated other factors such as quality of life and biomarker assessments.
Additional data from the trial demonstrated that patients treated with NALIRIFOX had an overall response rate of 41.8%, including a complete response rate of 0.3% and a partial response rate of 41.5%. The safety profile of NALIRIFOX was consistent with the known side effects of its individual components, with diarrhea, nausea, hypokalemia, anemia, and neutropenia being the most common grade 3/4 adverse events.
The acceptance of the sNDA for NALIRIFOX as a first-line treatment for metastatic PDAC offers new hope for patients with this challenging disease. If approved, it could provide an effective and well-tolerated therapeutic option that improves overall survival and progression-free survival compared to the current standard treatment.
