The US Food and Drug Administration (FDA) has approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) in combination with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreatic adenocarcinoma. The approval was based on findings from the randomized, controlled, open-label NAPOLI3 trial, which evaluated the combination, known as NALIRIFOX, vs gemcitabine plus nab-paclitaxel in patients who had not previously received chemotherapy in the metastatic setting. The National Comprehensive Cancer Network also upgraded the regimen as the preferred first-line treatment for metastatic pancreatic adenocarcinoma as well as for locally advanced disease. clinicaltrials.gov/study/NCT04083235 In the trial, 770 patients were randomized 1:1 to receive NALIRIFOX or gemcitabine plus nab-paclitaxel, a current standard of care in this setting. Patients receiving NALIRIFOX demonstrated significant improvements in median overall survival and progression-free survival (PFS) - with a median overall survival of 11.1 months vs 9.2 months in the gemcitabine plus nab-paclitaxel arm (hazard ratio [HR], 0.84) and a median PFS of 7.4 months vs 5.6 months (HR, 0.70). The overall response rate was also higher in the NALIRIFOX arm - 41.8% vs 36.2%. The recommended irinotecan liposome dose is 50 mg/m2 administered by intravenous infusion over 90 minutes every 2 weeks, before oxaliplatin, fluorouracil, and leucovorin. There is no recommended irinotecan liposome dose for patients with serum bilirubin above the upper limit of normal. The label for irinotecan liposome comes with a boxed warning, noting a risk for severe or life-threatening neutropenia and diarrhea.
Hi Dr. Kim, just wanted to thank you for these short videos. I'm a medical oncology resident prepping for my exam in a few weeks. These videos provide a great summary for me and helps me know where to dive into more details on. Really appreciate it, wishing you all the best!
