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Frontline Irinotecan Liposome OKed in Mets Pancreatic Cancer
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.
"We are pleased that the FDA has approved the NALIRIFOX regimen," Julie Fleshman, president and chief executive officer of the patient advocacy group Pancreatic Cancer Action Network, said in a press statement. "For a tough disease with few treatment options, this is significant news for people with metastatic pancreatic ductal adenocarcinoma (PDAC), given it has been more than 10 years since there has been a PDAC-specific approval in the first-line setting."
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.
Common adverse reactions occurring more often in patients who received NALIRIFOX include diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight. The most common laboratory abnormalities were decreased neutrophils, decreased potassium, decreased lymphocyte, and decreased hemoglobin.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X (formerly known as Twitter) @SW_MedReporter.
