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FDA Approval of Irinotecan Liposome for First-Line Pancreatic Cancer
The Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin on February 13, 2024, for treating metastatic pancreatic adenocarcinoma as the initial therapy.
NAPOLI 3 Clinical Trial and Comparative Regimens
NAPOLI 3 (NCT04083235) was a randomized, multicenter, open-label, active-controlled trial with 770 people who had pancreatic adenocarcinoma that had spread to other parts of the body and had never been through chemotherapy in this stage before. It looked at how well the treatment worked. Randomization was categorized based on area, liver metastases, and ECOG performance status. Patients were randomly assigned, in a 1:1 ratio, to receive one of the specified therapies.
NALIRIFOX regimen consists of irinotecan liposome at a dosage of 50 mg/m² administered intravenously over 90 minutes, followed by oxaliplatin at a dosage of 60 mg/m² administered intravenously over 120 minutes, followed by leucovorin at a dosage of 400 mg/m² administered intravenously over 30 minutes, followed by fluorouracil at a dosage of 2400 mg/m² administered intravenously over 46 hours, with this cycle repeated every 2 weeks.
Administer Nab-paclitaxel at a dose of 125 mg/m² intravenously over 35 minutes, followed by gemcitabine at a dose of 1000 mg/m² intravenously over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Significant Survival and Response Outcomes
The primary efficacy measure was overall survival (OS). Other effectiveness criteria were investigator-assessed progression-free survival (PFS) and objective response rate (ORR). NAPOLI 3 showed a substantial increase in overall survival (OS) and progression-free survival (PFS) for the NALIRIFOX group compared to the Gem+NabP group. The median overall survival was 11.1 months (95% CI: 10.0, 12.1) in the NALIRIFOX group and 9.2 months (95% CI: 8.3, 10.6) in the Gem+NabP group. The Hazard Ratio (HR) was 0.84 (95% CI: 0.71, 0.99) with a p-value of 0.0403. The median progression-free survival was 7.4 months (95% CI: 6.0, 7.7) in the NALIRIFOX group and 5.6 months (95% CI: 5.3, 5.8) in the Gem+NabP group (HR 0.70 [95% CI: 0.59, 0.85]; p-value 0.0001). The objective response rate (ORR) was 41.8% (95% CI: 36.8, 46.9) in the NALIRIFOX group and 36.2% (95% CI: 31.4, 41.2) in the Gem+NabP group.
Side Effects and Laboratory Abnormalities
The primary side effects of NALIRIFOX, with a notable difference compared to Gem+NabP, were diarrhea, exhaustion, nausea, vomiting, decreased appetite, gastrointestinal pain, mucosal inflammation, constipation, and decreased weight. The prevalent laboratory abnormalities (≥10% Grade 3 or 4) included reduced neutrophil, potassium, lymphocyte, and hemoglobin levels.
Recommended Dosage and Administration
The suggested dosage of irinotecan liposome is 50 mg/m² given through intravenous infusion lasting 90 minutes every 2 weeks. Administer irinotecan liposome prior to oxaliplatin, fluorouracil, and leucovorin. No specific dosage of irinotecan liposome is advised for patients with blood bilirubin levels beyond the upper limit of normal.
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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