FDA approves Onivyde as first-line treatment for metastatic pancreatic cancer
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The FDA approved irinotecan liposome as part of a first-line regimen for the treatment of metastatic pancreatic adenocarcinoma.
Irinotecan liposome (Onivyde, Ipsen) is a topoisomerase inhibitor designed to be given as an IV injection and as part of a regimen — also known as NALIRIFOX — comprising the chemotherapy drugs oxaliplatin, fluorouracil, and leucovorin. The regimen previously received orphan drug designation from the FDA.
The regulator approved the irinotecan liposome-led regimen based on results from the phase 3 NAPOLI-3 trial. The multicenter study evaluated the safety and efficacy of the regimen compared with the current standard-care treatment in adults with metastatic pancreatic adenocarcinoma who had not previously received chemotherapy for metastatic disease.
The open-label study included 770 patients randomly assigned in a 1:1 ratio to receive NALIRIFOX or nab-paclitaxel plus gemcitabine. OS served as the study’s main efficacy outcome measurement, with investigator-assessed PFS and objective response rate as secondary outcomes.
Results from the study showed a significant improvement in median OS in the NALIRIFOX arm compared with nab-paclitaxel plus gemcitabine (11.1 vs. 9.2 months; HR = 0.84; 95% CI, 0.71-0.99). Study findings also revealed significantly longer median PFS for the NALIRIFOX group vs. those who received nab-paclitaxel (7.4 vs. 5.6 months; HR = 0.70; 95% CI, 0.59-0.85).
The most frequently reported treatment-related adverse events associated with the NALIRIFOX included diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation and decreased weight. The most common grade 3 or grade 4 hematologic toxicities associated with NALIRIFOX included decreased neutrophils, potassium, lymphocytes and hemoglobin.
"This new treatment regimen for metastatic pancreatic cancer marks a significant milestone for patients," Paul Oberstein, MD, medical oncologist at NYU Langone Perlmutter Cancer Center, told Healio. "It is the first new approval for first-line [treatment] in many years. ... It is an exciting new addition to our tools to fight pancreatic cancer and improve patient outcomes."
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