Recently, the U.S. FDA approved a new pancreatic cancer** regimen that combines Ipsen's onivyde with chemotherapy for first-line*** metastatic tumors.
The protocol is abbreviated as Nalirifox, i.e., Onivyde (irinotecan liposomal injection) in combination with oxaliplatin, fluorouracil and leucovorin. This is the second time that the ONIVYDE regimen has been approved for metastatic pancreatic cancer, following FDA's approval of Onivyde in combination with fluorouracil and leucovorin** gemcitabine** disease progression in 2015.
The anticancer agent in onivyde is a widely used chemotherapy drug called irinotecan. The drug works by blocking topoisomerase I, a key enzyme for cancer cell replication. Onivyde's innovation is to encapsulate irinotecan in tiny fat particles called liposomes. The purpose of these particles is to reduce the leakage of the drug payload before it reaches the tumor. Paris-based Ipsen says liposomes build up at tumor sites, slowly releasing drugs over time.
The approval was based on results from the NAPOLI Phase 33 trial (NCT04083235). The trial included 770 patients with metastatic pancreatic adenocarcinoma who had not received prior treatment in the metastatic setting**.
Patients were randomly assigned to receive either nalirifox regimen** every two weeks** or nab-paclitaxel and gemcitabine** on the first day of each 28-day cycle.
Nalirifox improved response rates, progression-free survival (PFS), and overall survival (OS).
The median OS in the Nalirifox group was 11At 1 month, the median OS for the nab-paclitaxel and gemcitabine groups was 92 months (hazard ratio [hr], 0..)84；95%ci，0.71-0.99；p=0.0403）。The median PFS was 7., respectively4 months and 56 months (hr, 0..)70；95%ci，0.59-0.85；p=0.0001）。The objective response rate was 418% and 362%。
Adverse events that were more common in the Nalirifox group than in the nab-paclitaxel and gemcitabine groups (5% between groups for any grade of AE and 2% for grade 3 to 4 AE) included diarrhoea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and weight loss.
Reference**: Ipsen's onivyde regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA', press release. ipsen；Released on February 13, 2024.
Note: The purpose of this article is to introduce medical and health research, and does not make any basis for medication.