The FDA has recently approved NALIRIFOX for the frontline treatment of patients with metastatic pancreatic adenocarcinoma, based on the results of the phase 3 NAPOLI 3 trial. This trial demonstrated that NALIRIFOX, a combination of irinotecan liposome (Onivyde), oxaliplatin, 5-fluorouracil, and leucovorin, had a median overall survival (OS) of 11.1 months compared to 9.2 months with gemcitabine plus nab-paclitaxel. Additionally, NALIRIFOX showed a longer progression-free survival (PFS) and a higher overall response rate (ORR) compared to the control regimen.
According to Dr. Dae Won Kim from the Moffitt Cancer Center, current first-line treatment options for metastatic pancreatic cancer include gemcitabine with or without nab-paclitaxel, FOLFIRINOX, and NALIRIFOX. The NAPOLI 3 trial findings suggest that NALIRIFOX may be a more effective treatment option than gemcitabine plus nab-paclitaxel, especially for patients with a good Eastern Cooperative Oncology Group (ECOG) performance status. However, direct comparisons between NALIRIFOX and FOLFIRINOX have not been conducted yet.
While more research is needed to determine the best treatment regimen for patients with metastatic pancreatic cancer, the NAPOLI 3 data support the use of NALIRIFOX as a promising option for those with a good ECOG performance status. This approval marks a significant advancement in the treatment of this challenging disease.