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NALIRIFOX Regimen ‘New Possible Standard of Care’ for Some With Pancreatic Cancer

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Results from the phase 3 NAPOLI trial show survival benefits for patients with metastatic pancreatic ductal adenocarcinoma treated with Onivyde plus oxaliplatin, leucovorin and fluorouracil.

image of pancreatic cancer

Patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with the NALIRIFOX regimen of Onivyde (irinotecan liposome injection) plus oxaliplatin, leucovorin and fluorouracil experienced survival benefits when compared to patients treated with nab-paclitaxel and gemcitabine, according to recently published trial findings.

“The findings of this study support the use of the NALIRIFOX regimen as a new possible standard of care and reference regimen for the first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma,” researchers wrote in a study published in The Lancet, noting that to their knowledge NAPOLI 3 is “the first phase 3 trial, performed in community and academic centers worldwide, to compare two combination chemotherapy regimens head-to-head in patients with pancreatic ductal adenocarcinoma who have not previously received treatment for metastatic disease.”

Under NAPOLI 3, 770 patients with mPDAC were randomly assigned to receive NALIRIFOX (383 patients) or nab-paclitaxel and gemcitabine (387 patients). At a median follow-up of 16.1 months, the median overall survival (the time following treatment that a patient is still alive) was 11.1 and 9.2 months, respectively, with grade 3 or higher side effects occurring in 87% and 86% of participants and treatment-related deaths occurring in six and eight patients, respectively, researchers reported.

Nearly all participants — 369 of 370 on the NALIRIFOX arm and 376 of 379 in the nab-paclitaxel and gemcitabine arm — experienced side effects, with the most common grade 3 or 4 side effects being neutropenia (a low count of neutrophils, a type of white blood cell), diarrhea and hypokalemia (low potassium) in the former and neutropenia, anemia (low red blood cells) and peripheral neuropathy (pain, tingling or numbness in the hands or feet) in the latter.

Median progression-free survival (the time following treatment that a patient lives without the disease spreading or worsening) was 7.4 months for patients in the NALIRIFOX group and 5.6 months for patients in the nab-paclitaxel and gemcitabine group, according to the authors, who also stated that 160 (42%) of patients in the NALIRIFOX group responded to treatment, compared to 140 (36%) of patients in the nab-paclitaxel and gemcitabine group, with the median durations of response being 7.3 and 5 months, respectively.

Ipsen, the biopharmaceutical company behind Onivyde, announced this summer that the Food and Drug Administration (FDA) had accepted a supplemental new drug application for the NALIRIFOX regimen as a potential first-line treatment for patient with mPDAC, with the agency setting a Prescription Drug User Fee Act goal date of Feb. 13, 2024 for its review. The FDA had previously granted Fast Track designation for Onivyde as a first-line combination treatment for patients with mPDAC in 2020.

Accounting for 3% of all cancers and 7% of all cancer deaths in the United States, there will be an estimated 64,050 new cases of pancreatic cancer and approximately 50,5500 deaths from pancreatic cancer in 2023, according to the American Cancer Society.

Approximately 93% of pancreatic cancers are exocrine tumors, which start in the exocrine cells of the pancreas, with the most common type being pancreatic ductal adenocarcinoma, according to a study published in Genes which described pancreatic ductal adenocarcinoma as “a highly aggressive malignancy with limited treatment options and a dismal prognosis” representing the fourth leading cause of cancer death and the twelfth most common cancer globally, with metastatic disease having a 3% five-year survival rate.

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