by Dr. C.H. Weaver M.D. 6/2023
Onivyde (liposomal irinotecan) was initially FDA approved for treatment of patients with pancreatic cancer that had spread to distant sites in the body who have received prior treatment with the chemotherapy agent, Gemzar® (gemcitabine).1 Clinical trial results presented at the 2023 American Society of Clinical Oncology Annual Meeting show that Onivyde base treatment is actually superior to Gemzar and should now be considered a first line treatment option.2
The pancreas is an organ in the abdomen that resides behind the lower part of the stomach. The pancreas helps aid digestion by releasing certain enzymes. In addition, the pancreas releases hormones, such as insulin, that helps to regulate sugar metabolism. Pancreatic cancer often has no symptoms until it has spread from its site of origin. Once the cancer has spread, particularly if surgical removal is no longer an option, effective treatment options remain limited.
About Onivyde
Onivyde is a novel form of the widely used cancer drug irinotecan. In Onivyde, the irinotecan is bound to albumin, a human protein in tiny particles. This formulation improves the delivery of the drug directly to cancer cells and reduces side effects.
The combination of Onivyde plus 5-fluorouracil/leucovorin (5-FU) and Eloxatin (oxaliplatin) (NALIRIFOX) delays cancer progression and prolongs survival when compared to Gemzar plus Abraxane (nab-paclitaxel) in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma according to data from the phase 3 NAPOLI 3 trial (NCT04083235) presented at the 2023 ASCO Annual Meeting.
“These results support NALIRIFOX as a treatment reference regimen in frontline untreated pancreas cancer,” lead author Eileen M. O’Reilly, MD, Winthrop Rockefeller Endowed Chair of Medical Oncology; co-director of Medical Initiatives at the David M. Rubenstein Center for Pancreatic Cancer Research; and section head of Hepatopancreatobiliary and Neuroendocrine Cancers at Memorial Sloan Kettering Cancer Center, said during a presentation on the findings.”
The NAPOLI 3 clinical trial included a total of 770 patients who were 18 years or older with confirmed advanced pancreatic cancer that was not previously treated in the metastatic setting. The median survival duration in patients treated with NALIRIFOX was 11 months compared to 9 months for those treated with Gemzar and Abraxane. At 18 month 27% of NALIRFOX treated patients survived cancer free – nearly double the rate for Gemzar and Abraxane.
The most commonly reported side effects of treatment with Onivyde were diarrhea, fatigue, vomiting and nausea.
Learn more about the treatment of pancreatic cancer.
References:
- United States Food and Drug Administration. FDA approves new treatment for advanced pancreatic cancer. Available at: . Accessed October 23, 2015.
- O’Reilly EM, Melisi D, Macarulla T, et al. Liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 12- and 18-month survival rates from the phase 3 NAPOLI 3 trial. J Clin Oncol. 2023;41(suppl 16):4006. doi:10.1200/JCO.2023.41.16_suppl.4006
