Today at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium, data were presented from the phase III “NAPOLI 3” trial, evaluating Onivyde® (irinotecan liposome injection) plus 5 fluorouracil (5-FU)/leucovorin and oxaliplatin (NALIRIFOX regimen) in patients with previously untreated metastatic pancreatic cancer.
The NALIRIFOX regimen was compared to nab-paclitaxel (Abraxane®) plus gemcitabine (Gemzar®), which is one of the current standard-of-care treatments for patients with metastatic pancreatic cancer. The clinical trial results showed that patients treated with NALIRIFOX had an overall survival of 11.1 months, which was a statistically significant improvement over the 9.2-month overall survival with Gemzar and Abraxane.
“We are encouraged to see these results from the NAPOLI 3 clinical trial, and we are grateful to the company Ipsen for evaluating their investigational drug in this hard-to-treat cancer type,” said Sudheer Doss, PhD, PanCAN’s Chief Business Officer. “We are also thankful for the patients who participated in this research study in order to determine that this treatment regimen holds promise for patients diagnosed with metastatic pancreatic cancer today and in the future.”
PanCAN strongly recommends clinical trials at diagnosis and during every treatment decision – and the PanCAN Patient Services team can help patients, caregivers and healthcare professionals conduct a personalized clinical trials search. During January, Pancreatic Cancer Clinical Trials Awareness Month, PanCAN is bringing special attention to this important treatment option.
Onivyde was previously approved in 2015 for patients with metastatic pancreatic cancer whose disease had progressed following treatment with Gemzar. Following the positive clinical trial results presented today, Ipsen will request that the U.S. Food & Drug Administration (FDA) add another indication to the drug and allow it to be used in patients with untreated metastatic pancreatic cancer.
“The only way to bring new treatment options to patients is through lab-based research and clinical trials,” Doss said. “PanCAN remains committed to providing evidence-based information and resources to patients and caregivers and advancing research to improve patient outcomes.”