Onivyde regimen demonstrated statistically significant improvement in overall survival
Ipsen has announced that the phase 3 NAPOLI 3 trial of Onivyde – a irinotecan liposome injection plus 5 fluorouracil/leucovorin and oxaliplatin – has successfully met its primary endpoint.
The therapy demonstrated clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
It also reached the key secondary efficacy outcome of progression-free survival, while the safety profile of Onivyde in the NAPOLI 3 trial was consistent with those observed in the previous phase 1/2 mPDAC study.
mPDAC is the most common cancer that forms in the pancreas with approximately 60,000 people diagnosed in the US each year and nearly 500,000 people globally. Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body.
“The positive results from the NAPOLI 3 trial demonstrate that compared with the standard of care, the investigational Onivyde treatment regimen extended the lives of people living with metastatic pancreatic ductal adenocarcinoma who were previously untreated,” reflected Howard Mayer, executive vice president and head of research and development, Ipsen.
He added: “The prognosis for people diagnosed with pancreatic cancer is extremely poor and we plan to submit these new findings to the regulatory authority as, if approved, we believe this regimen could offer up an important new treatment option for people living with an aggressive and hard-to-treat cancer. We thank the patients who participated in the study, their families and their healthcare teams.”
Ipsen intends to file a supplemental New Drug Application with the US Food and Drug Administration for Onivyde following the Fast Track Designation granted in 2020.