PharmaEngine Announces the Lancet Publication of the ONIVYDE Phase 3 NAPOLI-1 Study

PharmaEngine announced that The Lancet has published the manuscript entitled "Nanoliposomal irinotecan with fluorouracil and leucovorin in metastatic pancreatic cancer after prior gemcitabine-based therapy (NAPOLI-1): a global, randomized, open-label phase 3 trial" online in advance of its print issue. The Lancet is one of the most prestigious and best known journals in the medical field. The NAPOLI-1 study results showed that ONIVYDE™ (also known as PEP02, MM-398, nal-IRI) in combination with fluorouracil (5-FU) and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy demonstrated a clinically and statistically significant improvement in overall survival. ONIVYDE was granted regulatory approvals by the Taiwan FDA and the U.S. FDA on October 22, 2015. "NAPOLI-1 study is the first phase 3 registration trial successfully demonstrating survival benefits of the ONIVYDE/5-FU/LV combination in the metastatic pancreatic cancer patients in the post-gemcitabine setting. I am delighted and privileged to have participated in the entire clinical development of ONIVYDE. I hope that ONIVYDE can offer clinically meaningful benefits to patients facing this devastating disease in the near future," said Prof. Li-Tzong Chen, Director of National Institute of Cancer Research, National Health