Phase III results with Onivyde (irinotecan liposome injection) in Pancreatic cancer published in The Lancet- Merrimack/Baxalta

Merrimack and Baxalta have announced that The Lancet has published results of the NAPOLI-1: a global, randomised, open-label, phase III trial of Onivyde (irinotecan liposome injection) in Pancreatic cancer, have been published in The lancet in advance of its print issue. The NAPOLI-1 study results were the basis of the recent FDA and Taiwan FDA approval of Onivyde 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. The Onivyde combination regimen demonstrated a significant increase in median overall survival versus 5-FU and leucovorin alone: 6.1 months vs 4.2 months.

The monotherapy regimen in this study did not show improvement over the 5-FU and leucovorin arm: 4.9 vs 4.2 months. Onivyde in combination with 5-FU and leucovorin achieved a longer progression-free survival compared with the 5-FU and leucovorin arm (3.1 months versus 1.5 months. Unconfirmed objective response rate was higher in the Onivyde in combination with 5-FU and leucovorin arm than in the 5-FU and leucovorin arm: 16% (19/117) versus 1% (1/119). The most common grade 3 or 4 adverse events that occurred more frequently in the Onivyde in combination with 5-FU and leucovorin arm (>2% incidence versus 5-FU and leucovorin) were neutropenia, diarrhea, vomiting, and fatigue.