Updated survival data for Onivyde (irinotecan liposome injection) in pancreatic cancer- Merrimack Pharmaceuticals

Merrimack Pharmaceuticals has announced that an updated overall survival analysis of the Phase III NAPOLI-1 study of Onivyde (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin achieved a substantial improvement in 12-month overall survival in patients with post-gemcitabine metastatic pancreatic adenocarcinoma when compared to 5-FU and leucovorin alone. Analysis of the updated data supports the robustness of the overall survival benefit of the Onivyde combination therapy observed in the primary analysis of the NAPOLI-1 trial. Updated findings showed one in four patients treated with Onivyde survived a milestone of one year or more: 12-month overall survival estimates of 26% for Onivyde in combination with 5-FU and leucovorin, a 63% improvement when compared to 16% for 5-FU and leucovorin alone. No new safety or tolerability concerns were note in the updated analysis.

Primary survival analysis was based on 313 events and showed that Onivyde in combination with 5-FU and leucovorin significantly improved 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. These updated data will be presented at the American Society of Clinical Oncology 2016 Gastrointestinal Cancers Symposium.