Phase III NAPOLI-1 data shows patients treated with Onivyde (irinotecan liposome injection) have similar quality of life compared to other treatment regimes in pancreatic cancer- Merrimack Pharmaceuticals

Merrimack Pharmaceuticals has announced a newly presented analysis of the Phase III NAPOLI-1 data shows patients with metastatic Pancreatic Cancer treated with Onivyde (irinotecan liposome injection), also known as "nal-IRI," in combination with fluorouracil (5-FU) and leucovorin, maintain similar baseline quality of life at 12 weeks despite the addition of a second chemotherapeutic agent when compared to 5-FU and leucovorin alone. No substantial differences are identified in the percentage of patients exhibiting improved, stable or worsening quality of life in the global health status, functional scale or symptom scale scores between the two study arms.

The analysis demonstrates that in the NAPOLI-1 study, evaluable patients treated with the Onivyde combination regimen were able to maintain quality of life over 12 weeks and there were no significant differences versus the 5-FU and leucovorin-treated patients in quality of life response despite the addition of a second chemotherapeutic agent. These findings were presented at the European Society for Medical Oncology (ESMO) 18th World Congress on Gastrointestinal Cancer.

Comment: Previously reported Phase III NAPOLI-1 data demonstrate that the Onivyde combination regimen significantly improves overall survival and progression-free survival when compared to 5-FU and leucovorin alone. Onivyde in combination with 5-FU and leucovorin was approved by the FDA in October 2015 for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease progressed after gemcitabine-based therapy. It is the first and only FDA-approved therapy in this setting and was recently designated category 1 status by the National Comprehensive Cancer Network.