Final phase III results with Onivyde (irinotecan) in combination with fluorouracil and leucovorin shows efficacy is maintained in pancreatic ductal adenocarcinoma - Merrimack Pharma

Merrimack Pharmaceuticals announced final results from the pivotal Phase III NAPOLI-1 study validating the use of Onivyde (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin, which represents a new standard of care for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) following treatment with gemcitabine-based therapy. In this extended analysis of NAPOLI-1, the previously described overall survival advantage was maintained for Onivyde in combination with 5-FU and leucovorin versus 5-FU and leucovorin alone: 6.2 months versus 4.2 months. Findings also showed that one in four patients treated with the Onivyde combination regimen survived one year or more, a significant milestone. This was represented by a 26% probability of survival at one year for patients receiving Onivyde in combination with 5-FU and leucovorin versus 16% for patients who received 5-FU and leucovorin alone.

Furthermore, disease control was achieved in twice as many patients treated with Onivyde in combination with 5-FU and leucovorin (52%) compared to 5-FU and leucovorin alone (24%). The demonstrated improvements in overall survival for the Onivyde combination regimen were achieved with little or no impact on quality of life over 12 weeks despite the addition of a second chemotherapeutic agent to 5-FU and leucovorin, a therapy recognized as a well-managed treatment for metastatic pancreatic cancer.

Results from a separate analysis of the NAPOLI-1 data evaluating the incidence and prevalence of gastrointestinal toxicities and neutropenia during the course of treatment with Onivyde plus 5-FU and leucovorin showed that the majority of these adverse events occurred early in treatment with decreased incidence and severity thereafter. Dose reductions or dose delays were commonly used to manage these adverse events and may account for the decreased incidence and/or severity that was observed. The final NAPOLI-1 results were presented at the European Society for Medical Oncology 2016 Congress.