publication date: Oct. 20, 2016

Pancreatic Cancer ONIVYDE Regimen Produced OS, PFS Benefit In Metastatic Disease

Merrimack Pharmaceuticals Inc. 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.

The final NAPOLI-1 results were presented in a poster discussion session and a separate analysis of NAPOLI-1 safety-over-time data was presented in a poster session at the European Society for Medical Oncology 2016 Congress in Copenhagen.

“The final results of the NAPOLI-1 study provide a high level of clinical evidence establishing the ONIVYDE regimen as a meaningful treatment option for patients with metastatic pancreatic cancer,” said Prof. Li-Tzong Chen, corresponding author, investigator on the NAPOLI-1 trial and director, National Institute of Cancer Research, National Health Research Institutes in Tainan, Taiwan. “Pancreatic cancer is a devastating disease with a poor prognosis. In a patient population with few treatment options, the ONIVYDE regimen provides an opportunity for extended overall survival while maintaining baseline quality-of-life and represents a new standard of care. We thank all of the patients, caregivers and investigators who participated in this pivotal study.”

The extended data cutoff occurred at final database lock in November 2015 after 382 OS events that had occurred in … Continue reading CCL Oct 2016 – ONIVYDE Regimen Produced OS, PFS Benefit In Metastatic Disease

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