NAPOLI-1 Phase 3 study confirms benefit for ONIVYDE regimen for pancreatic cancer

11th October 2016 (Last Updated October 11th, 2016 18:30)

Merrimack Pharmaceuticals has announced the final results from the pivotal Phase 3 NAPOLI-1 study validating the use of ONIVYDE (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin to treat metastatic pancreatic cancer.

Merrimack Pharmaceuticals has announced the final results from the pivotal Phase 3 NAPOLI-1 study validating the use of ONIVYDE (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin to treat metastatic pancreatic cancer.

This represents a new standard of care for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) following treatment with gemcitabine-based therapy.

Taiwan-based National Health Research Institutes' National Institute of Cancer Research director and NAPOLI-1 trial investigator Prof. Li-Tzong Chen said: "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.

"The ONIVYDE regimen provides an opportunity for extended overall survival while maintaining baseline quality-of-life."

"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."

Findings indicated that one in four patients treated with the ONIVYDE combination regimen survived one year or more, which is a major 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%).

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.

Results from another analysis of the NAPOLI-1 data analysing the incidence and prevalence of gastrointestinal toxicities and neutropenia during the course of treatment with ONIVYDE plus 5-FU and leucovorin indicated that the majority of these adverse events occurred early in treatment with decreased incidence and severity thereafter.

Dose reductions or dose delays were used to manage these adverse events.

Pancreatic cancer is deadly disease with only 7% of all patients surviving five years or longer.

There are approximately 50,000 patients diagnosed with pancreatic cancer each year in the US, and sigificant majority has adenocarcinoma.