Merrimack Pharma (MACK) Announces Final Phase 3 NAPOLI-1 Study Results; Previous OS Advantage Maintained

October 11, 2016 7:44 AM EDT
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Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) announced 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, 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, M.D., Ph.D., 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 the intention-to-treat (ITT) population. 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 (p=0.039, hazard ratio (HR) =0.75, 95% CI: [.057 - .99]). 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 primary Phase 3 NAPOLI-1 data were the basis of the US Food and Drug Administration (FDA) and Taiwan FDA approvals of the ONIVYDE® (irinotecan liposome injection) combination regimen in October 2015. They were also the basis of the European Union's Committee for Medicinal Products for Human Use (CHMP) positive opinion issued in July 2016. The ONIVYDE combination is designated as a category 1 treatment option in the 2016 National Comprehensive Cancer Network (NCCN) guidelines for pancreatic adenocarcinoma in the United States as well as a category 2B status in the 2015 European Society for Medical Oncology (ESMO) clinical practice guidelines in the European Union.

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