Merrimack Pharmaceuticals Inc. (NASDAQ: MACK) shares saw a handy gain early Tuesday after the company announced positive results for its late stage metastatic pancreatic cancer study at the European Society for Medical Oncology (ESMO).
Specifically, the company 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.
Findings from the study showed that one in four patients treated with the Onivyde combination regimen survived one year or more, which is 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.
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.
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.
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, commented:
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. 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.
Excluding Tuesday’s move, Merrimack has underperformed the broad markets, with the stock down 28% year to date. Over the past 52 weeks, the stock is actually down 41%.
Shares of Merrimack closed Monday up 3.3% at $5.66, with a consensus analyst price target of $11.67 and a 52-week trading range of $4.39 to $10.85. Following the announcement, the stock was last seen up about 8% at $6.11 in early trading indications.