Merrimack Pharmaceuticals, Inc. (MACK - Free Report) announced encouraging final data from a phase III study, NAPOLI-1, on Onivyde, in combination with fluorouracil (5-FU) and leucovorin, in the treatment of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC), following treatment with Eli Lilly and Company’s (LLY - Free Report) Gemzar (gemcitabine)-based therapy.
Data from the study demonstrated a high level of clinical evidence, thereby validating the use of Onivyde as a meaningful treatment option for metastatic pancreatic cancer.
Results confirmed overall survival and progression-free survival benefit of the Onivyde regimen. The disease control rate was found to be almost double in patients treated with Onivyde, in combination with 5-FU and leucovorin, compared to 5-FU and leucovorin alone. Results were presented at the congress of the European Society for Medical Oncology.
We note that in Oct 2015, Onivyde was approved in the U.S. for use in combination with fluorouracil (5-FU) and leucovorin for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following Gemzar-based therapy. However, Onivyde’s label contains a black box warning regarding severe neutropenia and diarrhea.
Onivyde is currently under review in the EU. In Jul 2016, Merrimack received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
In the U.S., the combination was added to the National Comprehensive Cancer Network (NCCN) 2016 clinical practice guidelines in oncology as a category I treatment option for patients with pancreatic adenocarcinoma. Meanwhile, it was given a category 2B status in the European Society for Medical Oncology (ESMO) 2015 clinical practice guidelines.
We remind investors that Merrimack has an exclusive licensing agreement with Shire plc (SHPG - Free Report) for the development and commercialization of Onivyde outside the U.S. and Taiwan.
According to the American Cancer Society, approximately 50,000 patients are diagnosed with pancreatic cancer each year in the U.S. Moreover, the World Health Organization estimates that approximately 338,000 new cases of pancreatic cancer occur each year in the world.
Currently, Merrimack is working on expanding Onivyde’s label to include metastatic colorectal cancer, pediatric solid tumors and glioma, among others.
The company currently carries a Zacks Rank #3 (Hold).
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