May 2, 2014
PharmaEngine, Inc. announced today in conjunction with Merrimack Pharmaceuticals, Inc. that the top line data of the global, open label, three arm randomized phase 3 metastatic pancreatic cancer (NAPOLI-1) study showed that the combination arm of MM-398 (irinotecan liposome injection) with 5-fluorouracil/leucovorin (5-FU/LV) achieved the primary endpoint of overall survival. Median overall survival on the combination arm was 6.1 months as compared to 4.2 months for the control arm of 5-FU/LV. The hazard ratio for overall survival, the trial’s primary endpoint, was 0.67, which was statistically significant with a p-value of 0.012. A statistically significant difference in progression-free survival was also observed, and the safety profile of the combination arm was manageable.
On the contrary, the monotherapy arm of MM-398 did not meet the primary endpoint as compared to the control arm of 5-FU/LV (4.9 months vs. 4.2 months, p-value = 0.942, hazard ratio = 0.99), and the patients in this monotherapy arm displayed higher levels of adverse events than those in the combination arm.
“NAPOLI-1 study is the first phase 3 registration trial successfully demonstrating survival benefits of the MM-398/5-FU/LV combination in the metastatic pancreatic cancer patients in the post-gemcitabine setting. It has been my privilege to have contributed since the beginning of the clinical development of this drug in Taiwan, which I hope, offers clinically meaningful benefits to this devastating patient population around the globe,” said Prof. Li-Tzong Chen, Director of National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
“My sincere gratitude goes to Prof. Aimery de Gramont, Hôpital Saint-Antoine, Paris, France who proposed this combination regimen (known as FUPEP regimen) and provided its initial safety data in a phase 2 metastatic colorectal cancer study which allowed us adding this arm to the NAPOLI-1 study. We are grateful to so many patients, their physicians, and caregivers who were willing to partake in this important study,” said C. Grace Yeh, Ph.D., President and CEO of PharmaEngine. “We are delighted to collaborate effectively with Merrimack in completing the study in such an expeditious manner, and plan to submit a New Drug Application to Taiwan FDA before the end of this year. The successful development of this drug has opened a new page for the pharmaceutical industry in Taiwan.”
An abstract for this study has been accepted for oral presentation by the global principal investigator, Dr. Daniel D. Von Hoff, Chief Scientific Officer for Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief for the Translational Genomics Research Institute (TGen), at the European Society for Medical Oncology World Conference on Gastrointestinal Cancer to be held on June 25-28, 2014 in Barcelona, Spain.
About NAPOLI-1 Study
The global, randomized, open label phase 3 study, referred to as NAPOLI-1 (NAPOLI acronym: NAnoliPOsomaL Irinotecan), is being sponsored by Merrimack Pharmaceuticals, Inc. (Cambridge, MA, USA). Patients were recruited from over 100 sites in 15 countries (North America, South America, Europe, Asia and Australia). The total enrollment of 417 patients were randomized across the three arms: MM-398 (120 mg/m2, every three weeks) as a monotherapy, MM-398 (80 mg/m2, every two weeks) in combination with 5-FU/LV, and a shared control arm of 5-FU/LV. The primary endpoint of this study is overall survival. For study details, please see www.clinicaltrials.gov.
About MM-398 (aka PEP02)
MM-398 (irinotecan liposome injection), also known as “nal-IRI”, is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. In May 2011, PharmaEngine granted back to Merrimack the rights to develop, manufacture, and commercialize MM-398 in Asia and Europe, and retained its rights to the product in Taiwan, where it is known as PEP02. MM-398 has received orphan drug designation from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in metastatic pancreatic cancer during the same year.
About Pancreatic Cancer
Metastatic pancreatic cancer is almost uniformly fatal, with an overall survival rate of approximately 5 percent at 5 years worldwide. The first-line therapy approved for the metastatic pancreatic cancer is gemcitabine or gemcitabine-containing regimen. However, the treatment effect of gemcitabine is limited in terms of extending the survival period and improving the quality of life. The patients with metastatic pancreatic cancer, who failed gemcitabine treatment, have no standard therapy approved by any regulatory authority.
About PharmaEngine, Inc. (TWO: 4162)
PharmaEngine, Inc. is a biopharmaceutical company established in Taipei, Taiwan in 2003. PharmaEngine focuses on the development of new drugs for the treatment of cancer and Asian prevalent diseases. PharmaEngine has two clinical stage projects and one in drug discovery stage. For further information, please visit the PharmaEngine’s website at http://www.pharmaengine.com.