MM 398 extends survival and PFS in patients with Pancreatic Cancer-Merrimack Pharma

Merrimack Pharmaceuticals has announced detailed results from NAPOLI-1, a large, randomized, three-arm Phase III study of MM 398 (nanoliposomal encapsulated irinotecan), in patients with metastatic Pancreatic Cancer previously treated with gemcitabine-based therapy. The combination of MM 398 with 5-fluorouracil (5-FU) and leucovorin extended overall survival and significantly increased progression free survival (PFS) and overall response rate compared to the control arm of 5-FU and leucovorin alone. Top line results of NAPOLI-1 released in May showed that the combination of MM 398 with 5-FU and leucovorin achieved an overall survival of 6.1 months versus the 4.2 month survival demonstrated by the control arm of 5-FU and leucovorin alone. The primary log-rank analysis of overall survival was statistically significant.

In combination with 5-FU and leucovorin, MM 398 also demonstrated a statistically significant advantage in PFS, with a median of 3.1 months compared to 1.5 months in the control arm. The combination arm also showed a statistically significant difference in overall response rate compared to the control arm (16% and 1%, respectively). The most common non-hematologic grade 3 and higher adverse events in the combination arm were fatigue (14%), diarrhea (13%) and vomiting (11%). Hematologic grade 3 and higher adverse events included neutropenia, which was observed in 20% of patients and febrile neutropenia in 2% of patients. Results were presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer.