MM-398 achieves primary endpoint of overall survival in phase III study in patients with gemcitabine refractory metastatic pancreatic cancer.

MM-398 (irinotecan liposome injection), also known as “nal-IRI”, is a nanoliposomal encapsulation of irinotecan, a topoisomerase-I poison. On May 1st, 2014, Merrimack Pharmaceuticals, Inc. (Cambridge, MA, USA) announced that the combination of MM-398 with 5fluorouracil (5-FU) and leucovorin achieved an overall survival of 6.1 months, a 1.9 month improvement over the 4.2 month survival demonstrated by the control arm of 5-FU and leucovorin alone [1]. The primary log-rank analysis of overall survival was statistically significant (P=0.012) with a corresponding hazard ratio of 0.67. A statistically significant advantage for progression free survival was also observed in the combination arm. These results were based on a randomized large phase III study called the NAPOLI-1 study. This study treated patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. The most common Grade >3 toxicities seen were neutropenia (14.5%), fatigue (13.7%), diarrhea (12.8%) and vomiting (11.1%).