PharmaEngine says positive Phase III results achieved with pancreatic cancer candidate MM-398

20 January 2015

Taiwan's PharmaEngine (TWO: 4162) says that the additional analyses from the global Phase III NAPOLI-1 study of MM-398 (PEP02, liposome irinotecan injection) in metastatic pancreatic cancer were presented at the American Society of Clinical Oncology 2015 Gastrointestinal Cancers Symposium (ASCO GI) confirming earlier positive findings.

This Phase III NAPOLI-1 study was sponsored by PharmaEngine’s partner, Merrimack Pharmaceuticals (Nasdaq: MACK). PharmaEngine retains the rights to commercialize MM-398 in Taiwan.

The primary analysis of the NAPOLI-1 Phase II trial, presented at ESMO GI 2014 in Barcelona, Spain last year, demonstrated a statistically-significant increase in overall survival with an unstratified hazard ratio of 0.67 (95% CI [0.49-0.92], p = 0.0122) and a median of 6.1 months for the combination of MM-398 plus 5-FU/LV compared to 4.2 months in the 5-FU/LV control arm.

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