Phase II Study of MM 398 in Pancreatic Cancer published
Results from a Phase II study of PEP02, also known as MM 398 (nanoliposomal irinotecan), from Merrimack Pharmaceuticals, as second-line treatment for Pancreatic Cancer, show the drug met its primary endpoints and details have been published in the British Journal of Cancer. A total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had more than 50% biomarker decline.
The study met its primary end point with an OS3-month of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively. See: �A Multinational Phase 2 Study of Nanoliposomal Irinotecan Sucrosofate (PEP02 MM-398) for Patients with Gemcitabine-Refractory Metastatic Pancreatic Cancer� A H Ko et al. British Journal of Cancer, August 2013: 109 (4): p920-925 doi:10.1038/bjc.2013.408