The U. S. Food and Drug Administration (FDA) has granted MM- 398 plus 5-fluorouracil (5-FU) and leucovorin a Fast Track designation as a second-line treatment for patients with metastatic pancreatic cancer, based on data from the phase III NAPOLI-1 study that were presented at the 2014 World Congress on Gastrointestinal Cancer in June 2014.
MM-398 is a nanoliposomal encapsulation of irinotecan, a drug already approved and widely used in the management of pancreatic and other cancers. The phase III open-label NAPOLI-1 trial enrolled 417 patients with gemcitabine-refractory metastatic pancreatic cancer to be treated with either MM-398, 5-fluorouracil (5-FU) with leucovorin, or MM-398 plus 5-FU and leucovorin.
Patients treated with the combination had the best outcome with an average survival of 6.1 months versus 4.2 months with 5-FU and leucovorin alone. Combination treatment extended survival by 37% and progression-free survival (PFS) by 44%, when compared with 5-FU and leucovorin alone for patients with metastatic pancreatic cancer following progression on a gemcitabine-based regimen.
MM-398 alone did not demonstrate improved outcomes when compared directly with 5-FU and leucovorin. The Fast Track designation given by the FDA is meant to expedite the development and review of MM-398.
Reference: Wang-Gillam A, et al. NAPOLI-1: Randomized Phase 3 Study of MM-398 (nal-IRI), with or without 5-Fluorouracil and Leucovorin, versus 5-Fluorouracil and Leucovorin, in Metastatic Pancreatic Cancer Progressed on or Following Gemcitabine-based Therapy (Abstract #O-0003). ESMO 2014.