NAPOLI-1: MM-398 Combo Shows Benefit in Metastatic Pancreatic Cancer

The addition of the novel agent MM-398 to second-line 5-FU/leucovorin extended survival in patients with metastatic pancreatic cancer, according to an expanded analysis of the phase 3 NAPOLI-1 trial presented at the Gastrointestinal Cancer Symposium.

Combining MM-398, a nanoliposomal encapsulation of irinotecan, with 5-fluorouracil (FU)/leucovorin chemotherapy resulted in a significant improvement in overall survival compared with 5-FU/leucovorin alone in patients with metastatic pancreatic cancer. A median overall survival of 8.9 months was achieved in patients assigned the drug combination who received 80% or greater dose intensity during the first 6 weeks of treatment.

MM-398 (Merrimack Pharmaceuticals), which received fast track designation from the FDA based on its activity in this combination, is a nanotherapeutic derivative of the chemotherapy drug irinotecan. In this form, in which it is encapsulated in a lipid sphere, the agent can circulate longer than standard irinotecan.

In the NAPOLI-1 trial, Li-Tzong Chen, MD, PhD, of the National Institute of Cancer Research at National Health Research Institutes in Taiwan, and colleagues enrolled 417 patients from 76 sites in 14 countries. All patients had metastatic pancreatic cancer and had undergone prior treatment with gemcitabine-based therapy.

The addition of MM-398 increased the median overall survival by 1.9 months (6.1 versus 4.2 months) — a statistically significant difference.