NAPOLI-1

NCT01494506 📎

Regimen

Experimental
Nanoliposomal irinotecan (nal-IRI, MM-398) 70 mg/m2 IV + 5-FU 2400 mg/m2 / leucovorin 400 mg/m2 q2w. Third arm: nal-IRI monotherapy 100 mg/m2 q3w (did not meet endpoint).
Control
5-FU 2000 mg/m2 + leucovorin 200 mg/m2 weekly x 4 of 6 weeks.

Population

Metastatic PDAC after progression on prior gemcitabine-based therapy, ECOG KPS ≥70, global multicenter (76 sites, 14 countries).

Key finding

NAPOLI-1 established nal-IRI + 5-FU/LV as the first FDA-approved (October 2015) and guideline-endorsed 2L regimen after gemcitabine-based failure in metastatic PDAC. OS gain of ~2 months is modest but meaningful in this heavily pretreated population.

Source: PMID 26615328

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.65)