e-Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2020

First-line liposomal irinotecan + 5‑fluorouracil/leucovorin + oxaliplatin in patients with pancreatic ductal adenocarcinoma: results from a phase 1/2 study (#222)

Andrew Dean 1 , Tanios Bekaii-Saab 2 , Patrick M Boland 3 , Farshid Dayyani 4 , Teresa Macarulla 5 , Kabir Mody 6 , Bruce Belanger 7 , Fiona Maxwell 8 , Yan Moore 7 , Arunthathi Thiagalingam 7 , Tiffany Wang 7 , Bin Zhang 7 , Zev A Wainberg 9
  1. St John of God Subiaco, Subiaco, WA, Australia
  2. Mayo Clinic Cancer Center (MCCC), Scottsdale, Scottsdale, AZ, USA
  3. Rutgers Cancer Institute of New Jersey, , New Brunswick, NJ, USA
  4. University of California,, Irvine, CA, USA
  5. Vall d'Hebron University Hospital, Barcelona, Spain
  6. Mayo Clinic, Jacksonville, FL, USA
  7. Ipsen Bioscience, Inc., Cambridge, MA, USA
  8. Ipsen, Abingdon, UK
  9. University of California, Los Angeles, Medical Center,, Los Angeles, CA, USA


Liposomal irinotecan + 5‑fluorouracil/leucovorin (5-FU/LV) is approved for adults with metastatic pancreatic ductal adenocarcinoma following progression with gemcitabine-based therapy. We report results from an open-label phase 1/2 study (NCT02551991) of adults with untreated, unresectable, locally advanced/metastatic-PDAC receiving liposomal irinotecan + 5-FU/LV + oxaliplatin (NALIRIFOX).


Eligible patients were adults with ECOG performance status (PS)≤ 1 and adequate organ function who received NALIRIFOX (liposomal irinotecan 50mg/m2 (free-base), 5-FU 2400mg/m2, LV 400mg/m2, oxaliplatin 60mg/m2) on days 1 and 15 of each 28-day cycle. The primary endpoint was safety; secondary endpoints included progression-free-survival (PFS), overall survival (OS), best overall response, overall response rate (ORR), 16-week disease control rate (DCR16) and duration of response (DoR). RECIST v1.1 was assessed at 8-week screenings and treatment end.


32 patients were included (median [range] age 58.0 [39–76] years; 43.8% men; 87.5% metastatic disease; 56.3% ECOG PS 1). 22 patients experienced grade ≥3 treatment-emergent-adverse-events (TEAEs): neutropenia (31.3%), febrile neutropenia (12.5%), hypokalemia (12.5%), diarrhea (9.4%), nausea (9.4%) and decreased neutrophil count (9.4%). 17 patients had serious TEAEs: nausea (9.4%) and febrile neutropenia (9.4%). TEAEs led to 3 deaths (none treatment-related), dose-adjustment in 26 and discontinuation in 8 patients. Median (95% CI) PFS and OS were 9.2 (7.69–11.96) months and 12.6 (8.74–18.69) months, respectively. One patient, with locally advanced disease, had complete response, 10 partial response, and 15 stable disease. ORR (95% CI) was 34.4 (18.6–53.2)%, DCR16 was 71.9 (53.3–86.3)% and median (95% CI) DoR was 9.4 (3.52, NE) months.


First-line NALIRIFOX raised no new safety signals in patients with locally advanced/metastatic PDAC; anti-tumour activity was promising. The randomized phase-3 NAPOLI-3 study (NCT04083235) will compare NALIRIFOX with gemcitabine + nab-paclitaxel.


This study is funded by Ipsen.


This abstract was originally presented virtually at the 2020 ESMO World Congress on Gastrointestinal Cancer.