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e-Poster Display Session

193P - First-line liposomal irinotecan + 5 fluorouracil/leucovorin + oxaliplatin in patients with pancreatic ductal adenocarcinoma: Exploratory survival analyses by change in post treatment CA 19-9


22 Nov 2020


e-Poster Display Session


Tumour Site

Pancreatic Adenocarcinoma


Andrew Dean


Annals of Oncology (2020) 31 (suppl_6): S1287-S1318. 10.1016/annonc/annonc356


A. Dean1, T. Bekaii-Saab2, P.M. Boland3, F. Dayyani4, T. Macarulla Mercade5, K. Mody6, B. Belanger7, F. Maxwell8, Y. Moore7, T. Wang7, B. Zhang9, Z.A. Wainberg10

Author affiliations

  • 1 Medical Oncology, Saint John of God Hospital Subiaco, 6008 - Subiaco/AU
  • 2 Medical Oncology Department, Mayo Clinic (ACCRU), 85054 - Phoenix/US
  • 3 Medical Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick/US
  • 4 Medicine, University of California Irvine, 92868 - Orange/US
  • 5 Medical Oncology Dept., Vall d'Hebron Institute of Oncology and University Hospital, 8035 - Barcelona/ES
  • 6 Medical Oncology, Mayo Clinic, 32224 - Jacksonville/US
  • 7 Medical Oncology, Ipsen, Cambridge/US
  • 8 Medical Oncology, Ipsen, Abingdon/GB
  • 9 Oncology Development Dept., Ipsen, Cambridge/US
  • 10 Medicine Hematology And Oncology, University of California Los Angeles, 90095 - Los Angeles/US


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Abstract 193P


Liposomal irinotecan + 5-fluorouracil/leucovorin (5-FU/LV) is approved for adults with metastatic pancreatic ductal adenocarcinoma (mPDAC) following progression with gemcitabine-based therapy. First-line (1L) liposomal irinotecan + 5-FU/LV + oxaliplatin (NALIRIFOX) is being investigated in a phase I/II trial of patients with locally advanced/mPDAC (NCT02551991). Serum CA 19-9 levels are typically elevated in patients with mPDAC and post-treatment reductions in CA 19-9 levels have been associated with prolonged survival. We report the results of an exploratory survival analysis from the phase I/II trial of 1L NALIRIFOX in mPDAC for subgroups defined by post-treatment changes in CA 19-9 level.


Eligible patients were adults with ECOG performance status (PS) ≤ 1 and adequate organ function who received 1L NALIRIFOX (liposomal irinotecan 50 mg/m2 (free base), 5-FU 2400 mg/m2, LV 400 mg/m2, oxaliplatin 60 mg/m2) on days 1 and 15 of each 28-day cycle. Tumors (RECIST v1.1) and serum CA 19-9 were assessed at screening, every 8 weeks and at end of treatment. Progression-free (PFS) and overall survival (OS) were compared for subgroups defined by best change in CA 19-9 level over the first 16 weeks of treatment (≥ 20% and ≥ 50% decrease; data cut-off 26 Feb 2020).


In total, 32 patients were eligible for the trial, of whom 30 had a baseline CA 19-9 measurement (median [range] 315.5 [2–127115] U/mL) and 22 had a repeat CA 19-9 measurement by Week 16 (analysis set). Overall, NALIRIFOX reduced CA 19-9 level: median (range) best change of –49.4 (–100, +376)%. Median OS and PFS were numerically higher in patients with a CA 19-9 decrease ≥ 20% by Week 16 (Table) Table: 193P

All N = 32 Analysis set n = 22 Analysis set, by best change in CA 19-9 by Week 16
≥ 20% decrease ≥ 50% decrease
Yes n = 14 No n = 8 Yes n = 11 No n = 11
Progressed/died,a n (%) 17 (53.1) 12 (54.5) 6 (42.9) 6 (75.0) 4 (36.4) 8 (72.7)
Median (95% CI) months 9.2 (7.69, 11.96) 9.6 (7.59, 32.30) 32.3 (7.95, 32.30) 7.6 (1.48, 9.56) 11.2 (7.95, NE) 7.6 (1.48, 32.30)
HR (95% CI) 0.13 (0.04, 0.50) 0.33 (0.09, 1.12)
Died, n (%) 20 (62.5) 14 (63.6) 7 (50.0) 7 (87.5) 6 (54.6) 8 (72.7)
Median (95% CI) months 12.6 (8.74, 18.69) 12.7 (8.74, 22.54) 22.5 (12.39, NE) 8.2 (2.50, 18.69) 22.5 (11.60, 22.54) 9.2 (4.83, NE)
HR (95% CI) 0.24 (0.08, 0.75) 0.55 (0.19, 1.60)

a Patients who progressed/died after new therapy or >16 weeks after last non-progressive disease assessment were censored.



1L NALIRIFOX reduced CA 19-9 levels in patients with locally advanced/mPDAC. CA 19-9 is a potential biomarker of post-NALIRIFOX outcomes in these patients.

Clinical trial identification


Editorial acknowledgement

Alison Chisholm of Oxford PharmaGenesis, Oxford, UK, provided medical writing and editorial support, which was sponsored by Ipsen, in accordance with Good Publication Practice guidelines.

Legal entity responsible for the study





A. Dean: Non-remunerated activity/ies: Shire; Non-remunerated activity/ies: Specialised Therapeutics; Travel/Accommodation/Expenses: Amgen. T. Bekaii-Saab: Advisory/Consultancy: Amgen; Advisory/Consultancy: Bayer; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Celgene; Advisory/Consultancy: Genetech/Roche; Advisory/Consultancy: Glenmark; Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy: Merrimack; Advisory/Consultancy: NCCN; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Research to Practice; Advisory/Consultancy: Sirtex Medical; Advisory/Consultancy: Taiho Pharmaceutical. P.M. Boland: Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Boston Biomedical; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Cascadian Therapeutics; Research grant/Funding (institution): Advaxis; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Honoraria (self): Sirtex; Advisory/Consultancy: Merrimack. F. Dayyani: Speaker Bureau/Expert testimony, Research grant/Funding (institution): Amgen; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Bristol-Meyers Sqibb; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Exelixis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Taiho Pharmaceuticals; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eisai; Advisory/Consultancy: Foundation Medecine; Advisory/Consultancy: Genentech; Advisory/Consultancy, Speaker Bureau/Expert testimony: Natera; Advisory/Consultancy: QED Therapetuics; Speaker Bureau/Expert testimony: Deciphera Pharmaceuticals; Speaker Bureau/Expert testimony: Sirtex Medical; Spouse/Financial dependant: Roche Diagnostics. T. Macarulla Mercade: Honoraria (self), Advisory/Consultancy: Genzyme; Honoraria (self), Speaker Bureau/Expert testimony: Sanofi; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self): Tesaro; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Shire; Honoraria (self): Lilly; Honoraria (self): Ipsen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Celgene; Advisory/Consultancy: QDE; Advisory/Consultancy: H3B; Advisory/Consultancy: Baxalta; Advisory/Consultancy: Incyte; Advisory/Consultancy: Servier; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Agios; Research grant/Funding (institution): Aslan; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Halozyme; Research grant/Funding (institution): Immunomedics. K. Mody: Research grant/Funding (institution): Agios; Research grant/Funding (institution): Senwha Biosciences; Research grant/Funding (institution): Taiho; Research grant/Funding (institution): ArQule; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Puma Biotechnology; Research grant/Funding (institution), award # NCI/NIH P50 CA210964: National Cancer Institute (NCI) of the National Institutes of Health; Advisory/Consultancy: Bayer; Advisory/Consultancy: Celgene; Advisory/Consultancy: Eisai; Advisory/Consultancy: Exelixis; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Merrimack; Advisory/Consultancy: Vicus. B. Belanger: Full/Part-time employment: Ipsen. F. Maxwell: Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. Y. Moore: Leadership role, Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. T. Wang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. B. Zhang: Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment: Ipsen. Z.A. Wainberg: Advisory/Consultancy: Ipsen; Advisory/Consultancy: Merck; Advisory/Consultancy: Lilly; Advisory/Consultancy: QED; Advisory/Consultancy: Daiichi; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer.

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