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Poster display session

132P - Liposomal irinotecan (nal-IRI) plus 5-fluorouracil/levoleucovorin (5 FU/LV) vs 5-FU/LV in Japanese patients (pts) with gemcitabine-refractory metastatic pancreatic cancer (mPAC)


23 Nov 2019


Poster display session


Tumour Site

Pancreatic Adenocarcinoma


Tatsuya Ioka


Annals of Oncology (2019) 30 (suppl_9): ix42-ix67. 10.1093/annonc/mdz422


T. Ioka1, S. Nakamori2, K. Sugimori3, M. Kanai4, M. Ikeda5, M. Ozaka6, M. Furukawa7, T. Okusaka8, K. Kawabe9, J. Furuse10, Y. Komatsu11, A. Sato12, S. Shimizu13, P. Chugh14, R. Tang15, M. Ueno16

Author affiliations

  • 1 Department Of Cancer Survey And Gastrointestinal Oncology, Osaka International Cancer Institute, 541-8567 - Osaka/JP
  • 2 Department Of Surgery, NHO Osaka National Hospital, Osaka/JP
  • 3 Gastroenterological Center, Yokohama City University Medical Center, Yokohama/JP
  • 4 Department Of Medical Oncology, Kyoto University Hospital, Kyoto/JP
  • 5 Department Of Hepatobiliary And Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa/JP
  • 6 Department Of Gastroenterology, Cancer Institute Hospital of JFCR, Tokyo/JP
  • 7 Department Of Gastroenterology/hepatology/pancreatology, NHO Kyushu Cancer Center, Fukuoka/JP
  • 8 Department Of Hepatobiliary And Pancreatic Oncology, National Cancer Center Hospital, Tokyo/JP
  • 9 Department Of Medicine And Bioregulatory Sciences, Graduate School Of Medical Sciences, Kyushu University, Fukuoka/JP
  • 10 Department Of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Tokyo/JP
  • 11 Cancer Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 12 Department Of Oncology, Hirosaki University Hospital, 036-8562 - Hirosaki/JP
  • 13 Department Of Gastroenterology, Saitama Cancer Center, Saitama/JP
  • 14 Clinical Science, Servier Pharmaceuticals, Boston/US
  • 15 Biostatistics And Programming, Servier Pharmaceuticals, Boston/US
  • 16 Department Of Gastroenterology, Hepatobiliary And Pancreatic Medical Oncology Division, Kanagawa Cancer Center, 2410815 - Yokohama/JP


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Abstract 132P


In the NAPOLI-1 phase 3 trial, nal-IRI+5-FU/LV significantly increased median PFS (mPFS) vs 5-FU/LV (3.1 vs 1.5 months [mo], unstratified HR = 0.56, P = 0.0001) in pts with mPAC that progressed on prior gemcitabine-based therapy. This randomised phase 2 trial evaluated nalIRI+5FU/LV vs 5-FU/LV in Japanese pts with gemcitabine-refractory mPAC (NCT02697058).Table:


nal-IRI+5-FU/ LV n = 405-FU/ LV n = 39
PFS, mo (investigator assessed)
95% CI1.5–5.01.4–1.6
95% CI0.37–0.98
PFS, mo (independently assessed)
95% CI1.5–3.61.4–1.6
95% CI0.47–1.32
Best overall response, n (%)40 (100.0)39 (100.0)
ORR8 (20.0)1 (2.6)
Disease control rate, n (%)8 (20.0)2 (5.1)
OS, mo
95% CI5.2–NR6.1–NR
95% CI0.88–3.16
TTF, mo
95% CI1.5–2.21.4–1.6
95% CI0.44–1.12
CA19-9 response rate,n/evaluable population (%)5/28 (17.9)1/28 (3.6)


This study assessed nal-IRI+5-FU/LV tolerability as per the NAPOLI-1 dosing regimen (Part 1), and safety and efficacy (Part 2). Part 2 outcomes are reported. Pts were randomised 1:1 and stratified by KPS (70 and 80 vs ≥ 90) and baseline albumin (≥4.0 g/dL vs < 4.0 g/dL). Primary endpoint was PFS; secondary endpoints were ORR, DCR, OS, TTF, CA199 response and QoL. The ITT population comprised all pts randomised.


Differences in pt baseline characteristics were noted in the nal-IRI+5-FU/LV (n = 40/79) vs 5FU/LV (n = 39/79) arms, e.g. hepatic lesions (63% vs 51%), stage IV disease at diagnosis (78% vs 51%), and post-study anticancer therapy (55% vs 72%). Efficacy results are shown in the table. Investigator-assessed mPFS increase with nal-IRI+5-FU/LV was clinically meaningful and statistically significant vs 5-FU/LV (2.7 vs 1.5 mo, P = 0.039). Independently-assessed mPFS showed a similar trend (1.7 vs 1.6 mo, P = 0.376). mOS was 6.3 mo with nal-IRI+5-FU/LV and not reached with 5-FU/LV. DCR, TTF, CA19-9 and ORR response increased, ORR significantly, with nalIRI+5-FU/LV vs 5-FU/LV. The most commonly reported grade ≥3 TEAEs with nal-IRI+5-FU/LV vs 5-FU/LV were decreased neutrophil count (37% vs 3%), decreased white blood cell count (20% vs 0) and diarrhoea (17% vs 3%).


Treatment with nal-IRI+5-FU/LV was associated with clinically meaningful and statistically significant gains in investigator-assessed mPFS and ORR vs 5-FU/LV in Japanese patients, with no new or unexpected safety signals in this population.

Clinical trial identification


Editorial acknowledgement

Medical writing support was provided by Christopher Lamb of Physicians World Europe GmbH, Mannheim, Germany and was funded by Servier Global Medical Affairs (Suresnes, France).

Legal entity responsible for the study

Servier and the authors.




T. Ioka: Advisory / Consultancy: Shire. M. Kanai: Advisory / Consultancy, Shareholder / Stockholder / Stock options: TheraBioPharma Inc. M. Ikeda: Advisory / Consultancy: Shire; Advisory / Consultancy, Research grant / Funding (self): Bayer Yakuhin; Advisory / Consultancy, Research grant / Funding (self): Eisai; Advisory / Consultancy: Novartis Pharma; Advisory / Consultancy: MSD; Research grant / Funding (self): Kyowa Hakko Kirin; Research grant / Funding (self): Yakult; Research grant / Funding (self): Eli Lilly Japan; Research grant / Funding (self): Ono pharmaceutical; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Baxalta Japan Limited; Research grant / Funding (self): Chugai Pharmaceutical; Research grant / Funding (self): Bristol-Myers Squibb; Research grant / Funding (self): Merck Serono; Research grant / Funding (self): Nano Carrier; Research grant / Funding (self): ASLAN Pharmaceuticals; Research grant / Funding (self): Novartis Pharma; Research grant / Funding (self): Takar Bio. T. Okusaka: Honoraria (self): Meiji Seika Pharma ; Honoraria (self): MSD; Honoraria (self): AbbVie Inc.; Honoraria (self), Research grant / Funding (self): Eisai Co., Ltd.; Honoraria (self): Yakult Honsha Co., Ltd.; Honoraria (self): Shire; Honoraria (self): ; Honoraria (self): Daiichi Sankyo Co., Ltd.; Honoraria (self): Taiho Pharmaceutical Co., Ltd; Honoraria (self): Takeda Pharmaceutical Co., Ltd.; Honoraria (self): Chugai Pharmaceutical Co., Ltd.; Honoraria (self): Teijin Pharma Ltd.; Honoraria (self): Eli Lilly Japan K.K.; Honoraria (self): Novartis Pharma K.K.; Honoraria (self): Nobelpharma Co., Ltd.; Honoraria (self): Bayer Yakuhin, Ltd.; Honoraria (self): Pfizer Japan Inc.; Honoraria (self): FUJIFILM RI Pharma Co., Ltd ; Honoraria (self), Research grant / Funding (self): Bristol-Myers K.K.; Research grant / Funding (self): AstraZeneca K.K.; Research grant / Funding (self): Baxter. J. Furuse: Advisory / Consultancy: Shire. Y. Komatsu: Advisory / Consultancy: Yakult; Advisory / Consultancy: Taiho; Advisory / Consultancy: Lilly. S. Shimizu: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Incyte Corporation; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Baxalta Japan; Research grant / Funding (institution): Taiho Pharmaceutical; Research grant / Funding (institution): Sumitomo Dainippon Pharma; Research grant / Funding (institution): Yakult; Research grant / Funding (institution): IQVIA Services Japan. P. Chugh: Full / Part-time employment: Servier. R. Tang: Full / Part-time employment: Servier. M. Ueno: Honoraria (self), Research grant / Funding (institution): Taiho Pharmaceutical; Honoraria (self): Yakult Honsha; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self): Novartis; Honoraria (self): Lilly; Honoraria (self): Teijin Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Shire; Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Merck Serono; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): MSD; Research grant / Funding (institution): NanoCarrier; Research grant / Funding (institution): Dainippon Sumitomo Pharma; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): ASLAN Pharmaceuticals. All other authors have declared no conflicts of interest.

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