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Gastrointestinal tumours, non-colorectal

3707 - Final results of NAPOLI-1: A phase 3 study of nal-IRI (MM-398) ± 5-fluorouracil and leucovorin (5-FU/LV) vs 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy


08 Oct 2016


Gastrointestinal tumours, non-colorectal


Li-Tzong Chen


Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371


L. Chen1, A. Wang-Gillam2, C. Li3, G. Bodoky4, A. Dean5, Y. Shan6, G.S. Jameson7, T. Macarulla8, K. Lee9, D. Cunningham10, J. Blanc11, R. Hubner12, C. Chiu13, G. Schwartsmann14, F. Braiteh15, B. Belanger16, E. Bayever17, F. de Jong18, D.D. von Hoff7, J.T. Siveke19

Author affiliations

  • 1 National Institute Of Cancer Research, National Health Research Institutes, 704 - Tainan/TW
  • 2 Medicine, Washington University School of Medicine, St. Louis/US
  • 3 Medicine, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei/TW
  • 4 Medical Oncology, St. László Teaching Hospital, 1097 - Budapest/HU
  • 5 Cancer Services, St John of God Hospital, 6008 - Subiaco/AU
  • 6 National Cheng Kung University, National Cheng Kung University Hospital, Tainan/TW
  • 7 Medical Oncology, TGen, Phoenix/US
  • 8 Oncology Service, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, 08035 - Barcelona/ES
  • 9 Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 10 Gi & Lymphoma Unit, Royal Marsden Hospital, SM2 5PT - Sutton/GB
  • 11 Hepato-gastroenterology And Digestive Oncology, Hôpital Saint-André, Bordeaux/FR
  • 12 Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 13 Cancer Center, China Medical University Hospital, Taichung/TW
  • 14 Ufrgs, Hospital de Clínicas de Porto Alegre, Porto Alegre/BR
  • 15 Medicine, Comprehensive Cancer Centers of Nevada, 89169 - Las Vegas/US
  • 16 Medicine, Merrimack Pharmaceuticals, Inc., Cambridge/US
  • 17 Medicine, Merrimack Pharmaceuticals, 02139 - Cambridge/US
  • 18 Medicine, Baxalta GmbH, Zürich/CH
  • 19 University Hospital Essen, West German Cancer Center, Essen/DE


Abstract 3707


nal-IRI, a liposomal formulation of irinotecan, plus 5-FU/LV is approved in the US for patients (pts) with mPAC previously treated with gemcitabine-based therapy. Primary analysis (data cutoff, Feb 14, 2014) of the NAPOLI-1 trial (NCT01494506) showed that, after 313 events, nal-IRI + 5-FU/LV significantly improved median overall survival (OS) vs 5-FU/LV (6.1 vs 4.2 mo; HR 0.67; 95% CI 0.49-0.92; P = 0.012; Wang-Gillam et al, Lancet. 2016). Here we report the final analysis of NAPOLI-1 (data cutoff, Nov 16, 2015).


417 pts were randomly assigned to nal-IRI 70 mg/m2 (equivalent to 80 mg/m2 irinotecan HCl trihydrate salt) + 5-FU/LV 2400/400 mg/m2 q2w (n = 117), nal-IRI 100 mg/m2 (equivalent to 120 mg/m2 irinotecan HCl trihydrate salt) q3w (n = 151), or 5-FU/LV 2000/200 mg/m2 weekly for weeks 1-4 q6w (n = 149). Log-rank P values are 2-sided.


After 382 events, median OS was improved with nal-IRI + 5-FU/LV vs 5-FU/LV (6.2 vs 4.2 mo; HR 0.75; 95% CI 0.57-0.99; P = 0.038), but not for nal-IRI vs 5-FU/LV (4.9 vs 4.2 mo; HR 1.07; 95% CI 0.84-1.36; P = 0.567). Kaplan-Meier estimates of OS for nal-IRI + 5-FU/LV and 5-FU/LV, respectively, were 53% and 38% at 6 mo, and 26% and 16% at 12 mo. Median progression-free survival was longer for nal-IRI + 5-FU/LV vs 5-FU/LV (3.1 vs 1.5 mo; HR 0.57; 95% CI 0.43-0.76; P 


Final results from NAPOLI-1 continue to show OS benefit for nal-IRI + 5-FU/LV vs 5-FU/LV. No new safety concerns were identified. nal-IRI + 5-FU/LV provides a new treatment option for pts with mPAC previously treated with gemcitabine-based therapy.

Clinical trial identification


Legal entity responsible for the study

Merrimack Pharmaceuticals, Inc.


Merrimack Pharmaceuticals, Inc.


L-T. Chen: Merrimack/ NAPOLI-1 study Steering Committee Member, uncompensated. Advisory Meeting, honorarium: Baxalta. Consultant, honorarium: PharmaEngine. A. Wang-Gillam: Advisory Board: Merrimack, Pfizer. A. Dean: Investigator meeting, travel grant: Merrimack. D. Cunningham: Research funding to institution: Amgen, AstraZeneca, Bayer, Celgene, Medimmune, Merck Serono, Merrimack, Sanofi. J-F. Blanc: Honoraria: Baxalta. F. Braiteh: Research funding: Merrimack. B. Belanger: Employee of Merrimack. E. Bayever: Former employee, stock options: Merrimack. F. de Jong: Employee and stock options: Baxalta. D.D. von Hoff: Clinical trial: Merrimack. J.T. Siveke: Advisory Board, Honoraria: Baxalta. All other authors have declared no conflicts of interest.

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