221PD - Efficacy and safety of nanoliposomal irinotecan (nal-IRI, MM-398, PEP02, BAX-2398) in patients with metastatic pancreatic cancer in Asia: A subgrou...

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Gastrointestinal tumours
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Li-Tzong Chen
Citation Annals of Oncology (2016) 27 (suppl_9): ix68-ix85. 10.1093/annonc/mdw582
Authors L. Chen1, C. Li2, C. Chiu3, Y. Shan4, J.O. Park5, J. Chen6, J.S. Kim7, K. Rau8, F. de Jong9, M. Pipas10, B. Belanger11, E. Wang12, K. Lee13, Y. Bang14
  • 1Oncology, National Health Research Institutes - National Institute of Cancer Research, 704 Tainen - Tainan/TW
  • 2Oncology, Taipei Veterans General Hospital, Taipei/TW
  • 3Medical Oncology, China Medical University Hospital, Taichung/TW
  • 4Institute Of Clinical Medicine, NCKU, Tainan/TW
  • 5Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul/KR
  • 6Division Of Hematology-oncology, Chang Gung Memorial Hospital-Linkou, 333 - Taoyuan/TW
  • 7Oncology, Korea University Guro Hospital, Seoul/KR
  • 8Oncology, Chang Gung Memorial Hospital-Kaohsiung, Kaohsiung/TW
  • 9Medical Affairs, Oncology, Shire, Baxalta GmbH, Zürich/CH
  • 10Medicine, Merrimack Pharmaceuticals, Inc., Cambridge/US
  • 11Biostatistics, Merrimack Pharmaceuticals, Inc., Cambridge/US
  • 12Drug Development, PharmaEngine, Taipei/TW
  • 13Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 14Medical Oncology, Seoul National University Hospital, 110-744 - Seoul/KR

Abstract

Background

The global Phase 3 trial, NAPOLI-1, demonstrated that nal-IRI + 5-fluorouracil and leucovorin (5-FU/LV) significantly improved overall (OS), progression-free survival (PFS) and objective response rate (ORR) vs 5-FU/LV in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPAC) previously treated with gemcitabine-based therapy. Herein, we present a post hoc subgroup analysis of the Asia cohort in the NAPOLI-1 study.

Methods

Pts were randomly assigned (1:1:1) to receive nal-IRI (80 mg/m2, equivalent to 70 mg/m2 of irinotecan base) + 5-FU/LV (2400/400 mg/m2) q2w, nal-IRI (120 mg/m2, equivalent to 100 mg/m2 of irinotecan base) q3w, or 5-FU/LV (2000/200 mg/m2 weekly for weeks 1-4 q6w). The primary endpoint was OS.

Results

Of 132 pts randomized in Asian centers, 34 were assigned to treatment with nal-IRI+5-FU/LV, 50 with nal-IRI, and 48 with 5-FU/LV. In the Asia cohort, nal-IRI+5-FU/LV significantly improved median OS versus 5-FU/LV (8.9 vs 3.7 months, P = 0.0281) (Table). Improvements in PFS and ORR were also observed. There were no significant differences in outcomes between 5-FU/LV and nal-IRI monotherapy. Grade ≥3 treatment-emergent adverse events in ≥ 15% of pts in either nal-IRI arm were neutropenia (55%, 34%, and 2% in the nal-IRI+5-FU/LV, nal-IRI, and 5-FU/LV arms, respectively), white blood cell count decreased (21%, 8%, 0%), diarrhea (3%, 16%, 5%), and anemia (18%, 24%, 14%). There were no cases of Grade ≥3 peripheral neuropathy.

Conclusions

This subgroup analysis confirmed that nal-IRI+5-FU/LV is an efficacious treatment option with a manageable safety profile in patients with mPAC treated in Asia. Nal-IRI+5-FU/LV may represent a new standard of care for patients with mPAC previously treated with gemcitabine-based therapy.

Clinical trial indentification

NCT01494506.

Legal entity responsible for the study

Merrimack

Funding

Merrimack

Disclosure

L-T. Chen: Received data monitoring board, statistician, and support of medical writer from Merirmack, and honorarium from PharmaEngine, Inc. F. de Jong: Employee of and hold stock in Shire. M. Pipas: Employee of and hold stock in Merrimack. B. Belanger: Employee of, hold stock in, and have received reimbursement for travel/accommodations/expenses from Merrimack. E. Wang: Employee of PharmaEngine, Inc. The company has the licensing partnership with Merrimack Pharmaceuticals for the product. Y-J. Bang: Consultant for Merrimack. All other authors have declared no conflicts of interest.