746TiPAPACT: A PHASE III TRIAL OF NAB-PACLITAXEL (NAB-P) PLUS GEMCITABINE (GEM) VS GEM ALONE FOR RESECTED PANCREATIC CANCER (PC).

ABSTRACT Background: Gem monotherapy after surgery improves both survival rates and disease-free survival (DFS) in patients with PC. However, disease recurrence is common, suggesting a need for improved regimens. nab-P + Gem demonstrated superior efficacy to Gem alone in a phase III metastatic PC trial, including the primary endpoint of overall survival (OS [8.7 vs 6.6 months; hazard ratio (HR) 0.72; P Trial design: Approximately 800 patients with histologically confirmed pancreatic cancer who undergo macroscopic complete resection (R0 or R1), with no evidence of metastasis, will be randomized 1:1 to receive 6 cycles of either nab-P 125 mg/m2 plus Gem 1000 mg/m2 or Gem alone 1000 mg/m2 days 1, 8, and 15 of each 28-day cycle. Other eligibility criteria include staging T1-3, N0-1, M0; ECOG PS 0 or 1; acceptable hematologic function; CA19-9 Disclosure: M.A. Tempero: Consultant or advisory role and research funding, Celgene; A. Biankin: Consultant or advisory role, Celgene; D. Goldstein: Consultant of advisory role unremunerated and research funding, Celgene; M. Moore: Consultant of advisory role and honoraria, Celgene; E.M. O'Reilly: Consultant or advisory role, Celgene; P.A. Philip: Consultant: BMS, Bayer/Onyx, SA, Curis, Lilly, Amgen, Clovis, BI, GHI, Roche, Gilead, NVS, TLOG; Honoraria: Amgen, NVS, GNE, Bayer/Onyx, Roche, SA, Celgene; Research funding: GNE, BMS, NVS, Genvec, Chugai, Nektar, Amgen, Lilly, Roche, Bayer, Incyte, SA; H. Riess: Consultant or advisory role, Celgene; L. Yung, X. Wei and B. Lu: Employment or leadership position and stock ownership, Celgene. All other authors have declared no conflicts of interest.