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Aim: nab-P + Gem demonstrated superior efficacy over Gem alone in the MPACT trial of patients with metastatic PC. An updated analysis confirmed the superior OS (primary endpoint) of nab-P + Gem vs Gem alone (8.7 vs 6.6 mo; HR 0.72; P Methods: Previously untreated pts with metastatic PC were randomized 1:1—stratified by performance status, region (Australia [AU], Eastern Europe [EE], Western Europe [WE], or North America [NA]), and the presence of liver metastases—to receive nab-P 125 mg/m2 + Gem 1000 mg/m2 on d 1, 8, and 15 of each 28-day cycle or Gem 1000 mg/m2 weekly for 7 weeks followed by 1 week of rest (cycle 1) and then d 1, 8, and 15 of each 28-day cycle (cycle ≥ 2). Results: The analysis included 861 pts. An updated OS analysis (data cutoff 9 May 2013) revealed that OS was longer for nab-P + Gem vs Gem alone in each region, although the difference was not statistically significant in all cases (table). Similar trends were observed for PFS and ORR. White blood cell growth factors were used at the following rates (nab-P + Gem vs Gem): NA, 28% vs 16%; EE, 16% vs 13%; AU, 16% vs 12%; WE, 37% vs 11%. The safety profile of each treatment arm was similar across the regions. Differences in the proportion of pts receiving post-progression therapies were noted for some regions (nab-P + Gem vs Gem): NA, 40% vs 42%; EE, 20% vs 31%; AU, 39% vs 41%; WE, 45% vs 55%. The rates of use were different across regions for 5-FU/capecitabine-based therapies (NA, 26% vs 31%; EE, 17% vs 26%; AU, 26% vs 22%; WE, 42% vs 47%) and FOLFIRINOX (NA, 6% vs 7%; EE, 0 vs 2%; AU, 2% vs 2%; WE, 3% vs 8%). nab-P + Gem Gem HR (95% CI) P Value n Median OS, mo n Median OS, mo North America 268 8.8 271 6.6 0.69 (0.57-0.82) Eastern Europe 64 7.7 62 5.9 0.84 (0.58-1.23) 0.372 Australia 61 9.4 59 6.7 0.59 (0.40-0.88) 0.010 Western Europe 38 10.7 38 6.9 0.82 (0.48-1.40) 0.471 Conclusions: nab-P + Gem was associated with improved survival compared with Gem alone in pts with metastatic PC, regardless of region. Variations in postprogression therapy use were noted across regions. Disclosure: R.K. Ramanathan: a consultant/advisor to Celgene, receives honoraria and research funding from them as well; D. Goldstein: is a consultant/advisor for Celgene and receives research funding from them; A. Romano: is a Celgene employee and owns stock; D. Penenberg: is a an employee of Celgene and owns stock; D.D. Von Hoff: is a consultant/advisor for Celgene and receives honoraria from them. He also receives research funding from TG Clinical Research. All other authors have declared no conflicts of interest.

Aim: Metastatic PC is associated with one of the worst prognoses among all the types of solid tumors. The presence of LMs and multiple sites of metastasis are factors associated with poorer prognosis. In the MPACT trial, nab-P + Gem demonstrated superior overall survival (OS, primary endpoint) vs Gem alone as first-line treatment for metastatic PC (Table). We report the efficacy and safety of nab-P + Gem vs Gem alone based on the presence of LMs and the number of metastatic sites. Methods: Previously untreated pts (N = 861) with metastatic PC were randomized 1:1 (stratified by performance status, region, and the presence of LMs) to receive nab-P 125 mg/m2 + Gem 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle or Gem alone 1000 mg/m2 weekly for 7 weeks followed by 1 week of rest (cycle 1) and then days 1, 8, and 15 of each 28-day cycle (cycle ≥ 2). Results: Treatment arms were well balanced with respect to LMs and the number of metastatic sites: 84% of pts had LMs and 79% had 2 or 3 metastatic sites. In pts with LMs, median OS was significantly longer with nab-P + Gem vs Gem alone (Table). Similar trends were seen for PFS (5.4 vs 3.6 mo; HR 0.65; P Patient Population n Median OS, mo nab-P + Gem Gem nab-P + Gem Gem HR P Value ITT 431 430 8.5 6.7 0.72 Subgroups With LMs 365 360 8.3 5.9 0.69 No. of metastatic sites 1 33 21 13.5 9.0 0.41 0.021 2 202 206 8.3 7.1 0.75 0.015 3 136 140 8.0 5.9 0.79 0.093 > 3 60 63 8.6 5.0 0.50 0.001 Conclusions: In the MPACT trial, nab-P + Gem demonstrated longer OS vs Gem alone in the ITT population. The results for pts with LMs and in subgroups defined by the number of metastatic sites were consistent with the ITT findings. No new safety signals were observed. Disclosure: C. Weekes: has received honoraria for advisory board participation in the past 3 years from Celgene F. Parnis: servied on the advisory board for Specialised Therapeutics; A. Santoro: is a consultant/advisor to Celgene; A. Romano, D. McGovern and D. Penenberg: is an employee of Celgene and owns stock; D.D. Von Hoff: is a consultant/advisory for Celgene and receives honoraria from them. He also receives research funding from TGen Clinical Research Service. All other authors have declared no conflicts of interest.