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This phase II bridging study assessed the safety and efficacy of nab-paclitaxel/gemcitabine (Metastatic Pancreatic Adenocarcinoma Clinical Trial [MPACT] regimen) in Chinese patients with metastatic pancreatic cancer (MPC). This 3-part sequential study evaluated nab-paclitaxel 125 mg/m2 plus gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks. Part 1 evaluated safety. Part 2 evaluated efficacy using Simon’s optimal 2-stage design: if >2 responses were observed in Stage 1 (n = 28), 54 additional patients would be enrolled in Stage 2. If >9 responses were observed, the study was complete. Otherwise, nab-paclitaxel/gemcitabine would be compared with gemcitabine alone in Part 3. The primary endpoint was overall response rate (ORR). Secondary endpoints included duration of response (DOR), overall survival (OS), and safety. Eighty-three patients were treated. The prespecified primary endpoint was met: the independently assessed ORR in Stages 1 + 2 was 35% (95% CI, 24.8–46.2); therefore, Part 3 was not initiated. The median DOR was 8.9 months (95% CI, 6.01–8.94). The median OS and progression-free survival were 9.2 (95% CI, 7.6–11.1) and 5.5 (95% CI, 5.29–7.16) months, respectively. The 12-month OS rate was 30%. In an updated analysis, the median OS was 9.3 months and the 12-month OS rate was 32%. Longer OS was observed in patients with baseline neutrophil-to-lymphocyte ratio ≤ 5 vs > 5. The most common grade ≥ 3 adverse events were leukopenia (35%), neutropenia (34%), anemia (15%), thrombocytopenia (10%), and fatigue (13%). Grade 3 peripheral neuropathy occurred in 7% of patients (no grade 4 reported). The MPACT regimen of nab-paclitaxel/gemcitabine is efficacious in Chinese patients with MPC. No new safety signals were observed. NCT02135822 , May 8, 2014.

TPS9107Background: Effective second-line chemotherapeutic treatment options for pts with NSCLC are limited. Pembro, a PD-1–blocking antibody, has demonstrated antitumor activity and proven second-l...

6029Background: For pts with advanced NPC, no approved chemotherapy is available in the second-line setting or beyond, and treatment options are limited. Hypermethylation contributes to the initiat...

327 Background: nab-P + Gem demonstrated significantly better overall survival (OS; median: 8.7 vs 6.6 mo; HR 0.72; P < 0.001) than Gem alone as first-line treatment for pts with MPC in the MPACT study. This phase II bridging study evaluated efficacy and safety of nab-P + Gem in Chinese pts with MPC. Methods: Efficacy and safety of nab-P 125 mg/m2 + Gem 1000 mg/m2 on days 1, 8, and 15 every 4 weeks was evaluated in a 3-part sequential study. In part 1, safety was examined. In part 2, efficacy was evaluated by the Simon optimal 2-stage design. If there were > 2 responses in 28 pts in stage 1 of part 2, an additional 54 pts would be treated in stage 2. The study would be completed if > 9 responses were observed. If there was an insufficient number of responses in either stage of part 2, part 3 would be triggered to compare nab-P + Gem vs Gem alone. The primary endpoint was overall response rate (ORR). Secondary endpoints included duration of response (DOR), OS, and safety. Correlation of OS and baseline neutrophil-to-lymphocyte ratio (NLR) was also analyzed. Results: Eighty-three pts were treated. Median age was 57.0 y; 19% were aged > 65 y; baseline Karnofsky performance status was 90 - 100 in 70% of pts and 70 - 80 in 30%. Combining results for stages 1 and 2, ORR was 35% by independent assessment, median DOR was 8.9 mo (95% CI, 6.01 - 8.94), median OS and PFS were 9.2 mo (95% CI, 7.60 - 11.10) and 5.5 mo (95% CI, 5.29 - 7.16), respectively (Table). Baseline NLR ≤ 5 was associated with a nonsignificant trend toward longer OS vs NLR > 5 (median, 10.0 vs 8.3 mo; HR 0.62; P= 0.148). The most common grade ≥ 3 adverse events included neutropenia (37%), leukopenia (31%), and fatigue (14%). Grade ≥ 3 peripheral neuropathy occurred in 7% of pts. Part 3 was not triggered per study design. Conclusions: nab-P + Gem demonstrated efficacy in Chinese pts with MPC. The OS and ORR were numerically better than those of the phase III MPACT trial (Table). A trend toward longer OS in pts with baseline NLR ≤ 5 vs > 5 confirmed previous findings from the MPACT study. No new safety signals were identified. Clinical trial information: NCT02135822. [Table: see text]