190P - Outcomes from the Asian region of the phase III APACT trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) alone for patients (pts) with resected pancreatic cancer (PC)

Background

APACT was a geographically diverse trial with study sites worldwide, including in Asia; here, we report outcomes from Asian sites.

Methods

Treatment-naive pts with histologically confirmed PC, R0/R1 resection, CA 19-9 < 100 U/mL, and ECOG PS ≤ 1 received 6 cycles of nab-P 125 mg/m² + G 1000 mg/m² or G 1000 mg/m² on days 1, 8, and 15. Stratification factors were resection (R0/R1) and lymph node (LN+/−) status. The primary endpoint was disease-free survival (DFS) by independent review. Secondary endpoints were overall survival (OS) and safety.

Results

At Asian sites (Hong Kong, Korea, Singapore, and Taiwan), 108 pts (of 866 pts from the ITT population) were randomized to nab-P/G (n = 55) or G (n = 53). Median age was 61 years. Most pts had ECOG PS 0 (64%), LN+ disease (61%), and R0 resection (86%). Six treatment cycles were administered in 76% (nab-P/G) vs 77% (G) of pts. Data cutoff was April 3, 2020; median follow-up for OS was 52.6 months. Median independently assessed DFS was 27.6 (nab-P/G) vs 22.6 (G) months (Table); investigator-assessed DFS was 18.0 vs 11.9 months. Median OS was 46.8 (nab-P/G) vs 40.6 (G) months. Analgesics (nab-P/G) and treatments for indigestion (G) were the most common concomitant medications. The most common grade ≥ 3 hematologic and nonhematologic treatment-emergent adverse events (AEs) with nab-P/G vs G were neutropenia (36.4% vs 26.9%) and peripheral neuropathy (10.9% vs 0%). All dose reductions (36 [nab-P/G] vs 21 [G]) were due to AEs (most common, neutropenia); 4 (nab-P/G) vs 0 (G) pts discontinued treatment due to AEs Table: 190P

^a Pts were from sites in Hong Kong (n = 4), Republic of Korea (n = 51), Singapore (n = 6), and Taiwan (n = 47). ^b Based on an April 3, 2020 data cutoff.CI, confidence interval; G, gemcitabine; HR, hazard ratio; Ind. DFS, disease-free survival by independent radiological review; Inv. DFS, disease-free survival by investigator review; ITT, intention-to-treat; NA, not achieved; nab-P, nab-paclitaxel; OS, overall survival.

Conclusions

Consistent with outcomes in the ITT population, DFS and OS were numerically longer with nab-P/G vs G in the Asian cohort. The nab-P/G safety profile was consistent with that seen in the overall treated population.

Clinical trial identification

2013-003398-91; NCT01964430.

Editorial acknowledgement

Writing assistance was provided by Mohan Harihar, of MediTech Media, Ltd., and funded by Bristol-Myers Squibb Company. The authors are fully responsible for all content and editorial decisions for this manuscript.

Legal entity responsible for the study

Bristol-Myers Squibb Company.

Funding

Bristol-Myers Squibb Company.

Disclosure

J. Bendell: Research grant/Funding (institution): Gilead, Genentech-Roche, Bristol-Myers Squibb, Five Prime, Eli Lilly & Co., Merck, MedImmune, Celgene, EMD Serono, Taiho, Macrogenics, GlaxoSmithKline, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Kol; Advisory/Consultancy: Gilead, Genentech-Roche, Bristol-Myers Squibb, Five Prime, Eli Lilly & Co., Merck, MedImmune, Celgene, Taiho, Macrogenics, GlaxoSmithKline, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Array, Sanofi,. B. Garlipp: Research grant/Funding (self): Sirtex; Honoraria (self): Sirtex, Roche, Amgen, Pfizer, Celgene, Merck and Novartis; Advisory/Consultancy: Sirtex, Roche and Amgen; Travel/Accommodation/Expenses: Merck, Amgen, Celgene, B. Braun Travacare. M. Karthaus: Advisory/Consultancy, Travel/Accommodation/Expenses: Helsinn and Riemser. B. Lu: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. D. McGovern: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. S. Banerjee: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. M. Tempero: Research grant/Funding (self): AbbVie, AstraZeneca, Advance Medical, BioPharm Communications, Bristol-Myers Squibb, CPRIT, Eisai, Halozyme, Ignyta, Immunovia, Pharmacyclics LLC, PharmaCyte Biotech, Tocagen. D-Y. Oh: Research grant/Funding (self): AstraZeneca. All other authors have declared no conflicts of interest.