Treatment options for pts with LAPC are limited. In the phase 3 MPACT trial, nab-P + G treatment (Tx) resulted in a > 3-fold reduction in primary pancreatic tumor burden vs G in pts with metastatic PC, suggesting that the regimen may be effective in LAPC. Interim efficacy and safety results from the international, multicenter, prospective phase 2 LAPACT trial are presented.
During induction, treatment-naive pts with unresectable LAPC and ECOG PS ≤ 1 received 6 cycles of nab-P 125 mg/m2 + G 1000 mg/m2 on D 1, 8, and 15 of each 28-day cycle. After induction, pts without PD or unacceptable AEs were eligible for the investigator’s choice (IC) of continued Tx with nab-P + G, chemoradiation (CRT), or surgery. Surgery could occur prior to completing 6 cycles if the investigator deemed a sufficient tumor response. The primary endpoint was TTF. A secondary endpoint was disease control rate (DCR = CR, PR, and SD [≥ 16 weeks]) in pts who completed induction and had ≥ 1 postbaseline assessment. Data for pts who received their first dose of Tx by Oct 1, 2016 are reported.
A total of 101 pts with LAPC received nab-P + G induction. Median age was 65 years (range, 42-85), and median time from primary diagnosis to first dose was 27 days. Pts received a median of 5 Tx cycles (range, 1-6). A total of 60 patients (59%) completed induction. Among 93 evaluable patients, the DCR was 82% (76/93; PR, n = 33; SD ≥ 16 wks, n = 43); 12 pts had SD
The reported DCR of 82% and PR rate of 35% for nab-P + G are promising, and there were no new safety signals compared with previous studies. These interim results suggest that nab-P + G is an appropriate LAPC Tx. NCT02301143.
Clinical trial identification
Legal entity responsible for the study
P.A. Philip: Research funding: Celgene, Bayer, Incyte; consultant or advisory role: Celgene; speakers’ bureau: Bayer, Roche, Sanofi, Amgen. J. Lacy, C. Borg: Research funding: Celgene. A. Sobrero: Honoraria: Bayer, Celgene, Merck, Roche, Sanofi. Consulting or advisory role: Amgen, Bayer, Merck, Pfizer; speaker’s bureau: Amgen, BMS, Merck, Sanofi. E.S. Kim: Honoraria, speaker’s bureau, advisory board: GuardantHealth; consultant: Pharmacyclics, Medallion Healthcare; advisory board: Bayer; consultant: Momenta. S. Dowden: Honoraria, advisory role, speaker’s bureau, Amgen, Bayer, Celgene, Lilly, Roche A. Zakari: Speakers bureau, Amgen, Celgene. F. Rivera Herrero: Research funding, Celgene, Bayer, Roche, Amgen, Merck-Serono, MSD, Sanofi, Lilly; consultant or advisory role, Celgene, Bayer, Roche, Amgen, Merck-Serono, MSD, Sanofi, Lilly; speaker’s bureau, Celgene, Bayer, Roche, Sanofi, Amgen, Lilly. J. Shiansong Li, T.J. Ong, T. Nydam: Employment, stock ownership: Celgene. P. Hammel: Consultant or advisory role, honoraria, travel accommodations, expenses: Celgene. All other authors have declared no conflicts of interest.