176752-195

Randomized, open-label trial of gemcitabine/nab-paclitaxel (G/NP) ± pamrevlumab (P) as neoadjuvant chemotherapy in locally advanced, unresectable pancreatic cancer (LAPC).

Category: 
Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Session Type and Session Title: 
Poster Session B: Cancers of the Pancreas, Small Bowel and Hepatobiliary Tract
Abstract Number: 

365

Poster Board Number: 
Poster Session B Board #G13
Citation: 
J Clin Oncol 35, 2017 (suppl 4S; abstract 365)
Author(s): 
Vincent J. Picozzi, Flavio G. Rocha, Scott Helton, Michael J. Pishvaian, Patrick G Jackson, Kabir Mody, Horacio Asbun, Mairead Carney, Tina Etheridge, Thomas B Neff, Seth Porter, Ming Zhong, Frank Valone, Elias Kouchakji, Joanne C. Imperial, Ewa Carrier; Virginia Mason Medical Center, Seattle, WA; Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Mayo Clinic, Jacksonville, FL; FibroGen, Inc., San Francisco, CA; FibroGen, San Francisco, CA; Fibrogen, San Francisco, CA

Abstract Disclosures

Abstract: 

Background: Pancreatic ductal adenocarcinoma (PDAC) is characterized by dense stroma and connective tissue growth factor (CTGF) overexpression. Although prolonged overall survival (OS) can be achieved through resection, only approximately 15% to 20% of patients are treated with surgery. Previously, pamrevlumab (P), a fully human monoclonal antibody blocking CTGF, was combined with gemcitabine/erlotinib (G/E) in a study of advanced PDAC. P plasma levels of > 150 μg/mL and low baseline CTGF levels resulted in prolonged OS. We hypothesize that neoadjuvant (NA) treatment of LAPC with P + G/nab-paclitaxel (NP) may alter LAPC’s stroma, increase R0 resectability, and improve OS similar to that of patients resectable at presentation. Methods: LAPC subjects, confirmed by NCCN criteria and staging laparoscopy, were randomized 2:1 to G/NP ± P for 6-cycle/24-week treatment. Safety and efficacy (resection rate, OS, progression-free survival, tumor response) were assessed. Resection was performed in subjects who met protocol-defined criteria with no contraindications. Results: As of 26 Sep 2016, 25 subjects were enrolled. Of 14 subjects in Arm A (G/NP + P), 7 completed, 2 discontinued. Of 11 subjects in Arm B (G/NP), 4 completed, 4 discontinued. 6 subjects (43%) in Arm A and 4 (36%) in Arm B experienced SAEs; no P-related SAEs were reported. Out of 7 eligible Arm A subjects, 3 were not resected. Successful resection was achieved in 4 Arm A subjects (3 R0, 1 R1) and 1 Arm B subject (R0) (Table). Conclusions: The combination of G/NP + P is feasible and well-tolerated with no incremental safety signals in this study. The addition of P suggests a trend toward increased resectability among LAPC subjects. Clinical trial information: NCT02210559

Summarized ResultsArm A (G/NP + P) (N = 14)Arm B (G/NP) (N = 11)
Treatment ongoing53
Eligible for Resection (PP)*71
Explored/Not Resected3N/A
R0/R1 Resection (PP)*3/7 (43%) / 1/7 (14%)1/4 (25%) / NA
Resection Rate (ITT)4/9 (45%)1/8 (13%)
Deaths (mean OS)2 (17.6 mo)3 (13.2 mo)

*PP-per protocol are subjects that completed 6 study drug cycles