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Attend this session at the
2019 ASCO Annual Meeting!

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall A

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Discussion Session

Time: Monday June 3, 3:00 PM to 4:30 PM

Location: Arie Crown Theater

Randomized phase II study of second-line modified FOLFIRI with PARP inhibitor ABT-888 (Veliparib) (NSC-737664) versus FOLFIRI in metastatic pancreatic cancer (mPC): SWOG S1513.

Pancreatic Cancer

Gastrointestinal (Noncolorectal) Cancer

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Discussion Session (Board #119)

J Clin Oncol 37, 2019 (suppl; abstr 4014)

Author(s): E. Gabriela Chiorean, Katherine A Guthrie, Philip Agop Philip, Elizabeth M. Swisher, Florencia Jalikis, Michael J. Pishvaian, Jordan Berlin, Marcus Smith Noel, Jennifer Marie Suga, Ignacio Garrido-Laguna, Dana Backlund Cardin, Danika L. Lew, Andrew M. Lowy, Howard S. Hochster; University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA; SWOG Statistics and Data Management Center, and Fred Hutchinson Cancer Research Center, Seattle, WA; Karmanos Cancer Institute, Detroit, MI; University of Washington School of Medicine, Seattle, WA; University of Washington Medical Center, Seattle, WA; Georgetown University Medical Center, Washington, DC; Vanderbilt University, Nashville, TN; University of Rochester James P. Wilmot Cancer Institute, Strong Memorial Hospital, Rochester, NY; Kaiser Permanente, Vallejo, CA; University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Vanderbilt-Ingram Cancer Center, Nashville, TN; SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA; UCSD Moores Cancer Center, La Jolla, CA; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ

Abstract Disclosures


Background: PC is characterized by DNA Damage Repair (DDR) deficiencies, including in BRCA1/2, ATM, and FANC genes. Given preclinical synergism between veliparib with irinotecan, safety and preliminary efficacy, we designed a randomized phase II study of mFOLFIRI (no 5-FU bolus) + veliparib vs FOLFIRI alone for 2nd line mPC patients (pts). Methods: Eligible pts had mPC, adequate organ function, ECOG PS 0-1, and 1 prior non-irinotecan systemic therapy.143 pts were to be randomized (1:1) to veliparib vs control. Primary endpoint was overall survival (OS). All pts had blood and tumor biopsies at baseline to assess germline and somatic BRCA1/2 mutations (integrated), and homologous recombination (HR) or DDR biomarkers (exploratory). Results: 123 pts were accrued between 09/2016 to 12/2017, and 108 were included in this analysis. 117 pts were biomarker evaluable: 109 blood/106 tumors. 11 cancers (9%) had HR deficiency (HRD), including 4 germline (BRCA1, BRCA2, ATM) and 7 somatic mutations (BRCA2, PALB2, ATM, CDK12). Additional 24 cancers (20%) had germline (n = 11, e.g., FANC, BLM, SLX4, CHEK2) or somatic mutations (n = 13, e.g., FANC, BLM, POLD1, RIF1, MSH2, MSH6) in other DNA repair genes, not classified as HRD. A planned interim futility analysis at 35% of expected PFS events determined the veliparib arm was unlikely to be superior to control. Most common grade 3/4 treatment related toxicities were neutropenia (33% vs 20%), fatigue (19% vs 4%), and nausea (11% vs 4%), for veliparib vs control. Treatment exposure was similar for veliparib vs control: median 4 cycles (range 1-31 vs 1-32). Median OS was 5.1 vs 5.9 mos (HR 1.3, 95%CI 0.9-2.0, p = 0.21), and median PFS was 2.1 vs 2.9 mos (HR 1.5, 95%CI 1.0-2.2, p = 0.05) for veliparib vs control arms, respectively. Correlations of gene mutations and signatures with efficacy outcomes will be presented. Conclusions: Nearly 30% of mPC pts had DNA repair gene abnormalities, including 9% with HRD. Veliparib increased toxicity and did not improve OS when added to mFOLFIRI in biomarker unselected pts. BRCA1/2 and DDR biomarkers will be correlated with efficacy to inform patient selection for future PARP inhibitor clinical trials. Clinical trial information: NCT02890355

Other Abstracts in this Sub-Category:


1. Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial.

Meeting: 2019 ASCO Annual Meeting Abstract No: LBA4 First Author: Hedy L. Kindler
Category: Gastrointestinal (Noncolorectal) Cancer - Pancreatic Cancer


2. APACT: phase III, multicenter, international, open-label, randomized trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) for surgically resected pancreatic adenocarcinoma.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4000 First Author: Margaret A. Tempero
Category: Gastrointestinal (Noncolorectal) Cancer - Pancreatic Cancer


3. Final report of a phase I/II study of veliparib (Vel) in combination with 5-FU and oxaliplatin (FOLFOX) in patients (pts) with metastatic pancreatic cancer (mPDAC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4015 First Author: Michael J. Pishvaian
Category: Gastrointestinal (Noncolorectal) Cancer - Pancreatic Cancer