APOLLO: A randomized phase II double-blind study of olaparib versus placebo following curative intent therapy in patients with resected pancreatic cancer and a pathogenic BRCA1, BRCA2 or PALB2 mutation—ECOG-ACRIN EA2192.

Authors

null

Kim Anna Reiss

Abramson Cancer Center, Philadelphia, PA;

Kim Anna Reiss , Sung Chul Hong , Anup Kasi , Eileen Mary O'Reilly , Shishir K. Maithel , Xin Yao , Stanley R. Hamilton , Ben Boursi , Michael J. Pishvaian , Samuel J Klempner , Susan M. Domchek , Paul J. Catalano , E. Gabriela Chiorean , Philip Agop Philip , Peter J. O'Dwyer

Organizations

Abramson Cancer Center, Philadelphia, PA; , Dana-Farber Cancer Institute, Boston, MA; , University of Kansas Medical Center, Westwood, KS; , Memorial Sloan Kettering Cancer Center, New York, NY; , Winship Cancer Institue, Emory University, Atlanta, GA; , ThedaCare Regional Medical Center, Appleton, WI; , City of Hope National Medical Center, Duarte, CA; , Institute of Oncology, Sheba Medical Center, Ramat Gan, Israel; , Johns Hopkins University School of Medicine, Washington, DC; , Massachusetts General Hospital, Boston, MA; , University of Pennsylvania, Abramson Cancer Center, Philadelphia, PA; , University of Washington, Seattle, WA; , Henry Ford Cancer Institute, Detroit, MI; , Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA;

Research Funding

U.S. National Institutes of Health
U.S. National Institutes of Health, PANCAN

Background: A meaningful subset of PDAC is characterized by a homologous recombination deficiency (HRD). The most well-defined patients within this group are those with pathogenic variants in BRCA1, BRCA2 and PALB2. In the metastatic setting, PARP inhibitor maintenance provides a progression-free survival benefit after a period of platinum based chemotherapy1,2, but the role of PARP inhibitors in the curative intent setting is undefined. The OlympiA study established one year of olaparib as the standard of care for patients with BRCA-related, early stage breast cancer who completed all other curative-intent treatment3. Therefore, we have designed a randomized, phase II double-blind study of one year of olaparib vs placebo in patients with pancreatic cancer and a germline or somatic variant in BRCA or PALB2 who have completed all curative intent therapy. Methods: We have enrolled and treated 23 of 152 planned patients on study NCT 04858334/EA2192. Eligibility criteria include: a pathogenic germline or somatic variant in BRCA1, BRCA2 or PALB2 as determined by local laboratory (central review required); completion of curative-intent resection and ≥ three months of multi-agent chemotherapy; no evidence of recurrent disease. At enrollment, patients must be within 12 weeks of their last anti-cancer intervention. Patients are randomized 2:1 to receive oral olaparib 300 mg twice daily or placebo for 12 28-day cycles. The primary endpoint is relapse-free survival. Overall survival is a secondary endpoint. Tumor tissue, fecal material (for microbiome analysis) and serial ctDNA samples are being collected. 1.Golan T, Locker GY, Kindler HL: N Engl J Med 381:1492-1493, 2019. 2. Reiss KA, Mick R, O'Hara MH, et al: J Clin Oncol 39:2497-2505, 2021. 3. Tutt ANJ, Garber JE, Geyer CE, Jr.: N Engl J Med 385:1440, 2021. Clinical trial information: NCT04858334.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2023 ASCO Gastrointestinal Cancers Symposium

Session Type

Trials in Progress Poster Session

Session Title

Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Pancreatic Cancer,Hepatobiliary Cancer,Neuroendocrine/Carcinoid,Small Bowel Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT04858334

Citation

J Clin Oncol 41, 2023 (suppl 4; abstr TPS763)

DOI

10.1200/JCO.2023.41.4_suppl.TPS763

Abstract #

TPS763

Poster Bd #

P19

Abstract Disclosures