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E-Poster Display

520TiP - A multicenter study to evaluate the impact of circulating tumor DNA guided therapy (BESPOKE) in patients with stage II and III colorectal cancer

Date

17 Sep 2020

Session

E-Poster Display

Presenters

Pashtoon Kasi

Citation

Annals of Oncology (2020) 31 (suppl_4): S409-S461. 10.1016/annonc/annonc270

Authors

P.M. Kasi1, S. Sawyer2, J. Guilford2, M. Munro2, S. Ellers2, N. Hook2, S. Krinshpun2, S. Moshkevich2, P.R. Billings2, A. Aleshin2

Author affiliations

  • 1 Internal Medicine, University of Iowa Health Care, 52242 - Iowa City/US
  • 2 Oncology, Natera, Inc., 94070 - San Carlos/US
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Resources

Abstract 520TiP

Background

Circulating tumor DNA (ctDNA) testing can potentially help identify minimal/molecular residual disease (MRD) post-curative-intent surgery in patients with colorectal cancer (CRC). ctDNA can be used to identify MRD-negative patients that have already benefited from surgery/definitive therapy and may avoid unnecessary adjuvant chemotherapy. It also allows for consideration and/or intensification of systemic treatment for MRD-positive patients, who ideally need ‘adjuvant’ therapy to avoid relapse. Early detection of MRD using a personalized, tumor-informed ctDNA assay provides a unique opportunity to identify optimal treatment options for patients, which can, in turn, result in improved survival and quality of life in CRC survivors.

Trial design

The study is a prospective, multicenter clinical trial that utilizes a personalized ctDNA assay (SignateraTM bespoke mPCR NGS), designed to track tumor-specific mutations in patients with stage II/III CRC for MRD determination and molecular monitoring. A total of 1,000 patients will be enrolled at >50 US sites and will be followed for up to 2 years with periodic blood collection, timed with the standard-of-care visits (post-operative/surgery visit, prior to initiation of systemic chemotherapy, with each cycle of chemotherapy and with each surveillance visit). Primary objective: To examine the impact of Signatera on adjuvant treatment decisions and to determine the rates of CRC recurrence while asymptomatic. To estimate the true percent of cases with a change in post-surgical treatment, under the assumptions of a ±5% margin of error and a 95% confidence level, a minimum of 921 patients will be enrolled. Secondary endpoints: Determine overall survival, rate of MRD clearance (MRD+ to MRD-), adjuvant treatment rates, surgery and/or locoregional treatment rates for oligometastatic recurrence, patient satisfaction, and physician utility. This will be the first real-world study of MRD testing and will provide one of the largest prospective datasets, with serial blood collection at landmark visits, in patients with stage II/III CRC.

Clinical trial identification

NCT04264702.

Editorial acknowledgement

Editorial assistance was provided by Meenakshi Malhotra, PhD from Natera, Inc. San Carlos, US.

Legal entity responsible for the study

Natera, Inc.

Funding

Natera, Inc.

Disclosure

P.M. Kasi: Advisory/Consultancy: Natera, Inc.; Advisory/Consultancy: Foundation Medicine; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Taiho Pharmaceutical; Research grant/Funding (institution): Advanced Accelerator Applications; Research grant/Funding (institution): Array Biopharma; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Celgene. S. Sawyer, J. Guilford, M. Munro, S. Ellers, N. Hook, S. Krinshpun: Shareholder/Stockholder/Stock options, Full/Part-time employment: Natera, Inc. S. Moshkevich: Leadership role, Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment, Officer/Board of Directors: Natera, Inc.. P.R. Billings: Leadership role, Shareholder/Stockholder/Stock options, Full/Part-time employment: Natera, Inc.; Officer/Board of Directors: OmniSeq; Officer/Board of Directors: Mission Bio. A. Aleshin: Leadership role, Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Natera, Inc.; Advisory/Consultancy: Mission Bio; Advisory/Consultancy: Notable Labs.

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