Download NEXT-2_Trial - Guardant Health

First prospective clinical outcome trial using
comprehensive liquid biopsy demonstrates comparable
results to tissue-based testing
Highlights of the study
Researchers at Samsung Medical Center tracked the treatment outcomes of 193 advanced cancer
patients whose therapy was selected based solely on Guardant360® findings. It was the first prospective
clinical trial to evaluate how the use of a comprehensive liquid biopsy to guide therapy affects treatment
outcomes. It demonstrated that patients in whom Guardant360 identified an actionable alteration
responded to targeted therapy at rates comparable to or better than in the literature.1,2,3
Lung and gastric cancers constituted the majority of patients tested in the trial (78%). Patients showed
high response rates to matched therapy, both in lung (88%) and gastric (60%) cancers, demonstrating
comparable results to tissue-based testing. These results were presented at the 2016 American Society
of Clinical Oncology Annual Meeting by Dr. Jeeyun Lee of the Samsung Medical Center in a scientific
poster titled “The NEXT-2 (Next generation pErsonalized tX with plasma DNA Genomics Trial-2) in
refractory solid tumors: cfDNA-based umbrella trial, an interim analysis.”
NEXT-2 study cohort
Gastric Cancer
(N*=78)
NSCLC
(N*=72)
ctDNA Matched
Therapies (n)
10
17
Therapeutic Targets
ERBB2 amp (6)
PIK3CA mutation (2)
FGFR2 amp (1)
MET amp (1)
EGFR mutation (8)
EGFR T790M mutation (8)
EML4-ALK fusion (1)
Response Rate
(PR and CR)
60%
88%
Disease Control Rate
(PR, CR, SD)
90%
94%
*Number of total patients
PR = Partial Response
CR = Complete Response
SD = Stable Disease
“When patients were guided to matched therapy based on Guardant360 ctDNA profiling, the
response rate was comparable to what we see when selection is based on tissue specimens.”
– Principal Investigator, Dr. Jeeyun Lee | Samsung Medical Center
For a copy of this poster, please contact your local Guardant Health Account Executive.
1
Janne PA, Yang JC, Kim DW, Planchard D, Ohe Y, Ramalingam SS, Ahn MJ, Kim SW, Su WC, Horn L, et al. AZD9291 in EGFR inhibitor-resistant non-small-cell
lung cancer. N Engl J Med. 2015;372(18):1689–99.
2
Rosell R, Moran T, Queralt C, et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009;361. DOI: 10.1056/NEJMoa0904554.
3
Shaw AT, Kim DW, Nakagawa K, Seto T, Crino L, Ahn MJ, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med.
2013;368(25):2385–94.
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