Bibliographic Details
| Title: |
Pan-tumor validation of a NGS fraction-based MSI analysis as a predictor of response to Pembrolizumab. |
| Authors: |
Lin, Douglas I., Quintanilha, Julia C. F., Danziger, Natalie, Lang, Lixin, Levitan, Diane, Hayne, Cynthia, Hiemenz, Matthew C., Smith, David L., Albacker, Lee A., Leibowitz, Jeffrey, Mata, Douglas A., Decker, Brennan, Lakis, Sotirios, Patel, Nimesh R., Graf, Ryon P., Elvin, Julia A., Ross, Jeffrey S., Pattani, Varun, Huang, Richard S. P., Wehn, Amy K. |
| Source: |
NPJ Precision Oncology; 9/14/2024, Vol. 8 Issue 1, p1-9, 9p |
| Subject Terms: |
TREATMENT effectiveness, NUCLEOTIDE sequencing, TUMOR treatment, DATABASES, MICROSATELLITE repeats |
| Abstract: |
Microsatellite instability high (MSI-H) and mismatch repair deficient (dMMR) tumor status have been demonstrated to predict patient response to immunotherapies. We developed and validated a next-generation sequencing (NGS)-based companion diagnostic (CDx) to detect MSI-H solid tumors via a comprehensive genomic profiling (CGP) assay, FoundationOne®CDx (F1CDx). To determine MSI status, F1CDx calculates the fraction of unstable microsatellite loci across >2000 loci using a fraction-based (FB) analysis. Across solid tumor types, F1CDx demonstrated a high analytical concordance with both PCR (n = 264) and IHC (n = 279) with an overall percent agreement (OPA) of 97.7% and 97.8%, respectively. As part of a retrospective bridging clinical study from KEYNOTE-158 Cohort K and KEYNOTE-164, patients with MSI-H tumors as determined by F1CDx demonstrated an objective response rate (ORR) of 43.0% to pembrolizumab. In real-world cancer patients from a deidentified clinicogenomic database, F1CDx was at least equivalent in assessing clinical outcome following immunotherapy compared with MMR IHC. Demonstrated analytical and clinical performance of F1CDx led to the pan-tumor FDA approval in 2022 of F1CDx to identify MSI-H solid tumor patients for treatment with pembrolizumab. F1CDx is an accurate, reliable, and FDA-approved method for the identification of MSI-H tumors for treatment with pembrolizumab. [ABSTRACT FROM AUTHOR] |
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| Database: |
Complementary Index |
