Sysmex Inostics' OncoBEAM Platform Demonstrates Superior Detection of Clinically-relevant Mutations for Therapy Selection and Molecular Monitoring for Lung and Colon Cancers - Seite 2

Building on the proven high sensitivity of the OncoBEAM EGFR test, the LungBEAM study conducted by researchers at 19 different hospitals across Spain and led by Prof. Pilar Garrido sought to evaluate the clinical value of longitudinal EGFR plasma testing in tissue-confirmed advanced NSCLC patients during first-line EGFR TKI therapy. The timing of emergence of the T790M resistance mutation was examined, as well as the dynamics of EGFR sensitizing mutations (L858R and exon 19 deletions) compared to radiological progression. Out of 60 patients who completed the study and showed clinical or radiological progression, 20 (33%) exhibited T790M present in plasma; for 13 of these patients, T790M was detected an average of 14 weeks prior to radiological progression. It was also found that clearance of EGFR sensitizing mutations 8 weeks after initiation of EGFR TKI therapy correlated with increased progression-free survival (40.3 weeks with clearance vs. 25.8 weeks without) and may be a favorable clinical indicator of PFS that can be easily measured early during therapy administration.

Together, these studies reinforce how the exquisite sensitivity of the OncoBEAM platform which enables detection of the greatest number of positive patients overall can deliver unique clinical value. A highly sensitive assay is especially important for timely detection of mutations that can be monitored in real time as surrogate biomarkers of disease burden. "The demonstrated high sensitivity of OncoBEAM is ideal not only to maximize detection of known therapeutic indications, but also to explore potential clinical uses of ctDNA to monitor disease evolution at much higher resolution that is currently possible through radiographic imaging," commented Dr. Pilar Garrido, lead investigator for the LungBEAM study. "At a time when many different technologies and products are available for molecular oncology, it has become increasingly important for researchers and clinicians to select the best option to answer the specific question at hand."

Presentation Details (all times local)

• Saturday, October 20^th, 12:30, Biomarkers, 100P: Comparison of OncoBEAM and NGS methods to detect plasma EGFR T790M mutations at progression of NSCLC.
• Saturday, October 20^th, 12:30, Biomarkers, 121P: LungBEAM: A prospective multicenter trial to monitor EGFR mutations using BEAMing technology in Stage IV NSCLC patients.
• Sunday, October 21^st, 13:05, Gastrointestinal tumors - colorectal, 550P: Evaluation of the sensitivity of RAS mutation detection of the Idylla platform in comparison to the OncoBEAM RAS CRC assay.

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