Abstract 1430P
Background
In patients with advanced non-small cell lung cancer (aNSCLC) timely therapeutic decision making is critical. In the past decade the treatment options for aNSCLC have expanded, along increased numbers of biomarkers that need to be tested, often on small and sparse material with multiple testing technologies. This may result in an undesired prolonged time to treatment and in the worst case even to non-feasible analysis. To elucidate the performance of the Idylla™ GeneFusion Assay, which simultaneously covers the biomarkers ALK, ROS1, RET and MET exon 14 skipping, a multicenter study was conducted in a routine clinical setting involving 12 clinical centers across Europe.
Methods
A total of 326 archival aNSCLC formalin fixed paraffin embedded (FFPE) samples were included. The results of the Idylla™ GeneFusion Assay were compared with the biomarker status determined earlier with routine reference methods (including FISH, IHC, RT-PCR, and NGS). A total of 179 biomarker positive cases (85 ALK, 33 ROS1, 20 RET and 41 MET exon 14 skipping) were included, making this one of the largest fusion positive datasets tested. The Idylla™ detects ALK, ROS1 and RET fusions using both fusion specific and expression imbalance detection, allowing for the detection of less common fusions not covered by the fusion specific PCR’s.
Results
FFPE sample types used were 44% resected specimen, 46% tissue biopsies, 9% cytological specimen and 1% unknown. 67% of the centers used only 1 or 2 FFPE sections (5 or 10μm). The Idylla™ GeneFusion Assay demonstrated a low failure rate (0.9%). It showed also a high sensitivity/specificity, respectively for the following actionable biomarkers in NSCLC: 96.1%/99.6% for ALK, 96.5%/98.9% for ROS1, 100%/99.6% for RET and 92.5%/100% for MET exon 14 skipping.
Conclusions
Since results are available within 3 hours, the Idylla™ GeneFusion Assay technology has emerged as a highly relevant time efficient upfront screening tool in FFPE samples. Moreover, detection of potentially novel fusions based on the principle of expression imbalance may be easily verified with either IHC, FISH or NGS without delaying the treatment initiation.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Biocartis NV.
Funding
Biocartis.
Disclosure
A. Hartmann, A. Hirschmann, P. Hofman, A. Concha, S. Mrabet-Dahbi, P. Vannuffel, E. Watkin, M. Putzova, S. Scarpino, A. Cayre, P. Martin, L.C. Melchior: Other, Institutional, Part of this industry sponsored study (Biocartis NV): Biocartis.
Resources from the same session
1368P - LUMINATE 102: A real-world study on biomarker testing rates among patients with non-small cell lung cancer (NSCLC) across lines of therapy
Presenter: Charu Aggarwal
Session: Poster session 20
1369P - BrigAlec study: Focus on alectinib efficacy after brigatinib exposure in BrigALK2 study (GFPC 02-2019)
Presenter: Renaud Descourt
Session: Poster session 20
1370P - Efficacy and safety of ensartinib in ALK-positive non-small cell lung cancer patients with brain metastases: A multicenter, open-label, single-arm, phase II study
Presenter: Jianhua Chang
Session: Poster session 20
1371P - First-line alectinib vs. brigatinib in advanced metastatic NSCLC with ALK rearrangement: Real-world data
Presenter: Young Kyung Jeon
Session: Poster session 20
1372P - Repotrectinib in patients (pts) with NTRK fusion-positive (NTRK+) advanced solid tumors, including NSCLC: Update from the phase I/II TRIDENT-1 trial
Presenter: Ben Solomon
Session: Poster session 20
1373P - Efficacy and safety of taletrectinib in patients (Pts) with ROS1+ non-small cell lung cancer (NSCLC): Interim analysis of global TRUST-II study
Presenter: Maurice Pérol
Session: Poster session 20
1374P - Survival and therapy analysis of small-scale ROS1-mutant non-small cell lung cancer (NSCLC) patients
Presenter: Moritz Glaser
Session: Poster session 20
1375P - Beamion Lung 1, an ongoing phase Ia/Ib trial of the HER2 TKI, BI 1810631 in patients (pts) with advanced solid tumors with HER2 aberrations: Latest data
Presenter: Frans Opdam
Session: Poster session 20
1377P - Differential impact of EGFR exon 20 insertion location on tyrosine kinase inhibitor sensitivity
Presenter: Xiuning Le
Session: Poster session 20
1378P - Efficacy and safety of tunlametinib (HL-085) combined with vemurafenib in patients with advanced BRAF V600-mutated solid tumors: A multicenter, phase I study
Presenter: Yuan-Kai Shi
Session: Poster session 20