Abstract 2724
Background
Delta-like protein 3 (DLL3) is a transmembrane protein that is implicated in the tumorigenesis of small cell lung cancer (SCLC). The ability to quantify DLL3 protein may be useful to select patients that may be responsive to DLL3-targeted therapies; thus, the VENTANA DLL3 (SP347) Assay was developed for this purpose. Here, we present data on the robustness of the VENTANA DLL3 (SP347) Assay in SCLC.
Methods
Formalin-fixed, paraffin-embedded (FFPE) SCLC resection and biopsy specimens were used in a series of studies addressing robustness. These samples were stained with the VENTANA DLL3 (SP347) Assay and assessed by pathologists for percent tumor cell staining (%TC) at ≤ 4X magnification at any stain intensity. The %TC scores were stratified into bins (0-24, 25-49, 50-74 and 75-100 %TC) and assessed for precision across different antibody and detection kit lots, replicates, days, instruments, and platforms. For each case, the modal staining result based on %TC bin was determined and the result from each test sample was compared to its respective case-level modal staining result and deemed concordant or discordant. Results were aggregated across cases and the overall percent agreement (OPA) was calculated for each study.
Results
All studies (Table) showed >90% OPA for concordance to the %TC bins.Table: 1678P
Precision across lots, replicates, days, instruments, and platforms
| Study | # of Cases | # DLL3 Observations | OPA |
|---|---|---|---|
| Intra-day | 10 | 50 | 100.0% |
| Inter-day | 10 | 100 | 94.0% |
| Inter-antibody lot, inter-detection kit lot, and intra-platform | 24 | 648 | 95.8% |
| Intra-platform (GX) | 14 | 84 | 98.8% |
| Intra-platform (XT) | 14 | 84 | 97.6% |
| Intra-platform (ULTRA) | 14 | 84 | 98.8% |
| Inter-platform (GX, XT, and ULTRA) | 14 | 252 | 98.4% |
Conclusions
The data shows that the VENTANA DLL3 (SP347) Assay can precisely evaluate DLL3 expression in SCLC.
Clinical trial identification
Legal entity responsible for the study
Ventana Medical Systems, Inc.
Funding
Ventana Medical Systems, Inc.
Editorial Acknowledgement
Disclosure
C. Powell, E. Elgabry, B. Holmes, D. Tyree, R. Marati, B. Admire, T. Birdi, A.E. Hanlon Newell, D. Dalvi, R.S.P. Huang: Employee: Ventana Medical Systems, Inc./Roche.
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