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Published on: September 25, 2018
International real-world study of DLL3 expression in patients with small cell lung cancer
Federico Rojo1, Marcelo Corassa2, Dimitrios Mavroudis3
1Hospital Universitario Fundación Jiménez Díaz CIBERONC, Madrid, Spain.
Objectives:
Expression of the Notch-family ligand delta-like protein 3 (DLL3), a potential therapeutic target in small cell lung cancer (SCLC), has not been assessed in the real-world setting. To identify the real-world utility of DLL3 as an SCLC therapeutic target, we performed the largest retrospective international noninterventional study to date to evaluate DLL3 prevalence in SCLC patients.
Materials And Methods:
DLL3 expression was assessed using immunohistochemistry in archived histological and cytological specimens (independent and paired) and correlated to patient demographics, clinical disease characteristics, and survival. The primary endpoint was the proportion of patients with DLL3 expression in ≥25 % of tumor cells. DLL3 expression concordance was assessed in paired specimens.
Results:
Independent tumor specimens were collected from 1073 patients. The mean age at biopsy was 66 years (SD, 10); 682 (64 %) patients were male. Paired specimens were collected from 36 patients. The mean age at biopsy was 62 years (SD, 11); 16 (44 %) patients were male. Most patients had ECOG performance status of 0-1, were smokers/ex-smokers, and received ≥1 prior therapy. Positive DLL3 expression (defined as ≥25 % of tumor cells) was identified in 895/1050 (85 %) patients with 1 specimen and evaluable DLL3 expression; 719/1050 (68 %) patients had high DLL3 expression (defined as ≥75 % of tumor cells). DLL3 expression concordance was 88 % between paired specimens (n = 17; Cohen's kappa P value, .9412). There was no significant difference in median overall survival from SCLC diagnosis for evaluable patients with nonmissing data based on DLL3 expression (negative DLL3 expression [n = 139], 9.5 months; positive DLL3 expression [n = 747], 9.5 months; all evaluable patients [n = 893, 9.5 months).
Conclusion:
These real-world epidemiologic findings indicate that DLL3 is robustly expressed across SCLC disease stages and remains stable despite treatment, consistent with available clinical trial data. There was no prognostic role for DLL3 observed in this study for overall survival.
Insights
Delta-like protein 3 (DLL3) is highly expressed in most small cell lung cancer (SCLC) patients, regardless of disease stage or treatment. This real-world study found no significant impact of DLL3 expression on patient survival.
Area of Science:
- Oncology
- Molecular Biology
- Clinical Research
Background:
- Delta-like protein 3 (DLL3) is a potential therapeutic target in small cell lung cancer (SCLC).
- Real-world data on DLL3 expression prevalence in SCLC is limited.
- Understanding DLL3 expression is crucial for evaluating its therapeutic utility.
Purpose of the Study:
- To assess the real-world prevalence of DLL3 expression in a large cohort of SCLC patients.
- To evaluate the concordance of DLL3 expression in paired tumor specimens.
- To correlate DLL3 expression with patient demographics, clinical characteristics, and survival outcomes.
Main Methods:
- Retrospective, international, noninterventional study.
- Immunohistochemistry used to assess DLL3 expression in archived histological and cytological specimens.
- Analysis of 1073 independent and 36 paired SCLC tumor specimens.
- Correlation with patient data and survival analysis.
Main Results:
- DLL3 expression (≥25% tumor cells) was found in 85% of evaluable SCLC patients.
- High DLL3 expression (≥75% tumor cells) was observed in 68% of patients.
- DLL3 expression concordance between paired specimens was high (88%).
- No significant difference in median overall survival was observed based on DLL3 expression levels.
Conclusions:
- DLL3 is robustly expressed across SCLC disease stages and remains stable despite treatment.
- Real-world findings are consistent with existing clinical trial data.
- DLL3 expression did not demonstrate a prognostic role for overall survival in this study.
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