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• W4365509849 abstract "<div>AbstractPurpose:<p>The antibody–drug conjugate enfortumab vedotin (EV) releases a cytotoxic agent into tumor cells via binding to the membrane receptor NECTIN-4. EV was recently approved for patients with metastatic urothelial carcinoma (mUC) without prior assessment of the tumor receptor status as ubiquitous NECTIN-4 expression is assumed. Our objective was to determine the prevalence of membranous NECTIN-4 protein expression in primary tumors (PRIM) and patient-matched distant metastases (MET).</p>Experimental Design:<p>Membranous NECTIN-4 protein expression was measured (H-score) by IHC in PRIM and corresponding MET (<i>N</i> = 137) and in a multicenter EV-treated cohort (<i>N</i> = 47). Progression-free survival (PFS) after initiation of EV treatment was assessed for the NECTIN-4–negative/weak (H-score 0–99) versus moderate/strong (H-score 100–300) subgroup. The specificity of the NECTIN-4 IHC staining protocol was validated by establishing CRISPR-Cas9–induced polyclonal NECTIN-4 knockouts.</p>Results:<p>In our cohort, membranous NECTIN-4 expression significantly decreased during metastatic spread (Wilcoxon matched pairs <i>P</i> < 0.001; median H-score = 40; interquartile range, 0–140), with 39.4% of MET lacking membranous NECTIN-4 expression. In our multicenter EV cohort, absence or weak membranous NECTIN-4 expression (34.0% of the cohort) was associated with a significantly shortened PFS on EV (log-rank <i>P</i> < 0.001).</p>Conclusions:<p>Membranous NECTIN-4 expression is frequently decreased or absent in mUC tissue. Of note, the clinical benefit of EV strongly depends on membranous NECTIN-4 expression. Thus, our results are of highest clinical relevance and argue for a critical reconsideration of the current practice and suggest that the NECTIN-4 receptor status should be determined (ideally in a metastatic/progressive lesion) before initiation of EV.</p><p><i><a href=https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-22-3882 target=_blank>See related commentary by Aggen et al., p. 1377</a></i></p></div>" @default.
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• W4365509849 date "2023-04-14" @default.
• W4365509849 modified "2023-09-27" @default.
• W4365509849 title "Data from Membranous NECTIN-4 Expression Frequently Decreases during Metastatic Spread of Urothelial Carcinoma and Is Associated with Enfortumab Vedotin Resistance" @default.
• W4365509849 doi "https://doi.org/10.1158/1078-0432.c.6532790.v2" @default.
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