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Thomas Flaig, MD


ASCO GU 2023: Predicting Outcomes With Enfortumab Vedotin in Advanced Urothelial Carcinoma

By: Julia Fiederlein Cipriano
Posted: Tuesday, February 21, 2023

According to Vadim S. Koshkin, MD, of the University of California, San Francisco, and colleagues, there are limited data regarding the biomarkers of response to the Nectin-4–directed antibody-drug conjugate enfortumab vedotin-ejfv in patients with advanced urothelial carcinoma. A retrospective analysis of data from the UNITE study, which was presented during the 2023 American Society for Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (Abstract 450), identified several potential candidates.

The investigators focused on 170 patients who underwent monotherapy with enfortumab vedotin outside of a clinical trial. Next-generation sequencing data were used to assess the tumor mutational burden, PD-L1 status, somatic alterations occurring in at least 10% of the population (TERT promotor, TP53, ARID1A, CDKN2A, CDKN2B, FGFR3, ERBB2, CCND1, KDM6A, MTAP, PIK3CA, RB1, and TSC1), and the presence of at least one DNA damage response mutation (ATM, BARD1, BRCA1, BRCA2, CDK12, CHEK2, PALB2, PPP2R2A, or RAD51B).

In all patients, the observed response rate was 47%; the median durations of progression-free and overall survival were 6 and 12 months, respectively. Patients with ERBB2 (67% vs. 44%; P = .05) and TSC1 (68% vs. 25%; P = .04) alterations experienced higher observed response rates than their wild-type counterparts. The median durations of progression-free survival were shorter in patients with CDKN2A (4.6 vs. 6.0 months; P = .02), CDKN2B (4.4 vs. 6.0 months; P < .01), and MTAP (4.6 vs. 6.0 months; P = .05) alterations; patients with high tumor mutational burden experienced a prolonged median duration of overall survival (13.6 vs. 8.3 months; P = .02).

“These findings, upon external validation, may help inform clinical decision-making and potential therapy sequencing with available antibody-drug conjugates,” the investigators concluded. “[The limitations of this analysis] include [its] retrospective nature, patient selection, and confounding biases.”

Disclosure: For full disclosures of the study authors, visit

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