UNITE: investigating biomarkers of response to enfortumab vedotin in patients with advanced UC

Tanya Jindal, BS, BA, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, shares the results of the retrospective UNITE study assessing biomarkers of response to enfortumab vedotin (EV) in patients with advanced urothelial carcinoma. Patients were included from 16 sites with available next generation sequencing using institutional or commercial platforms, treated with EV alone outside clinical trials. Observed response (ORR) was determined by investigators for evaluable ptients with scans after ≥1 dose of EV. Assessed molecular biomarkers included tumor mutation burden (TMB), PD-L1 status, somatic alterations (alts) in ≥ 10% of pts (TERTp, TP53, ARID1A, CDKN2A, CDKN2B, FGFR3, ERBB2, CCND1, KDM6A, MTAP, PIK3CA, RB1, TSC1) and presence of ≥1 DNA damage response mutations (ATM, BARD1, BRCA1, BRCA2, CDK12, CHEK2, PALB2, PPP2R2A, or RAD51B). A total of 170 patients had outcomes and NGS data available. For all patients, ORR 47%, median progression-free survival (mPFS) was 6 months, median overall-survival (OS) was 12 months. ORRs were higher in patients with ERBB2 and TSC1 alterations versus wild-type, although these results did not translate to OS or PFS. However, shorter mPFS was noted in patients with CDKN2A, CDKN2B, and MTAP alterations, while longer median OS in patients with high TMB. This interview took place at the ASCO GU Cancers Symposium 2023 in San Francisco, CA.

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