Enfortumab Vedotin in Patients With Previously Treated Advanced Breast Cancer in the Phase II EV-202 Study

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PURPOSE EV-202 (ClinicalTrials.gov identifier: NCT04225117 ) evaluated enfortumab vedotin (EV), a nectin-4–directed antibody-drug conjugate, in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2−) and triple-negative breast cancer (TNBC). METHODS This open-label, multicohort, Phase II study included eligible adults with locally advanced or metastatic (la/m) BC who had progressed, relapsed, or discontinued for toxicity during or after ≥1 previous standard-of-care cytotoxic regimen in the incurable, unresectable la/m setting, and had not received >2 previous lines of cytotoxic therapy in the la/m setting. Patients had received previous endocrine treatment (HR+/HER2−) or PD-1/L1 inhibitor if eligible (TNBC). Patients received EV 1.25 mg/kg intravenously on days 1, 8, and 15 of 28-day cycles. The primary end point was investigator-assessed confirmed objective response rate (ORR) per RECIST v1.1. Secondary end points included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. RESULTS Forty-five women with HR+/HER2− BC received EV. Confirmed ORR and DCR were 15.6% and 51.1%, respectively. Median DOR, PFS, and OS were 7.23, 5.39, and 19.75 months, respectively. Twenty patients experienced grade ≥3 treatment-related adverse events (TRAEs), most commonly, rash maculopapular (n = 7, 16%), pruritus, and increased AST (both n = 3, 7%). Forty-two women with TNBC received EV. Confirmed ORR and DCR were 19.0% and 57.1%, respectively. Median DOR, PFS, and OS were 3.78, 3.52, and 12.91 months, respectively. Twelve patients experienced grade ≥3 TRAEs, most commonly, decreased neutrophil count (n = 3, 7%). CONCLUSION Although EV showed antitumor activity in heavily pretreated HR+/HER2− BC and TNBC, efficacy did not meet the prespecified threshold. The safety profile was consistent with previous reports. A trend was not observed between nectin-4 and patient response.

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