Enfortumab Vedotin in Patients With Previously Treated Advanced Breast Cancer in the Phase II EV-202 Study
Bibliographic record
Abstract
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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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".