EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
Bibliographic record
Abstract
4571 Background: EV-302/KEYNOTE-A39 (NCT04223856) demonstrated superior efficacy of first-line (1L) EV+P vs chemo and established EV+P as the standard of care (SOC). EV+P is included in global treatment guidelines for patients (pts) with untreated la/mUC. After ≈2.5 years of median follow-up, the benefit of EV+P was sustained; median OS was maintained for > 2.5 years. We present long-term efficacy and safety analyses in the following prespecified subgroups: primary disease site of origin (upper and lower tracts), lymph node (LN)–only disease, and presence of liver metastases (mets) (present and absent). Methods: Pts with previously untreated la/mUC were randomized 1:1 to receive EV (1.25 mg/kg; Days 1 and 8; IV) and P (200 mg; Day 1; IV) or chemo (gemcitabine with cisplatin or carboplatin) every 3 wk. Primary endpoints were progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS). A genAI tool (01/09/25; Pfizer; GPT-4o) developed the 1 st draft; authors assume content responsibility. Results: Pts (N = 886) were randomized to receive EV+P (n = 442) or chemo (n = 444) and were analyzed according to the subgroups shown in the Table. At data cutoff (Aug 8, 2024), median follow-up was 29.1 mo (95% CI, 28.5-29.9). PFS by BICR, OS, duration of response, and objective response rate continued to demonstrate sustained benefit of EV+P vs chemo across prespecified subgroups after long-term follow-up (Table). For EV+P, treatment-related adverse events (TRAEs) occurred in 96.0-98.5% and Grade ≥3 TRAEs in 53.4-60.7% of pts across prespecified subgroups, generally consistent with previous reports. Conclusions: EV+P continues to demonstrate superior long-term efficacy vs chemo in key subgroups with both favorable and poor prognoses. There were no new safety signals, and AE rates in prespecified subgroups were consistent with the overall population after an additional year of follow-up. This reinforces EV+P as the SOC for the 1L treatment of pts with la/mUC. Clinical trial information: NCT04223856 . Upper tract Lower tract LN only Liver mets present Liver mets absent EV+P, n (%) 135 (30.5) 305 (69.0) 103 (23.3) 100 (22.6) 342 (77.4) Chemo, n (%) 104 (23.4) 339 (76.4) 104 (23.4) 99 (22.3) 345 (77.7) mPFS, moEV+P 12.3 12.8 22.1 8.1 16.4 Chemo 6.2 6.3 8.3 6.0 6.4 PFS HR (95% CI) 0.542 (0.384-0.763) 0.462(0.379-0.564) 0.473 (0.317-0.704) 0.548 (0.392-0.766) 0.458 (0.376-0.557) mOS, moEV+P 36.5 32.9 NR 19.1 39.3 Chemo 18.3 15.6 24.4 10.1 18.3 OS HR(95% CI) 0.538 (0.371-0.781) 0.504 (0.408-0.623) 0.512 (0.332-0.789) 0.556 (0.399-0.776) 0.496 (0.400-0.615)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.007 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".