ArticleFrontiers in immunology2026
Real-world safety of first-line enfortumab vedotin plus pembrolizumab in advanced urothelial carcinoma: evidence from VigiBase and FAERS.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Compared with platinum-based chemotherapy, the combination of enfortumab vedotin and pembrolizumab (EV + Pembro) achieves higher durable response rates and improves survival outcomes in patients with locally advanced or metastatic urothelial carcinoma. As the first regimen pairing an immune checkpoint inhibitor with an antibody-drug conjugate, it offers a novel, effective option. Yet evidence has largely been derived from clinical trials, and robust, comprehensive real-world characterization of adverse drug events (ADEs) remains limited. It is therefore essential to examine recent real-world data to delineate the safety profile of EV + Pembro with greater precision. Methods: We conducted disproportionality analyses of ADE reports related to EV + Pembro from the FDA Adverse Event Reporting System (FAERS) and the WHO VigiBase. Signal detection algorithms, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN), were used to identify significant safety signals. Additionally, the time to onset of ADEs was assessed. Results: A total of 892 reports from VigiBase and 1,698 reports from FAERS were analyzed across 25 system organ classes. Several previously unlisted ADEs in the product labeling were identified, such as dehydration, cholestasis, ileus, and tumor lysis syndrome. Subgroup analysis revealed that male patients were more prone to dehydration and renal impairment, while female patients were more likely to experience skin discoloration and alopecia. The median onset time for ADEs was 18 days, with males experiencing ADEs significantly earlier than females. Immune system disorders had the shortest median onset time, while surgical and medical procedures had the longest. Conclusion: This real-world analysis confirms known adverse reactions and identifies new safety signals for EV + Pembro. It also highlights differential risk profiles across subgroups, providing valuable insights for clinical practice. Further research is needed to validate these findings and refine patient management strategies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.