Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2026
Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic Urothelial Carcinoma and
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The trial behind it
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Who cites it
8 citing papers in PubMed.
- Targeting cancer-associated fibroblasts: therapeutic strategies, translational challenges, and future perspectives.Journal of hematology & oncology · 2026Review
- Integrative multi-omics and single-cell analysis identifies EGFR pathway activation and metabolic reprogramming as potential synthetic lethal vulnerabilities in resistance to the FGFR inhibitor AZD4547.Journal of translational medicine · 2026Article
- Incidence and outcomes of FGFR inhibitor-associated retinopathy of patients treated with oral erdafitinib across the clinical trial program.The oncologist · 2026Article
- Multi-tyrosine kinase inhibitors: exploring immunomodulatory effects on various immune cell types in cancer.Cancer cell international · 2026Review
- Review
- FGFR signaling and apoptotic regulation in cancer: links to immune evasion, therapeutic resistance, and treatment re-engagement.Frontiers in immunology · 2026Review
- Efficacy of erdafitinib before or after enfortumab vedotin in FGFR3-altered advanced urothelial cancer: analysis of the UNITE collaborative study.The oncologist · 2025Article
- A phase 1/1b, open-label, dose-escalation study of PD-1 inhibitor, cetrelimab alone and in combination with FGFR inhibitor, erdafitinib in Japanese patients with advanced solid tumors.Investigational new drugs · 2024Article
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeFirst-line treatment options for cisplatin-ineligible patients with metastatic urothelial cancer (mUC) are limited. We conducted a phase II study of erdafitinib, alone or with cetrelimab, in
methodsAdults with mUC and select
resultsAt data cutoff, 87 patients were randomly assigned and treated (erdafitinib, n = 43; erdafitinib plus cetrelimab, n = 44). Of 64 patients with PD-L1 expression data, 56 (87.5%) had low levels of PD-L1 expression (combined positive score <10). Median survival follow-up was 14.2 months. Investigator-assessed confirmed ORR for erdafitinib was 44.2% (95% CI, 29.1 to 60.1) with one complete response (CR); median DOR and median OS were 9.7 months (95% CI, 4.6 to not estimable [NE]) and 16.2 months (95% CI, 8.3 to NE), respectively. Investigator-assessed confirmed ORR for erdafitinib plus cetrelimab was 54.5% (95% CI, 38.8 to 69.6), with six (13.6%) CRs; median DOR and median OS were 11.1 months (95% CI, 8.8 to NE) and 20.8 months (95% CI, 12.0 to NE), respectively. The most frequent treatment-related adverse events (TRAEs) were hyperphosphatemia (83.7% and 68.2% in erdafitinib and erdafitinib plus cetrelimab groups, respectively), stomatitis (69.8% and 56.8%), and dry mouth (37.2% and 56.8%). Grade ≥3 TRAEs occurred in 46.5% and 45.5% of patients receiving erdafitinib and erdafitinib plus cetrelimab, respectively.
conclusionFirst-line erdafitinib monotherapy and erdafitinib plus cetrelimab demonstrated antitumor activity and a manageable safety profile in cisplatin-ineligible patients with mUC.
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