drugset / Trial / NCT03390504

A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

Phase 3 Active not recruiting 629 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-\[L\]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).

Timeline

Start: 2018-03-23
Primary completion: 2024-04-15
Completion: 2027-12-31

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg vs Cohort 1: Arm 1B: Chemotherapy reads as mixed primary results NCT03390504 ↗

registry p =0.0031; Hazard Ratio (HR) 0.65 (95% CI 0.48 to 0.86); Log Rank reads as mixed primary results NCT03390504 ↗

registry Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg vs Cohort 2: Arm 2B: Pembrolizumab 200 mg reads as mixed primary results NCT03390504 ↗

registry p =0.2121; Hazard Ratio (HR) 1.16 (95% CI 0.92 to 1.48); Stratified log-rank test reads as mixed primary results NCT03390504 ↗

release “Phase 3 THOR study (NCT03390504), evaluating the efficacy and safety of erdafitinib versus chemotherapy.9The study met its primary endpoint of overall survival (OS)” reads as met primary endpoint jnj.com ↗

release “results from Cohort 1 of the Phase 3 THOR study, which showed a 36 percent reduction in the risk of death with erdafitinib versus chemotherapy” reads as met primary endpoint jnj.com ↗

Publications

Loriot Y, Matsubara N, Park SH, Huddart RA, Burgess EF, Houede N, Banek S, Guadalupi V, Ku JH, Valderrama BP, Tran B, Triantos S, Kean Y, Akapame S, Deprince K, Mukhopadhyay S, Stone NL, Siefker-Radtke AO; THOR Cohort 1 Investigators. Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2023 Nov 23;389(21):1961-1971. doi: 10.1056/NEJMoa2308849. Epub 2023 Oct 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Erdafitinib	Small molecule	8 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Vinflunine	Small molecule	320 mg/m2	Intravenous