# THOR

Source: https://onco.cc/trials/thor/  
OnCo record `thor` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first targeted pill to lengthen survival in bladder cancer, for the fifth of tumours with FGFR alterations.

## Summary

THOR, trial NCT03390504 sponsored by Johnson & Johnson and reported in 2023, produced the first targeted tablet to lengthen survival in bladder cancer, for the fifth of advanced urothelial tumours with FGFR alterations. Cohort 1 randomised 266 patients with FGFR3 or FGFR2 alterations after chemotherapy and a checkpoint inhibitor to erdafitinib or chemotherapy and met its primary overall survival endpoint with a clear benefit, while cohort 2, against pembrolizumab in immunotherapy-naive patients, showed no benefit, so erdafitinib is positioned after immunotherapy; full FDA approval followed in January 2024. OnCo links it to bladder cancer, FGFR2 as a target, erdafitinib and the FGFR3 alterations term, and THOR-2 explored intravesical and oral use in non-muscle-invasive disease. Whether FGFR inhibitors can be combined with immunotherapy rather than sequenced after it is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03390504
- Phase: 3
- Setting: Advanced urothelial cancer with FGFR3/2 alterations after chemotherapy and a checkpoint inhibitor: erdafitinib vs chemotherapy (cohort 1)
- Sponsor: Johnson & Johnson
- Enrolled: 266
- Result: OS 12.1 vs 7.8 months, HR 0.64 (cohort 1).
- Outcomes: Overall survival (cohort 1): Erdafitinib 12.1 months vs Chemotherapy 7.8 months, HR 0.64
- Replication: Cohort 2 (vs pembrolizumab) negative; benefit confined to the post-IO setting.

## Sources

- ClinicalTrials.gov NCT03390504: https://clinicaltrials.gov/study/NCT03390504

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [FGFR2](https://onco.cc/targets/fgfr2/), [FGFR3](https://onco.cc/targets/fgfr3-receptor/)
- drugs: [Erdafitinib](https://onco.cc/drugs/erdafitinib/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- terms: [FGFR3 alterations (bladder cancer)](https://onco.cc/terms/fgfr3/)

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JSON: https://onco.cc/api/v1/entities/thor.json