The first targeted pill to lengthen survival in bladder cancer, for the fifth of tumours with FGFR alterations.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
266 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (cohort 1)primary | Erdafitinib | 136 | 12.1 months | 0.64 (0.47 to 0.88) | 0.005 | link |
| Chemotherapy | 130 | 7.8 months |
Shares FGFR3, FGFR3 alterations (bladder cancer), Erdafitinib, Bladder & urothelial cancer.
Shares Erdafitinib, Johnson & Johnson, Bladder & urothelial cancer, Small-molecule kinase inhibitors.
Shares Erdafitinib, Johnson & Johnson, Bladder & urothelial cancer, Small-molecule kinase inhibitors.
Shares Erdafitinib, Johnson & Johnson, Bladder & urothelial cancer, Small-molecule kinase inhibitors.
Shares FGFR2, Bladder & urothelial cancer, Small-molecule kinase inhibitors.
Shares FGFR2, Johnson & Johnson, Bladder & urothelial cancer.
Shares FGFR2, Bladder & urothelial cancer, Small-molecule kinase inhibitors.