THOR
The first targeted pill to lengthen survival in bladder cancer, for the fifth of tumours with FGFR alterations.
Cohort 1: OS 12.1 vs 7.8 months (HR 0.64); PFS 5.6 vs 2.7. Cohort 2 (vs pembrolizumab in IO-naive patients) showed no benefit, so erdafitinib is positioned after immunotherapy. Full FDA approval January 2024. THOR-2 explored intravesical/oral use in NMIBC.
Setting
Advanced urothelial cancer with FGFR3/2 alterations after chemotherapy and a checkpoint inhibitor: erdafitinib vs chemotherapy (cohort 1)
Phase
Phase 3
Sponsor
Johnson & Johnson
Registry
Headline result
OS 12.1 vs 7.8 months, HR 0.64 (cohort 1).
Reported
2023
Enrolled
266
Replication
Cohort 2 (vs pembrolizumab) negative; benefit confined to the post-IO setting.
In plain words
What these results mean for people, not percentages
Overall survival (cohort 1)primarysurvival endpoint
- Median 12.1 vs 7.8 months with Erdafitinib compared with Chemotherapy; about 4.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 36 percent lower chance of the event at any given time (hazard ratio 0.64, likely range 0.47 to 0.88).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Advanced urothelial cancer with FGFR3/2 alterations after chemotherapy and a checkpoint inhibitor: erdafitinib vs chemotherapy (cohort 1). People in a different situation may not see the same effect.
- The trial selected people by a biomarker (FGFR3); the result should not be assumed for people whose cancer does not have it.
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 participants enrolled.
Overall survival (cohort 1)primary
HR 0.64 (0.47–0.88) · p = 0.005
Erdafitinib
12.1 mo
Chemotherapy
7.8 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (cohort 1)primary | Erdafitinib | 136 | 12.1 months | 0.64 (0.47–0.88) | 0.005 | link |
| Chemotherapy | 130 | 7.8 months |
Replication
Cohort 2 (vs pembrolizumab) negative; benefit confined to the post-IO setting.Pages like this
not linked directly; found by shared links- CompanyJohnson & Johnson
Shares Erdafitinib, Bladder & urothelial cancer.