BLC2001
Erdafitinib in locally advanced or metastatic urothelial carcinoma with prespecified FGFR alterations (BLC2001)
Phase 2NCT02365597
- Population
- Locally advanced and unresectable or metastatic urothelial carcinoma with prespecified FGFR alterations and prior chemotherapy; prior immunotherapy allowed
- Design
- Open-label phase 2 study in patients with prespecified FGFR alterations and progression during or after at least one chemotherapy course (or within 12 months of neoadjuvant or adjuvant chemotherapy). Patients were first randomised to intermittent or continuous erdafitinib; the selected regimen was 8 mg per day continuous with pharmacodynamically guided escalation to 9 mg. Primary endpoint objective response rate.
- Primary endpoint
- ORR
- Arms
- Selected regimen (8 mg continuous, escalation to 9 mg) (experimental, n = 99): Erdafitinib 8 mg per day continuous, pharmacodynamically guided escalation to 9 mg
- People
- Loriot Y
Show the numbers
| Endpoint | Analysis | Selected regimen (8 mg continuous, escalation to 9 mg) | Control | Effect |
|---|---|---|---|---|
| ORRSelected-regimen group (n = 99) | primaryLoriot 2019 | 40% | — | 3% complete responses and 37% partial responses; the abstract gives no confidence interval. |
| ORRSelected-regimen patients with previous immunotherapy (n = 22) | primaryLoriot 2019 | 59% | — | — |
| PFSSelected-regimen group (n = 99) | primaryLoriot 2019 | median 5.5 months | — | — |
| OSSelected-regimen group (n = 99) | primaryLoriot 2019 | median 13.8 months | — | — |
| Endpoint | Analysis | Selected regimen (8 mg continuous, escalation to 9 mg) | Control | Effect |
|---|---|---|---|---|
| ORRSelected-regimen group (n = 99) | primaryLoriot 2019 | 40% | — | 3% complete responses and 37% partial responses; the abstract gives no confidence interval. |
| ORRSelected-regimen patients with previous immunotherapy (n = 22) | primaryLoriot 2019 | 59% | — | — |
| PFSSelected-regimen group (n = 99) | primaryLoriot 2019 | median 5.5 months | — | — |
| OSSelected-regimen group (n = 99) | primaryLoriot 2019 | median 13.8 months | — | — |
- Selected regimen (8 mg continuous, escalation to 9 mg) (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Selected regimen (8 mg continuous, escalation to 9 mg) |
|---|---|
| 0 | 100.0% |
| 3 | 68.5% |
| 7 | 41.4% |
| 10 | 28.4% |
| 14 | 17.1% |
- Selected regimen (8 mg continuous, escalation to 9 mg) (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Selected regimen (8 mg continuous, escalation to 9 mg) |
|---|---|
| 0 | 100.0% |
| 9 | 63.6% |
| 17 | 42.6% |
| 26 | 27.1% |
| 35 | 17.2% |