A Phase 3 study (NCT03390504) evaluating erdafitinib compared with pembrolizumab or chemotherapy in participants with advanced urothelial cancer completed its primary data collection on 2024-04-15. The trial's Cohort 2, which compared erdafitinib to pembrolizumab, showed erdafitinib with a median progression-free survival (PFS) of 4.44 months versus 2.69 months for pembrolizumab, and an objective response rate (ORR) of 40.0% versus 21.6%, respectively.
Background
The study investigated erdafitinib against chemotherapy (vinflunine or docetaxel) or pembrolizumab in participants with advanced urothelial cancer. These participants harbored selected fibroblast growth factor receptor (FGFR) gene aberrations. The trial focused on patients who had progressed after one or two prior treatments, with specific criteria for prior anti-programmed death ligand 1 (PD-[L]1) agent exposure.
Trial design
The Phase 3 study (NCT03390504) enrolled 629 participants with urothelial cancer. The trial was designed with two cohorts. Cohort 1 evaluated erdafitinib (8 mg/9 mg) against chemotherapy (vinflunine 320 mg/m^2 or docetaxel 75 mg/m^2) in participants who had progressed after one or two prior treatments, at least one of which included an anti-PD-(L)1 agent. Cohort 2 evaluated erdafitinib (8 mg/9 mg) against pembrolizumab (200 mg) in participants who had received one prior treatment not containing an anti-PD-(L)1 agent.
Key results
The trial reported key outcome measurements for overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
- Cohort 1 (Erdafitinib vs Chemotherapy):
- Median OS: Erdafitinib 12.06 Months vs Chemotherapy 8.74 Months.
- Median PFS: Erdafitinib 5.39 Months vs Chemotherapy 2.73 Months.
- ORR: Erdafitinib 46.9 Percentage of participants vs Chemotherapy 12.6 Percentage of participants.
- Cohort 2 (Erdafitinib vs Pembrolizumab):
- Median OS: Erdafitinib 10.91 Months vs Pembrolizumab 11.07 Months.
- Median PFS: Erdafitinib 4.44 Months vs Pembrolizumab 2.69 Months.
- ORR: Erdafitinib 40.0 Percentage of participants vs Pembrolizumab 21.6 Percentage of participants.
Key analyses included:
- For Cohort 1 (Erdafitinib vs Chemotherapy), a Log Rank analysis showed a Hazard Ratio (HR) of 0.65 (95% CI: 0.48, 0.86) with a p-value of 0.0031.
- For Cohort 2 (Erdafitinib vs Pembrolizumab), a Stratified log-rank test showed a Hazard Ratio (HR) of 1.16 (95% CI: 0.92, 1.48) with a p-value of 0.2121.
What this means
The results indicate that erdafitinib demonstrated superior efficacy compared to chemotherapy (vinflunine or docetaxel) in Cohort 1 for advanced urothelial cancer patients with FGFR aberrations who had received prior anti-PD-(L)1 agents, with a statistically significant improvement in overall survival, progression-free survival, and objective response rate. In Cohort 2, comparing erdafitinib to pembrolizumab, erdafitinib showed improved progression-free survival and objective response rate, although the overall survival benefit was not statistically significant. These findings suggest that erdafitinib could be a valuable treatment option for specific advanced urothelial cancer populations, particularly those with FGFR aberrations and prior treatment exposure.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03390504, titled "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", were posted on 2024-04-15 on clinicaltrials.gov.