KEY TAKEAWAYS
- The THOR phase III trial aimed to assess the efficacy and safety of erdafitinib compared to chemotherapy in FGFR-altered urothelial cancer Asian patients.
- The primary endpoint was OS.
- Erdafitinib mirrored its success in the overall THOR population within the Asian subgroup, demonstrating superior survival and response rates compared to chemotherapy while maintaining a similar safety profile.
Advanced urothelial cancer (la/mUC) offers limited treatment options after failed immunotherapy with anti-PD-L1 drugs. Erdafitinib, a targeted therapy, showed promise in a global study against chemotherapy for specific genetic mutations (FGFR alterations) in la/mUC patients who progressed after previous treatments, including anti-PD-L1 (cohort 1).
So, for this study, researchers aimed to assess the efficacy and safety of erdafitinib compared to chemotherapy in Asian patients with FGFR-altered urothelial cancer.
Patients in cohort 1 were randomly assigned to receive erdafitinib (8 mg once daily) or chemotherapy (vinflunine or docetaxel once every 3 weeks). The primary endpoint assessed was overall survival (OS).
About 76 patients (erdafitinib: 37; docetaxel: 39; vinflunine: 0) from China, Japan, Korea, and Taiwan were included in the analysis. Overall, 68% had received two prior lines of treatments, and 51% had their primary tumor in the upper urinary tract. The median follow-up was 15.7 months.
Erdafitinib demonstrated improved outcomes compared to chemotherapy, with median overall survival(OS 23.3 vs. 11.3 months), median progression-free survival(PFS5.6 vs. 2.7 months), and overall response rate (ORR 49 vs. 8%) favoring erdafitinib.
Grade 3/4 treatment-related adverse events (AEs) occurred in 41% of patients on erdafitinib and 58% on chemotherapy, with treatment-related discontinuations at 3% and 12%, respectively.
The results showed that erdafitinib mirrored its success in the overall THOR population within the Asian subgroup, demonstrating superior survival and response rates compared to chemotherapy while maintaining a similar safety profile.
Source: https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/show/session/40
Clinical Trial: https://clinicaltrials.gov/study/NCT03390504
Matsubara N, Loriot Y, Burgess EF, Park SH, Huddart RA, Ku JH, Tran B, Triantos S, Deprince K, Mukhopadhyay S, Hemaya R, Zhuo J, Siefker-Radtke AO. Asian subgroup analysis of the THOR phase III study: Erdafitinib versus chemotherapy in patients with advanced or metastatic urothelial cancer and selected fibroblast growth factor receptor alterations. Presented at the European Society for Medical Oncology (ESMO) Annual Meeting, Presentation Number 208O, Lecture Time 11:45 AM – 11:55 AM.
