(Urothelial Cancer) Is Erdafitinib Effective?

• July 31, 2023
• Read time: 2 minutes

From June 2–6, 2023, Yohann Loriot et al. of Gustave Roussy Institute presented at ASCO 2023 in Chicago, USA, the efficacy and safety of Erdafitinib in the THOR Phase 3 clinical trial for FGFR-altered advanced urothelial cancer patients with prior immune checkpoint inhibitor therapy.

The THOR Phase 3 clinical trial randomly assigned FGFR-altered advanced urothelial cancer patients with prior immune checkpoint inhibitor therapy in a 1:1 ratio to the Erdafitinib group (once daily 8 mg, maximum 9 mg, N=136) or the chemotherapy group (N=130). The primary endpoint was overall survival, and secondary endpoints were progression-free survival, objective response rate, and safety.

Patient demographics: Median age was 66 years in the Erdafitinib group and 69 years in the chemotherapy group. Metastatic disease: Erdafitinib group 74.3%, chemotherapy group 74.6%. Low PD-L1 expression: Erdafitinib group 92.7%, chemotherapy group 86.1%. Prior first-line treatment: Erdafitinib group 33.1%, chemotherapy group 25.4%. Prior second-line treatment: Erdafitinib group 66.2%, chemotherapy group 74.6%.

Primary endpoint median overall survival: Erdafitinib group 12.1 months / chemotherapy group 7.8 months — the Erdafitinib group showed significant improvement.

Secondary endpoint median progression-free survival: Erdafitinib group 5.6 months / chemotherapy group 2.7 months — the Erdafitinib group showed significant improvement. Objective response rate: Erdafitinib group 46% / chemotherapy group 12% — the Erdafitinib group was significantly higher.

Regarding safety, the incidence of Grade 3–4 adverse events was: Erdafitinib group 46% / chemotherapy group 46%. Serious adverse event incidence: Erdafitinib group 13% / chemotherapy group 24%. Treatment-related deaths: Erdafitinib group 1 patient / chemotherapy group 6 patients.

Based on the THOR trial results, Yohann Loriot et al. stated: In FGFR-altered advanced urothelial cancer patients with prior immune checkpoint inhibitor therapy, Erdafitinib treatment showed improvement in overall survival, progression-free survival, and objective response rate compared to chemotherapy.

Source: https://meetings.asco.org/abstracts-presentations/226592

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