尿路上皮癌靶向药问世，厄达替尼的有效率和生存期数据介绍

Erdafitinib is a kinase inhibitor that binds to and inhibits the enzymatic activities of FGFR1, FGFR2, FGFR3, and FGFR4. Erdafitinib also binds to RET, CSF1-R, PDGFRA, PDGFRB, FLT4, KIT and VEGFR2. Inhibits FGFR phosphorylation and signal transduction and reduces cell viability in cell lines expressing altered FGFR genes, including point mutations, amplifications and fusions. Erdafitinib shows antitumor activity in FGFR-expressing cell lines and xenograft models from tumors, including bladder cancer.

BLC2001 (NCT02365597) is a multicenter, open-label Phase 2 clinical study. The focus of enrollment is patients with urothelial cancer that has progressed after chemotherapy and patients who are ineffective in immunotherapy. Patients carry at least one FGFR3 mutation or FGFR2/3 fusion, and their ECOG score is within 2 points. The primary study endpoint is ORR (objective response rate), and secondary endpoints include PFS (progression-free survival), DOR (duration of sustained response), and OS (overall survival).

The results showed that the PFS evaluated by the researchers was 5.5 months, the OS was 13.8 months, and the ORR of erdafitinib was 40%. Among 99 patients, 74 patients had FGFR mutations, and their ORR was 49%; the ORR in the group that did not receive chemotherapy was 42%, and the ORR in the group that progressed or relapsed after chemotherapy was 40%; 25 patients had FGFR fusions, and their ORR was 16%; the ORR of 22 patients who had received immunotherapy before enrollment was as high as 59%.

Grade 3 and 4 adverse reactions (AEs) for erdafitinib reached 67%, and treatment-related AEs reached 46%. Common among these grade 3 and 4 AEs were hyponatremia, oral mucosal disease, and asthenia. Thirteen patients stopped treatment due to AEs, and 55 patients reduced their dosage due to AEs such as oral mucosal disease and hyperphosphatemia. AEs resulted in discontinuation of treatment in 13% of patients and there were no treatment-related deaths.

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