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Thomas Flaig, MD
Thomas Flaig, MD
Posted: Tuesday, June 20, 2023
In 266 patients with advanced or metastatic urothelial cancer and select fibroblast growth factor receptor (FGFR) mutations and fusions, all of whom experienced disease progression after anti–PD-L1 therapy, those who received erdafitinib versus investigator’s choice of chemotherapy had significantly improved overall survival, progression-free survival, and overall response rate in the randomized phase III THOR study. The toxicity associated with erdafitinib—an oral selective pan-FGFR tyrosine kinase inhibitor—was consistent with its known safety profile, reported Yohann Loriot, MD, PhD, of Institut Gustave Roussy, Villejuif, France, and colleagues at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA4619).
“These results support the role of erdafitinib to treat patients with FGFR-altered metastatic urothelial cancer after [anti]–PD-L1 treatment,” stated Dr. Loriot and co-investigators.
About 20% of patients with metastatic urothelial cancer have FGFR alterations, noted the team. In this trial, all patients (median age, 67 years; 74% with visceral metastases) had disease progression after one or two prior systemic therapies, one of which was required to be an anti–PD-L1 agent. A total of 90% of all participating patients had PD-L1–low disease.
With a median follow-up of about 16 months, overall survival, the primary endpoint, was 12.1 months with erdafitinib (n = 136) versus 7.8 months with chemotherapy (docetaxel or vinflunine; n = 130), for a reduction in the risk of death of 36%. The overall response rates in the two arms were 46% and 12%, respectively, and median progression-free survival was 5.6 versus 2.7 months.
Serious treatment-related adverse events were reported in 13% and 24% of patients on erdafitinib and chemotherapy, respectively. Grade 3 or 4 treatment-related adverse events were experienced by 46% of patients in each arm.
Disclosure: The study authors’ disclosure information can be found at coi.asco.org.
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