Javlor (vinflunine)

P3, N=608, Active, not recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Aug 2025 --> Nov 2025

P3, N=712, Completed, Gilead Sciences | Active, not recruiting --> Completed

Erdafitinib showed improved survival compared with chemotherapy, with no new safety concerns in the Asian subpopulation. These findings were consistent with those for the overall study population in THOR Cohort 1 who received prior anti-PD-(L)1 therapy.

P3, N=608, Active, not recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Apr 2025 --> Aug 2025

P3, N=696, Active, not recruiting, Gilead Sciences | Trial completion date: Jul 2025 --> Oct 2025 | Trial primary completion date: Jul 2025 --> Oct 2025

P3, N=608, Active, not recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Aug 2024 --> Feb 2025

P3, N=696, Active, not recruiting, Gilead Sciences | Trial completion date: Oct 2024 --> Jul 2025 | Trial primary completion date: Oct 2024 --> Jul 2025

An anchored MAIC was conducted according to the National Institute for Health and Care Excellence Decision Support Unit guidance, with physician's choice of chemotherapy (docetaxel/paclitaxel and vinflunine) as the common comparator. The MAIC indicates comparable efficacy of erdafitinib vs EV for overall survival and progression-free survival, with erdafitinib showing a higher probability of achieving deep responses. While erdafitinib is associated with slightly more adverse events compared with EV, these events seem to be less severe.

These novel combinations are revolutionizing the treatment standard for metastatic urothelial carcinoma and necessitate a new approach to managing side effects.

In the Japanese subgroup, erdafitinib showed improved survival and response compared to chemotherapy, with no new safety concerns. These results support erdafitinib as a treatment option for Japanese mUC patients with FGFR alterations, and early FGFR testing after diagnosis of mUC should be considered.

P3, N=629, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2024 --> Nov 2026

THOR-1 trial showed a significant overall survival benefit with erdafitinib (FGFR inhibitor) vs chemotherapy (taxane or vinflunine) in patients with advanced urothelial carcinoma of the bladder (UCB) or upper tract urothelial carcinoma (UTUC). Although histologically similar, the genomic landscape of FGFR3mut+ RPUC and UUC has notable differences with FGFR3mut+ UCB. Limitations include lack of clinical data annotation, inherent selection biases, and the retrospective nature of this work. Findings may impact clinical trial designs for UCB and UTUC, including evaluating combinations of anti-FGFR3 with other agents.