“In other words, there's a 72% less chance of recurrence with oral erdafitinib than with standard of care. The problem is tolerability,” says James W.F. Catto, PhD, FRCS.
In this video, James W.F. Catto, PhD, FRCS, highlights findings from cohort 1 of the phase 2 THOR-2 trial (NCT04172675) exploring oral erdafitinib vs chemotherapy in patients with high-risk non–muscle-invasive bladder cancer, which he presented at the 2023 European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain.Catto is a professor in the department of oncology and metabolism at the University of Sheffield in the UK.
Bladder cancer is a really common disease, and about a third of patients have high-risk non-invasive bladder cancer. The treatment for that is BCG after resection, but about half the patients fail BCG, and then they have very limited treatment options. The standard of care is blood removal, so radical cystectomy, but that has a big impact on quality of life and is a major operation. Only about a fifth of patients get that. So, we were looking at treatment options that you could do in that situation. Erdafitinib is a tyrosine kinase pan FGFR inhibitor that's orally active, and it works. It's been licensed to work in metastatic advanced urothelial bladder cancer. We looked at a cohort of patients where we screened their primary tumors for FGF alterations. If they had an FGF alteration in FGFR 2 or 3, we then randomized them to orally active erdafitinib or the standard of care, which was intravesical cycle chemotherapy either gemcitabine on mitomycin. We had 73 people recruited, 2:1 randomization, so 49 for erdafitinib, and the rest got chemotherapy.
We've now got follow-up up to 13 months. The response rates are really good for erdafitinib. Overall, we haven't reached recurrence-free survival for erdafitinib, although for the control arm it was 11 months in total, median follow-up of 13.4%. The hazard ratio is 0.28. In other words, there's a 72% less chance of recurrence with oral erdafitinib than with standard of care. The problem is tolerability. All patients had side effects with erdafitinib, and a third of them had to stop the drug because of the toxicity. In the long run, I think it's a very active product, but perhaps an orally active systemic treatment is not the right one for a localized disease. As a consequence, we're now looking at the TAR-210, which is a drug loaded stent, which sits in the bladder, and it has erdafitinib with it.
This transcription has been edited for clarity.