Prof James Catto, MBChB, PhD, FRCS, University of Sheffield, United Kingdom, discusses the first randomized data from Cohort 1 of the THOR-2 trial investigating erdafitinib vs intravesical chemotherapy in patients with high-risk non–muscle-invasive bladder cancer with select fibroblast growth factor receptor (FGFR) alterations who received prior bacillus calmette-guérin (BCG) therapy.

This data showed that erdafitinib was associated with prolonged recurrence-free survival (RFS) vs chemotherapy among patients with papillary-only high-risk non–muscle-invasive bladder cancer with FGFR alterations whose disease recurred following BCG toxicity.

Dr Catto presented these results at the 2023 ESMO Congress in Madrid, Spain.

Transcript:

Hi, we're here at ESMO 2023 in Madrid. My name's Jim Catto. I'm a urological surgeon from the University of Sheffield. I'm going to talk about erdafitinib and the THOR-2 trial.

Patients with bladder cancer are really common, and those with high risk intermediate-risk non-muscle-invasive disease have got very few treatment options if they fail [bacillus calmette-guérin] BCG therapy. We are looking at targeted treatment in this population. Erdafitinib is an oral agent that inhibits FGFR tyrosine kinase receptors and therefore, targets that pathway.

We screened just under 1000 patients and found a third have got FGFR mutations such that they could be targeted by erdafitinib. We randomized in a 2 arm study, 2-to-1 against standard of care. Standard of care was intravesical treatment of another choice: gemcitabine, mitomycin, or hypothermic therapy and the treatment arm got erdafitinib.

In total, 73 patients were randomized in a 2-to-1 fashion. We've got follow-up now up to 13.4 months. What we saw, our primary outcome was recurrence-free survival. Recurrence-free survival wasn't reached in the erdafitinib arm, but in the control arm was 11 months. We saw a significant reduction in recurrence with erdafitinib, and the hazard ratio is 0.28. In other words, there's a 72% reduction in recurrence if you had erdafitinib.

However, side effects were really common. All the patients on erdafitinib got 1 or more side effects and a third of patients had to stop the drug because of the toxicity. Going forward, it's a very effective treatment, biomarkers are the way to proceed in this disease. But we need to look at more local delivery of erdafitinib. And there's a new product called the TAR-210, TARIS, which is going to do that.

Source:

Catto JWF, Tran B, Roupret M, et al. THOR-2 cohort 1: Results of erdafitinib (ERDA) vs intravesical chemotherapy (chemo) in patients (pts) with high-risk non– muscle-invasive bladder cancer (HR NMIBC) with select fibroblast growth factor receptor alterations (FGFRALT) who received prior bacillus calmette-guérin (BCG) treatment. Presented at: 2023 ESMO Annual Congress; October 20-24, 2023; Madrid, Spain. Abstract LBA102.