Erdafitinib shows activity in intermediate-risk NMIBC with FGFR3 mutations

Erdafitinib shows ‘promising anti-tumor activity’ in patients with intermediate-risk non-muscle-invasive bladder cancer (NMIBC) FGFR3 mutations, according to the researchers.

These patients had an overall response rate of 94% and a complete response rate of 83%. No new safety signals were identified, but treatment-related adverse events (TRAEs) were prevalent and work is underway to reduce toxicity, the researchers said.

These results are from Cohort 3 of the phase 2 THOR-2 study (ClinicalTrials.gov identifier: NCT04172675). The results were presented in a poster at the 2023 Society of Urological Oncology Annual Meeting.

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The cohort included 18 patients with recurrent grade 1-2 Ta/T1 intermediate-risk NMIBC.The median age of patients was 63.5 (range 47-77) years, 50% of patients were male, and all had FGFR3

mutation.

Nearly all visible bladder tumors in patients are removed by resection or electrocautery. Leave a tumor (5-10 mm) as a marker lesion.

The patient received erdafitinib at a dose of 6 mg once daily for 28 days. They can continue treatment for up to 2 years or until high-risk disease recurrence, intolerable toxicity, withdrawal of consent, investigator decision, or study end.

The median follow-up time was 10.0 months, and the median treatment duration was 7.1 months. The overall response rate was 94.4%. Fifteen patients achieved complete response (83.3%), 2 patients achieved partial response (11.1%), and 1 patient experienced high-grade relapse.

The median time to response was 1.15 months, the median duration of response was 12.7 months, and 12 patients had ongoing responses at the time of data cutoff.

All 18 patients experienced TRAEs. These included hyperphosphatemia (n=18), dry mouth (n=13), diarrhea (n=11), dysgeusia (n=9), dry skin (n=7), palmoplantar erythrodysesthesia syndrome (n=6), fatigue (n=6), abdominal pain (n=3) and gastritis (n=1).

An additional three patients experienced grade 1 central serous retinopathy events. The event resolved in 1 patient but was ongoing in 2 patients at last follow-up. Three patients discontinued treatment due to TRAEs.

The researchers noted that efforts are underway to reduce systemic toxicity using TAR-210, “a novel intravesical delivery system that provides sustained local release of erdafitinib within the bladder while limiting systemic exposure.”

Data from THOR-2 Cohort 2 were also presented at the meeting.

Disclosure: This research was supported by Janssen Research and Development. Some study authors are employed by the company. One author disclosed relationships with Janssen, Photocure, Taris, Ferring, QED Therapeutics, Olympus, Pacific Edge, Johnson & Johnson, Aduro Biotech, Bristol Myers Squibb, and Allergan.

refer to

Daneshmand S, Zaucha R, Vasdev N, et al. Marker lesion study of oral erdafitinib in patients with FGFR3/2-altered intermediate-risk non-muscle-invasive bladder cancer in the THOR-2 study: updated cohort 3 results. Published at SUO 2023. November 28 to December 1, 2023. Washington DC. Poster 134.