EAU 2026 – J&J strengthens its bladder hand
Erda-iDRS maintains its promise in FGFR mutants, but adverse events could give pause.
Erda-iDRS maintains its promise in FGFR mutants, but adverse events could give pause.
Johnson & Johnson already has one FDA-approved drug-eluting bladder product, and now it’s lining up another, with new early data on Erda-iDRS presented at the European Association of Urology meeting last week.
Response rates look in line with those previously reported, but in more patients – something that should boost hopes for ongoing pivotal trials. However, one potential stumbling block could be safety, with the phase 1 trial showing relatively high discontinuation rates.
FGFR-mutant disease
While J&J’s gemcitabine-eluting product Inlexzo was approved in the US last year for BCG-unresponsive non-muscle invasive bladder cancer, Erda-iDRS (previously known as TAR-210), which releases the FGFR inhibitor erdafitinib, is being developed specifically for patients with FGFR alterations.
J&J already markets an oral erdafitinib formulation as Balversa for second-line FGFR3-altered urothelial carcinoma. The company is attempting to go earlier with Erda-iDRS than Inlexzo, by looking at intermediate-risk, as well as high-risk, NMIBC.
The latest data came from the phase 1 portion of a phase 1/2 trial. Among 62 patients in the intermediate-risk cohort J&J noted a complete response rate of 89%. This is consistent with a 90% complete response rate in 31 patients reported at the American Urology Association meeting in 2024.
Meanwhile, among 26 patients with BCG-experienced, high-risk NMIBC, there was an 83% 12-month recurrence-free survival rate. At AUA 2024, this number was 90% among 21 patients.
In the latest safety dataset of 88 patients, eight (9%) patients discontinued owing to an adverse event, and two (2%) experienced serious treatment-related adverse events, one with pyelonephritis and sepsis and one with haematuria (blood in the urine). Still, there were no treatment-related deaths.
Phase 3
The big test for the project will be in phase 3, where two randomised, controlled trials are ongoing versus intravesical chemo: Moonrise-1, in intermediate-risk NIMBC, and Moonrise-3, in the high-risk post-BCG setting. The latter could end up crossing into the population currently addressed by Inlexzo.
Notable trials of Erda-iDRS (TAR-210) in FGFRm bladder cancer
| Trial | Setting | Regimen | Note |
|---|---|---|---|
| Ph1 trial | NMIBC & MIBC | MonoRx, uncontrolled | Data at EAU 2026: intermediate-risk NMIBC: 89% CR rate; high-risk, BCG-experienced NMIBC: 83% 12-mth recurrence-free survival rate* |
| Ph2 Moonrise-2 (RP2D expansion of above trial) | Intermediate-risk NMIBC | MonoRx, uncontrolled | Primary endpoint is overall complete response |
| Ph3 Moonrise-1 | Intermediate-risk NMIBC | MonoRx, vs intravesical chemo | Started Apr 2024; completes Jun 2028 |
| Ph3 Moonrise-3 | High-risk papillary-only NMIBC, post-adjuvant BCG | MonoRx, vs intravesical chemo | Started Sep 2025; completes Apr 2028 |
Note: *3 Nov 2025 cutoff date in 62 IR-NMIBC pts & 26 HR, post-BCG NMIBC pts. Source: OncologyPipeline & company release.
Meanwhile, Inlexzo is in a phase 3 trial in BCG-naive high-risk NMIBC, Sunrise-3 – although it’s currently unclear when this might read out.
J&J previously said data could be available by 2026, although the trial’s results didn’t appear as a 2026 event in its fourth-quarter 2025 earnings presentation. At the time, a spokesperson declined to say whether the study had been delayed, adding that the group would “share updates as appropriate”.
J&J expects data this year from Sunrise-5, in BCG-unresponsive, papillary-only disease (Inlexzo’s current label is for carcinoma in situ with or without papillary tumours).
The company paid an undisclosed – and presumably small – fee for Taris, Inlexzo and Erda-iDRS’s developer. J&J forecasts peak Inlexzo sales of $5bn, but isn’t yet splitting out sales. Erda-iDRS could bolster the company’s bladder cancer franchise, but still has a long way to go.
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