SunRISe-1
A tiny pretzel-shaped device that slowly releases chemotherapy inside the bladder cleared carcinoma in situ in over 80% of patients whose BCG had failed.
Cohort 2 (TAR-200 alone): confirmed CR 82%; 51% remained in CR at 1 year; 98% of responses within 12 weeks. FDA approval of Inlexzo (gemcitabine intravesical system) on 9 September 2025 for BCG-unresponsive NMIBC with CIS. Cetrelimab added little. Phase 3 SunRISe-3 (BCG-naive) and SunRISe-4 (MIBC) ongoing.
Setting
BCG-unresponsive high-risk NMIBC with carcinoma in situ: TAR-200 (gemcitabine intravesical system) ± cetrelimab, single-arm cohorts
Phase
Phase 2
Sponsor
Johnson & Johnson
Registry
Headline result
CR 82%; 51% in CR at 12 months.
Reported
2024
Replication
Single-arm registrational cohort; randomised confirmation in SunRISe-3 pending.
In plain words
What these results mean for people, not percentages
Complete response rate (CIS)primaryresponse endpoint
- 82 out of 100 people had their tumour shrink with TAR-200 monotherapy.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
Duration of CR ≥12 monthssurrogate endpoint
- 51 out of 100 people reached this endpoint with TAR-200 monotherapy.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Be careful
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- These results apply to the people the trial enrolled: BCG-unresponsive high-risk NMIBC with carcinoma in situ: TAR-200 (gemcitabine intravesical system) ± cetrelimab, single-arm cohorts. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Complete response rate (CIS)primary
TAR-200 monotherapy82 of 100
n = 85
Duration of CR ≥12 months
TAR-200 monotherapy51 of 100
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete response rate (CIS)primary | TAR-200 monotherapy | 85 | 82% | — | — | — |
| Duration of CR ≥12 months | TAR-200 monotherapy | — | 51% | — | — | — |
Replication
Single-arm registrational cohort; randomised confirmation in SunRISe-3 pending.