# SunRISe-1

Source: https://onco.cc/trials/sunrise-1/  
OnCo record `sunrise-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04640623
- Phase: 2
- Setting: BCG-unresponsive high-risk NMIBC with carcinoma in situ: TAR-200 (gemcitabine intravesical system) ± cetrelimab, single-arm cohorts
- Sponsor: Johnson & Johnson
- Result: CR 82%; 51% in CR at 12 months.
- Outcomes: Complete response rate (CIS): TAR-200 monotherapy 82%; Duration of CR ≥12 months: TAR-200 monotherapy 51%
- Replication: Single-arm registrational cohort; randomised confirmation in SunRISe-3 pending.

## Sources

- ClinicalTrials.gov NCT04640623: https://clinicaltrials.gov/study/NCT04640623
- FDA approval of Inlexzo: https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- technologies: [Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)](https://onco.cc/technologies/bcg-and-intravesical-therapy/)
- drugs: [Gemcitabine intravesical system (TAR-200)](https://onco.cc/drugs/tar-200/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- terms: [BCG-unresponsive](https://onco.cc/terms/bcg-unresponsive/)
- people: [Andrea Necchi](https://onco.cc/people/andrea-necchi/)
- roadmaps: [Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants](https://onco.cc/roadmaps/devices-roadmap/)

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