SunRISe-1: trial | Bending the Curve: Trial by Trial

SunRISe-1

TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study

Phase 2NCT04640623

Population

Adults with BCG-unresponsive high-risk non-muscle-invasive bladder cancer ineligible for or refusing radical cystectomy: carcinoma in situ with or without papillary disease (cohorts 1-3) or papillary disease only (cohort 4).

Design

Phase IIb parallel-cohort study at 142 sites in 14 countries (enrolment March 2021 to April 2024) in BCG-unresponsive high-risk NMIBC ineligible for or refusing radical cystectomy. Carcinoma in situ (with or without papillary disease): TAR-200 alone (cohort 2), TAR-200 plus cetrelimab (cohort 1) or cetrelimab alone (cohort 3). Papillary disease only: TAR-200 alone (cohort 4). TAR-200 dosed through month 24 and cetrelimab through month 18. Primary endpoints: centrally confirmed overall complete response rate (cohorts 1-3) and disease-free survival rate (cohort 4). Data cutoff 31 March 2025. Per the full text, the three CIS cohorts were originally designed to enrol 200 patients randomly assigned 2:1:1 to cohorts 1, 2 and 3; in June 2023 enrolment in cohorts 1 and 3 was closed, the TAR-200 alone cohort was expanded to about 80 patients and cohort 4 was added. The paper reports no statistical comparisons between cohorts.

Primary endpoint

Complete response in carcinoma in situ, DFS

Arms

Cohort 1: TAR-200 plus cetrelimab (experimental, n = 53): TAR-200 (through month 24) plus cetrelimab (through month 18)
Cohort 2: TAR-200 alone (experimental, n = 85): TAR-200 through month 24
Cohort 3: cetrelimab alone (experimental, n = 28): Cetrelimab through month 18
Cohort 4: TAR-200 alone, papillary disease only (experimental, n = 52): TAR-200 through month 24

People

Daneshmand S

Show the numbers

Results reported for SunRISe-1
Endpoint	Analysis	Cohort 1: TAR-200 plus cetrelimab / Cohort 2: TAR-200 alone / Cohort 3: cetrelimab alone / Cohort 4: TAR-200 alone, papillary disease only	Control	Effect
Complete response in carcinoma in situAll enrolled patients who received at least one dose, with BCG-unresponsive carcinoma in situ in cohorts 1-3 (cohort 2 N=85, cohort 1 N=53, cohort 3 N=28); the paper does not label this intention-to-treatCentrally confirmed overall complete response rate	primaryDaneshmand 2025	82.4% (72.6–89.8%)	—	Cohort 2: 70 of 85 patients (full text). The cohorts were not statistically compared with each other (full text); the paper's conclusion favours TAR-200 alone on risk-benefit.
DORCohort 2 responders	primaryDaneshmand 2025	median 25.8 months	—	95% confidence interval 8.3 months to not estimable (upper bound not stored as a number). Median follow-up in responders 20.2 months (range 5-48); 37 of 70 responders had a duration of response of 12 months or more (full text Table 2).
DFSCohort 4: treated patients with BCG-unresponsive high-risk papillary disease only	primaryDaneshmand 2025	85.3% at 6 mo (71.6–92.7%); 81.1% at 9 mo (66.7–89.7%); 70.2% at 12 mo (51.6–82.8%)	—	Median DFS not estimable after median follow-up 12.8 months (range 4-17) (full text).
Grade 3 or worse treatment-related adverse eventsTreated patients in each cohort	primaryDaneshmand 2025	12.9%	—	Serious treatment-related adverse events 5.9%, 5.8%, 15.1% and 3.6% in cohorts 2, 4, 1 and 3 respectively. No treatment-related deaths.

Results reported for SunRISe-1
Endpoint	Analysis	Cohort 1: TAR-200 plus cetrelimab / Cohort 2: TAR-200 alone / Cohort 3: cetrelimab alone / Cohort 4: TAR-200 alone, papillary disease only	Control	Effect
Complete response in carcinoma in situAll enrolled patients who received at least one dose, with BCG-unresponsive carcinoma in situ in cohorts 1-3 (cohort 2 N=85, cohort 1 N=53, cohort 3 N=28); the paper does not label this intention-to-treatCentrally confirmed overall complete response rate	primaryDaneshmand 2025	82.4% (72.6–89.8%)	—	Cohort 2: 70 of 85 patients (full text). The cohorts were not statistically compared with each other (full text); the paper's conclusion favours TAR-200 alone on risk-benefit.
DORCohort 2 responders	primaryDaneshmand 2025	median 25.8 months	—	95% confidence interval 8.3 months to not estimable (upper bound not stored as a number). Median follow-up in responders 20.2 months (range 5-48); 37 of 70 responders had a duration of response of 12 months or more (full text Table 2).
DFSCohort 4: treated patients with BCG-unresponsive high-risk papillary disease only	primaryDaneshmand 2025	85.3% at 6 mo (71.6–92.7%); 81.1% at 9 mo (66.7–89.7%); 70.2% at 12 mo (51.6–82.8%)	—	Median DFS not estimable after median follow-up 12.8 months (range 4-17) (full text).
Grade 3 or worse treatment-related adverse eventsTreated patients in each cohort	primaryDaneshmand 2025	12.9%	—	Serious treatment-related adverse events 5.9%, 5.8%, 15.1% and 3.6% in cohorts 2, 4, 1 and 3 respectively. No treatment-related deaths.

Illustrative — modelled from reported values, not trial data. DOR, primary.

Show curves

Cohort 2: TAR-200 alone (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Cohort 2: TAR-200 alone
0	100.0%
16	65.1%
32	42.3%
48	27.5%
65	17.4%

Illustrative — modelled from reported values, not trial data. DFS, primary.

Show curves

Cohort 4: TAR-200 alone, papillary disease only (experimental)

Data table (modelled values)

Months	Cohort 4: TAR-200 alone, papillary disease only
0	100.0%
3	92.3%
6	85.3%
10	78.0%
13	70.2%

Appears in

2025 TAR-200 for BCG-unresponsive high-risk NMIBC

Sources

Daneshmand S, Van der Heijden MS, Jacob JM, Guerrero-Ramos F, Bögemann M, Simone G, et al. TAR-200 for Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. J Clin Oncol. 2025;43(33):3578-3588.
PubMed DOI