SunRISe-1 knowledge of TAR-200 in NMIBC revealed in Journal of Clinical Oncology

Data from the part 2b SunRISe-1 trial (NCT04640623) have been revealed within the Journal of Clinical Oncology, displaying that TAR-200 monotherapy achieved excessive full response charges and extended disease-free survival (DFS) in sufferers with BCG-unresponsive high-risk non–muscle invasive bladder most cancers (NMIBC).¹

Overall, the SunRISe-1 trial is assessing the security and efficacy of TAR-200 together with cetrelimab (cohort 1; n = 53), TAR-200 monotherapy (cohort 2; n = 85), and cetrelimab monotherapy (cohort 3; n =28) in sufferers with BCG-unresponsive high-risk NMIBC with carcinoma in situ (CIS). The trial additionally features a fourth cohort assessing TAR-200 monotherapy in sufferers with BCG-unresponsive papillary disease-only high-risk NMIBC (n = 52).

Cohort 2

Among the 85 sufferers enrolled in cohort 2 of the trial, the centrally confirmed full response (CR) charge was 82.4% (95% CI, 72.6 to 89.8). The median period of response (DOR) was 25.8 months (95% CI, 8.3 to NE), with 52.9% of responders (37 of 70) attaining a DOR of not less than 12 months.

According to the authors, excessive CR charges had been noticed throughout all clinically related subgroups, together with in these with and with out concurrent papillary illness (82.1% to 82.5%, respectively).

The 12- and 24-month radical cystectomy-free charges had been 86.6% (95% Ci, 76.6 to 92.6) and 75.5% (95% CI, 63.4 to 84.1), respectively. Overall survival (OS) charges at 6- and 12-months had been 98.7% (95% CI, 91.2 to 99.8) and 94.7% (95% CI, 86.5 to 98.0), respectively.

Treatment-related antagonistic occasions (TRAEs) of any grade had been reported in 83.5% of sufferers. The commonest TRAEs included pollakiuria (43.5%), dysuria (40%), micturition urgency (24.7%), and urinary tract an infection (21.2%). TRAEs led to therapy interruptions in 31.8% of sufferers and therapy discontinuation in 3.5% of sufferers.

Grade 3 or greater AEs had been reported in 12.9% of sufferers, with essentially the most frequent being urinary tract ache (4.7%). Serious TRAEs occurred in 5.9% of sufferers.

Cohort 4

Cohort 4 of the trial assessed TAR-200 monotherapy in 52 sufferers with papillary disease-only.

At a median follow-up of 12.8 months, the median DFS was not estimable. DFS charges at 6-, 9-, and 12-months had been 85.3% (95% CI, 71.6 to 92.7), 81.1% (95% CI, 66.7 to 89.7), and 70.2 (95% CI, 51.6 to 82.8), respectively. In sufferers with high-grade Ta and T1 illness, the 12-month DFS charges had been 70.0% (95% CI, 44.8 to 85.4) and 72.2% (95% CI, 44.8 to 87.6), respectively.

TRAEs had been noticed in 80.8% of sufferers. Grade 3 or greater TRAEs occurred in 13.5% of sufferers, and critical TRAEs had been reported in 5.8% of sufferers. In whole, 4 sufferers (7.7%) discontinued therapy as a consequence of TRAEs.

Cohorts 1 and three

In cohorts 1 and three, the CR charges had been 67.9% (95% CI, 53.7-80.1) and 46.4% (95% CI, 27.5-66.1), respectively. The median DOR was not estimable in cohort 1 and was 8.6 months (95% CI, 2.8 to NE) in cohort 3. The 12-month DOR charges had been 76.3% (95% CI, 58.1 to 87.4) and 38.5% (95% CI, 14.1 to 62.8) in cohorts 1 and three, respectively.

Grade 3 or greater TRAEs occurred in 37.7% of sufferers in cohort 1 and seven.1% of sufferers in cohort 3. Serious TRAEs had been reported in 15.1% and three.6% of sufferers, respectively.

Based on these knowledge, the authors famous, “TAR-200 monotherapy offered a more favorable risk-benefit profile vs TAR-200 plus cetrelimab or cetrelimab alone in BCG-unresponsive CIS.”

About TAR-200

TAR-200 is an investigational intravesical gemcitabine releasing system that’s “designed to provide sustained local delivery of a cancer treatment into the bladder,” in response to Johnson & Johnson.² The FDA not too long ago granted precedence assessment to the brand new drug utility (NDA) for TAR-200 in BCG-unresponsive high-risk NMIBC with CIS with or with out papillary tumors based mostly on knowledge from cohort 2 of the SunRISe-1 trial.

“With an 82.4% complete response rate and durable outcomes extending beyond 2 years, TAR-200 sets a new benchmark for bladder-sparing treatment in patients with BCG-unresponsive non–muscle-invasive bladder cancer,” mentioned lead creator Siamak Daneshmand, MD, director of urologic oncology on the University of Southern California, in correspondence with Urology Times®. “The SunRISe-1 trial establishes TAR-200 as a promising novel intravesical therapy for patients who are ineligible for or decline radical cystectomy.”

REFERENCES

1. Daneshmand S, Heijden MSV, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder most cancers: Results from the part IIb SunRISe-1 examine. J Clin Oncol. 2025:101200JCO2501651. doi:10.1200/JCO-25-01651

2. Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder most cancers. News launch. Johnson & Johnson. July 17, 2025. Accessed July 31, 2025.