Siamak Daneshmand, MD, discusses initial findings from the phase 2b SUNRISE-1 trial exploring the novel intravesical chemotherapy delivery system TAR-200 in non–muscle-invasive bladder cancer.
Siamak Daneshmand, MD, discusses initial findings from the phase 2b SUNRISE-1 trial, which he presented at the 2023 AUA Annual Meeting. The results showed that the novel intravesical chemotherapy delivery system TAR-200 elicited complete responses (CRs) in nearly three-fourths of patients with BCG-unresponsive, high-risk non–muscle-invasive bladder cancer (NMIBC).
TAR-200 works by providing continuous low-doses of localized gemcitabine via insertion into the bladder. The SUNRISE-1 data shared at AUA showed that TAR-200 achieved a CR rate of 72.7% (95% CI, 49.8-89.3), consisting of 16 CRs in 22 evaluable patients.
Further, at a median follow-up of 10.6 months, 15 of the 16 CRs remained ongoing and the median duration of response was not reached. Of the complete responders, 6 maintained their response for more than 12 months, and none of the complete responders had disease recurrence or progression.
SUNRISE-1 is also assessing the PD-1 inhibitor cetrelimab in this setting, and the initial data showed that the CR rate with single-agent cetrelimab was 38.1% (95% CI, 18.1-61.6), consisting of 8 CRs among 21 evaluable patients.
Overall, patients in SUNRISE-1 are being randomized to 3 treatment arms: cohort 1 is TAR-200 dosed every 3 weeks for up to 24 weeks, then every 12 weeks until week 96 (year 2) plus cetrelimab dosed every 3 weeks through week 78; cohort 2 is TAR-200 alone at the same dose as cohort 1; and cohort 3 is cetrelimab alone dosed at the same dose as cohort 1.
Daneshmand is a professor of Urology, director of Clinical Research, Keck Medicine of USC.